Myelodysplastic syndromes (MDS) trials

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This trial tests adding the drug ruxolitinib to standard graft-versus-host disease (GVHD) prevention around an allogeneic stem cell transplant for older adults with myelofibrosis or MDS/MPN overlap syndromes. It has two parts: before, during, and after transplant, with ruxolitinib started before conditioning and continued for up to about a year (with taper) along with standard GVHD meds. It is for adults who are candidates for allogeneic HCT and have MF or MDS/MPN overlap, with most participants up to age 75 (some over 75 if health criteria are met). Key exclusions include contraindication to ruxolitinib, active uncontrolled infections, HIV, untreated TB, pregnancy, or a history of prior allogeneic transplant, and recent MI, stroke, or unprovoked clotting within 6 months.

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- The study tests DISC-0974 in adults with myelofibrosis or myelodysplastic syndrome who also have anemia. - It is a phase 1b/2a open-label trial aimed at safety, tolerability, pharmacokinetics, pharmacodynamics, and to categorize anemia response. - There are MF participants (with various risk levels) and an exploratory cohort of participants with MDS and anemia. - Key exclusions include active infections (HBV/HCV or HIV with detectable viral load), recent hematopoietic stem cell transplant or related immunosuppression, recent iron chelation therapy, pregnancy, and significant heart disease. - The study is currently recruiting.

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This trial tests adding Intensity Modulated Total Marrow Irradiation (IM-TMI), a targeted form of radiation, to the standard conditioning before a haploidentical stem cell transplant. It is for adults aged 18-75 with a related haploidentical donor (at least 5/10 HLA match) and certain high-risk blood cancers, such as relapsed or refractory AML or ALL, or poor-risk AML/ALL in remission, or poor-risk MDS. The goal is to see if IM-TMI increases cancer cell kill in the bone marrow and reduces relapse after transplant. Exclusion highlights include significant organ problems, inability to consent, or prior radiation to more than 20% of bone marrow–containing areas.

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This study tests whether giving preemptive CIML natural killer (NK) cells expanded with IL-2 after a stem cell transplant can prevent relapse in adults with AML, MDS, or MDS/MPN overlap who are at high risk after transplant. It is for adults undergoing a reduced-intensity conditioning allogeneic stem cell transplant from a related donor, and plans to enroll up to about 30 participants. The trial aims to learn about the safety and potential effectiveness of CIML NK cell therapy plus IL-2 over a follow-up period of up to 3 years, with various monitoring tests along the way. Key exclusions include active infection or uncontrolled illness, pregnancy or inability to use contraception, HIV, active hepatitis B or C, prior allogeneic transplant within 7 days of infusion, and certain donor antibody or steroid-use restrictions.

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- This trial tests the drug momelotinib in adults with VEXAS syndrome, with or without associated myelodysplastic syndrome (MDS). - It has two steps: a safety run-in to find the maximum tolerated dose, followed by a phase II part where patients receive momelotinib at that dose. - All participants will also receive glucocorticoids at baseline, and responses for VEXAS symptoms are evaluated at weeks 4, 12, 24, and 48, with MDS features assessed at weeks 12 and 24. - Eligible participants are adults with UBA1-mutant VEXAS requiring immunosuppressive treatment, but key exclusions include prior JAK inhibitors for VEXAS, high-risk MDS or planned allogeneic transplant, uncontrolled infections, significant cardiovascular disease, and inability to tolerate at least 100 mg/day of momelotinib.

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This is a multicenter screening study to find out how often the KIT D816V mutation occurs in people with suspected clonal mast cell disease. It has three cohorts: Cohort 1 includes people with suspected systemic mast cell activation disease; Cohort 2 includes people with hypermobility-related conditions, POTS, or early osteoporosis/osteopenia; Cohort 3 includes people with certain myeloid disorders per WHO criteria. The study aims to learn the prevalence of the KIT D816V mutation in these groups to inform diagnosis and future research. Exclusions include prior diagnosis of KIT-mutated monoclonal mast cell activation syndrome, cutaneous mastocytosis only, any systemic mastocytosis subtype, or mast cell sarcoma; Cohort 2 also excludes osteoporosis/osteopenia due to other known causes.

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This randomized, controlled trial tests whether Romiplostim N01 can help platelets recover after haploidentical HSCT in adults with malignant blood diseases. About 130 patients will be assigned 1:1 to receive Romiplostim N01 (subcutaneous, weekly, starting at 5 µg/kg and up to 10 µg/kg, for up to 4 weeks or until platelets reach ≥100 × 10^9/L) or no rh-TPO/TPO-RA. The main goal is to see if Romiplostim increases the cumulative platelet engraftment by day +21, with additional measures of time to engraftment, transfusion needs, and safety. Key exclusions include uncontrolled infection or active malignancy, severe cardiovascular disease or thromboembolic risk, recent use of rh-TPO or TPO-RA, anticoagulation for thrombosis, and inability to consent.

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This Mayo Clinic-sponsored trial, currently recruiting, tests delivering cancer treatment at home versus in the clinic for adults with advanced cancer who are already receiving standard therapy. It aims to learn how the home-based approach affects patient experiences, preferences, comfort with home infusions, and overall quality of life compared with usual clinic care. The study also looks at safety of home administration with remote monitoring, and outcomes like emergency room visits, hospitalizations, and overall survival. Eligible participants are adults with various cancer types on eligible regimens, but those who need 24/7 assistance with daily activities, are currently inpatient, or have uncontrolled illness may be excluded.

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211^At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia is being studied. Conditions: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia +9 • Eligibility: Inclusion Criteria: * Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions: * AML, ALL, or MPAL in…. Goal: This phase I/II trial studies the side effects and best dose of 211\^astatine(At)-BC8-B10 before donor stem cell transplant in treating patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, or mixed-phenotype acute leukemia. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant. Phase/Status/Sponsor: Unknown phase; RECRUITING; Fred Hutchinson Cancer Center.

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This trial tests MT-401-OTS, a cellular therapy, in adults with relapsed AML or high/very-high-risk MDS to evaluate safety and potential efficacy at escalating doses. It enrolls two groups of participants aged 65 and older: those with intermediate/high-risk AML with MRD or low blasts after prior therapy, and those with high/very-high-risk MDS with residual disease after HMA therapy. It is a Phase 1, open-label, multicenter dose-escalation study (3+3 design) to find a safe dose and gather early efficacy data, with an optional Cohort 4 for alternative dosing. Key exclusions include active CNS leukemia, active infections (e.g., HIV or hepatitis B/C), prior stem cell transplant, other active cancers (with limited exceptions), significant cardiac disease, and pregnancy.

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SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry is being studied. Conditions: Cancer, Metastatic, Cancer, Cancer of Pancreas +40 • Eligibility: Inclusion Criteria: * Pts with solid and hematological malignancies; * Pts cancer-related biomarkers, gene variants, fusion and rearrangements (by immunohistochemistry, PCR, FISH or NGS): PD-L1, MSI (MMR), Claudin18.2,…. Goal: International registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention. Phase/Status/Sponsor: Unknown phase; RECRUITING; Massive Bio, Inc..

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211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome is being studied. Conditions: Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome, Acute Myeloid Leukemia in Remission +9 • Eligibility: Inclusion Criteria: * Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions: * AML, ALL, or MPAL in…. Goal: This phase I/II trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). 211At-BC8-B10 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Phase/Status/Sponsor: Unknown phase; RECRUITING; Fred Hutchinson Cancer Center.

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This phase II trial tests decitabine given together with one of three drugs—ruxolitinib, fedratinib, or pacritinib—before a donor stem cell transplant for people with accelerated or blast phase myeloproliferative neoplasms. The study aims to learn how well this pre-transplant therapy works to control disease and support transplant success. Eligible participants are adults with a history of MPN and at least 5% blasts in bone marrow or blood; key exclusions include pregnancy, active infection, and certain drug interactions or prior treatments that can’t be managed. Treatment cycles include intravenous decitabine plus one of the inhibitors, with blood and bone marrow samples collected, and follow-up for up to 5 years.

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- This platform trial tests post-transplant cyclophosphamide-based strategies to prevent graft-versus-host disease after a mismatched unrelated donor peripheral blood stem cell transplant in adults with hematologic cancers. - It compares a new drug combination to a standard one and aims to learn which works best and is safest for GVHD prevention. - Eligible participants are adults (18 and older) receiving MMUD PBSC transplant after myeloablative or reduced-intensity conditioning, with a partially matched donor (4/8–7/8) and adequate organ function and performance status. - Key exclusions include not having a suitable donor (no 8/8 match), prior allogeneic transplant, active infection, pregnancy, or enrollment in another GVHD prevention trial.

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- This trial tests pacritinib, a multi-kinase inhibitor that targets CSF1R, IRAK1, JAK2, and FLT3, in adults and youths aged 12 years and older with myelodysplastic syndromes (MDS) or MDS/MPN. - It has two parts: Phase I in 12–17 year-olds to find a safe dose, and Phase II in adults 18+ to see if pacritinib helps, measured by overall response rate in two risk-based groups. - Eligible participants must have confirmed MDS or MDS/MPN and disease status defined by prior therapy resistance or ineligibility, depending on risk. - Key exclusions include active severe bleeding, uncontrolled infection, certain heart conditions or QT prolongation risk, pregnancy, and certain drug interactions.

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- This trial tests whether adding luspatercept to best supportive care can reduce the need for regular red blood cell transfusions in adults with anemia due to lower-risk MDS or non-proliferative MDS/MPN neoplasms. - It also aims to learn about the safety and tolerability of luspatercept in these patients. - Eligible participants are adults (18 or older) with MDS or non-proliferative MDS/MPN, certain splicing gene mutations, low marrow blasts, and who are refractory, intolerant to, or ineligible for prior ESA therapy and transfusion-dependent (average ≥2 units of RBCs every 8 weeks for at least 16 weeks). - The study excludes people who have had a stem cell transplant, certain del(5q) MDS without lenalidomide, uncontrolled hypertension, very low blood counts, active other cancers, or severe kidney or liver problems, as well as those who have had prior luspatercept or sotatercept, or who are pregnant. - Overall, researchers want to know if luspatercept can lessen transfusion needs while monitoring its safety in this specific MDS/MPN population.

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Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood is being studied. Conditions: aGVHD, Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia +1 • Eligibility: Inclusion Criteria: 1. Participants with the following hematologic malignancies: * Acute myelogenous leukemia (AML): High-risk AML including: * Antecedent hematological disease (e.g., myelodysplasia (MDS)) * Treatment-related * Complete…. Goal: The purpose of this study is to see if see if adding the specific combination of donors can result in acceptable levels of survival without evidence of disease. Phase/Status/Sponsor: Unknown phase; RECRUITING; Case Comprehensive Cancer Center.

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This is the Registry MDS, an observational study that follows patients with myelodysplastic syndromes (MDS) and therapy-related acute myeloid leukemia. It is currently recruiting and collects long-term data on diagnosis, medical history, laboratory results, and treatments from patients across 70 centers in France, with follow-up every six months. The goal is to learn how these diseases present and are managed over time and to understand care patterns and outcomes. Eligibility requires adults 18 or older with MDS or therapy-related AML who can give informed consent; those under 18 or unable to consent are excluded.

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Early Detection and Screening of Hematological Malignancies - SANGUINE is being studied. Conditions: Hematologic Malignancy • Eligibility: Inclusion Criteria: General criteria for all study populations: 1. Male and female subjects ≥18 years of age 2. Ability to understand and willingness to sign a written informed…. Goal: This is a multicenter, open-label, non-interventional controlled study to identify and characterize the epigenetic signatures for a set of hematological malignancies: Multiple myeloma (MM), pre-MM conditions \[smoldering MM (SMM) and monoclonal gammopathy of undetermined significance (MGUS)\], Hodgkin lymphoma (HL), diffuse large B cell lymphoma (DLBCL), Follicular lymphoma (FL), Marginal Zone lymphomas (MZL), acute myeloid leukemia (AML)\*, myelodysplastic syndrome (MDS), subjects at risk and control subjects with no malignant disease. \*Patients with a diagnosis of acute promyelocytic leukemia (APL) are not included Phase/Status/Sponsor: Unknown phase; RECRUITING; JaxBio Ltd.

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- This trial tests Monalizumab, an anti-NKG2A antibody, in adults with AML or MDS who are undergoing haploidentical stem cell transplantation with post-transplant cyclophosphamide. - It is a Phase II, non-randomized, open-label, single-center study enrolling about 18 participants. - Participants receive 1 mg/kg Monalizumab IV on day +30 and day +44 after transplant to see if it improves graft-versus-host disease–free and progression-free survival at 1 year, and to assess safety and NK cell function. - Key exclusions include being under 18, active uncontrolled infections, CNS AML involvement, pregnancy, rapid relapse before day 30, acute GVHD before day +30, or having had a second allogeneic transplant.

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A Study of MGD024 in Patients With Relapsed or Refractory Hematologic Malignancies is being studied. Conditions: Leukemia, Acute Myeloid, Myelodysplastic Syndromes, Classical Hodgkin Lymphoma +5 • Eligibility: Inclusion Criteria: * Adult patients at least 18 years of age, able to provide informed consent and willing to comply with all study procedures. * Participants with *…. Goal: CP-MGD024-01 is a Phase 1, open-label, multi-center study of MGD024 as a single agent in participants with select blood cancers that have not responded to treatment with standard therapies or who have relapsed after treatment. The study is designed to determine the safety, tolerability, pharmacokinetics (affect of the body on the drug), pharmacodynamic (affect of the drug on the body), immunogenicity (development of antibodies against the drug), and preliminary anti-cancer effect of MGD024. Phase/Status/Sponsor: Unknown phase; RECRUITING; MacroGenics.

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Myeloproliferative Neoplasms (MPNs) Patient Registry is being studied. Conditions: Primary Myelofibrosis, Polycythemia Vera, Essential Thrombocythemia +7 • Eligibility: Inclusion Criteria: Diagnosis of one of the following myeloproliferative neoplasms (MPNs): * Atypical CML (aCML) * Chronic eosinophilic leukemia-not otherwise specified (CEL, NOS), * Chronic myelomonocytic leukemia (CMML)…. Goal: The mandate of this MPN registry is to collect clinical information, including molecular results, from consenting patients with a variety of MPNs at different time points during the course of their disease. Phase/Status/Sponsor: Unknown phase; RECRUITING; University Health Network, Toronto.

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This trial is testing digital PCR to monitor measurable residual disease after allogeneic hematopoietic stem cell transplantation in people with leukemia, MDS, and related blood disorders, and it is currently recruiting. It aims to see if digital PCR can better detect MRD and predict relapse compared with standard methods like conventional qPCR or multicolor flow cytometry. Eligible participants must have had at least one fusion gene or tumor-associated mutation detected at diagnosis and must have neutrophil engraftment and have had at least one MRD test by digital PCR after transplant. Exclusions include patients who relapse or die before the first digital PCR test, and those with only DTA mutations (DNMT3A, TET2, ASXL1) or only germline mutations.

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- This study tests the long‑term safety of luspatercept in people who have already participated in other luspatercept trials. - It is for adults 18 and older who were in a parent luspatercept study and are either continuing treatment, crossing over from placebo, or entering long‑term follow‑up, and it uses Transition, Treatment, and Follow‑up phases plus a 42‑day safety check after the last dose. - Researchers will monitor safety and track overall survival every 6 months for at least 5 years from the first dose (or 3 years after the last dose, whichever comes later), and watch for progression to AML or other cancers. - Eligible participants must have been in the parent trial, sign informed consent, and meet visit requirements; females on treatment need pregnancy tests and contraception, while males must use a condom with pregnant partners or partners of childbearing potential. - Exclusions include pregnancy or breastfeeding, use of prohibited medications, significant medical or psychological conditions, or other factors that could interfere with safety or study data.

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This is a small, single-arm, open-label pilot trial testing an alternating low-dose schedule of 5-azacitidine and decitabine (5AZA-alt-DEC) for people with myelodysplastic syndromes (MDS) or MDS/MPN overlap disorders. It is for adults who may respond to hypomethylating agent therapy and have evidence of prior response to HMAs, and who meet safety and performance criteria. The study aims to learn how often patients have an overall response (complete, partial, or hematologic improvement), how long responses last, and the safety profile, with correlative lab studies to explore biology. Exclusions include very high-risk MDS by IPSS-R or prior azacitidine/decitabine therapy, pregnancy, uncontrolled illness, active HIV, and other factors that could affect safety or results.

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This trial tests adding Decitabine and Venetoclax to a reduced-intensity conditioning transplant using fludarabine and melphalan before an allogeneic stem cell transplant for people with high-risk AML and MDS. It is for adults aged 18–75 who have a related or unrelated stem cell donor and are eligible for reduced-intensity conditioning before transplant. The study aims to assess safety, tolerability, and preliminary activity of this drug combination, using a standard 3+3 design and monitoring dose-limiting toxicities through day 28 after the transplant. Key exclusions include prior autologous transplant within 3 months, prior allogeneic transplant, active HIV, pregnancy or breastfeeding, uncontrolled infection, cirrhosis, and known hypersensitivity to Decitabine, Venetoclax, or ATG.

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This trial tests onvansertib, a PLK1 inhibitor, in adults with recurrent or treatment-refractory chronic myelomonocytic leukemia (CMML) or MDS/MPN overlap neoplasms. It uses a dose-escalation design to find the right dose and then expands at that dose, with the drug given by mouth daily and ongoing bone marrow tests and ultrasound imaging. The study will assess safety and adverse events and look for signs of activity such as complete remission, overall remission, spleen response, and symptom changes. Eligible participants are adults with CMML or MDS/MPN overlap disease; key exclusions include progression to acute leukemia, active CNS disease, QT prolongation risk, pregnancy, and prior exposure to a PLK1 inhibitor.

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This is an observational, multicenter study to find out how common familial AML/MDS is among people with AML or MDS who have a relative with a hematologic cancer or an early-onset cancer (under 40). It includes adults diagnosed between 2014 and 2022 and uses both retrospective and prospective data, with no intervention. Each year, participating sites will be surveyed to count new AML/MDS diagnoses to estimate incidence, and participants will be followed through December 2023 for at least one year. The study aims to identify and describe patients with familial MDS/AML or signs of known hereditary susceptibility to AML/MDS; there are no listed exclusion criteria.

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Allo HSCT Using RIC and PTCy for Hematological Diseases is being studied. Conditions: Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Biphenotypic Acute Leukemia +15 • Eligibility: Inclusion Criteria: * Age 0 to 75 years of age with Karnofsky score ≥ 70% (≥ 16 years) or Lansky score ≥ 50 (\< 16 years). * 5/6…. Goal: This is a Phase II study following subjects proceeding with our Institutional non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen followed by a related, unrelated, or partially matched family donor stem cell infusion using post-transplant cyclophosphamide (PTCy), sirolimus and MMF GVHD prophylaxis. Phase/Status/Sponsor: Unknown phase; RECRUITING; Masonic Cancer Center, University of Minnesota.

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- The trial tests whether adding hyperbaric oxygen therapy around an allogeneic peripheral blood stem cell transplant is safe and whether it can improve engraftment and reduce complications like graft-versus-host disease, mucositis, infections, and neutrophil recovery. - It is for adults undergoing allogeneic PBSC transplant for certain myeloid cancers and disorders; there are two cohorts, but only the second cohort is currently recruiting. - The second cohort includes people with CMML, aCML, chronic monocytic leukemia, chronic neutrophilic leukemia, myelofibrosis, and MDS/MPN overlap syndrome. - Eligibility requires adults aged 18-75 with adequate organ function and performance status; key exclusions include pregnancy, severe lung disease needing oxygen, active infection, ear/sinus problems, claustrophobia, seizures, and ongoing tobacco use around transplant.

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- This phase II trial tests whether adding venetoclax to ASTX727 (decitabine plus cedazuridine) improves outcomes for bone marrow cancer in CMML and MDS/MPN with excess blasts compared with ASTX727 alone. - It is for adults with MDS/MPN overlap syndrome with at least 5% marrow blasts who meet certain health criteria. - Participants are randomly assigned to either ASTX727 plus venetoclax or ASTX727 alone, and the study looks at complete remission rates and other response and survival measures. - Key exclusions include pregnancy, uncontrolled central nervous system disease, significant cardiac disease, recent extensive prior MDS/MPN therapy, and other safety-related conditions (e.g., grapefruit product restrictions).

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This study tests a combination of guadecitabine (a chemotherapy) and atezolizumab (an immunotherapy) in adults with advanced myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) that has relapsed or is refractory to prior treatment, and it includes newly diagnosed MDS as well. It is a two-part study (phase I dose-escalation followed by phase II) to find a safe dose and then evaluate how well the combination works. The trial aims to assess safety and tolerability and to measure efficacy, including overall survival, duration of response, and changes in transfusion dependence. Eligibility requires prior treatment with azacitidine or decitabine with progression or loss of response, plus certain health criteria; key exclusions include active autoimmune disease, active infection, prior PD-1/PD-L1 or CTLA-4 therapy, and pregnancy. The study is currently active but not recruiting.

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- This study tests DFV890 as a single-agent treatment, using a dose-optimization part and a dose-expansion part in adults with myeloid diseases. - It targets very low, low, or intermediate risk MDS, very low/low/intermediate risk CMML, and high-risk CCUS. - The trial aims to learn about safety, tolerability, pharmacokinetics, pharmacodynamics, efficacy, and the best dose to use. - Key exclusions include recent systemic cancer therapy, hypersensitivity to DFV890, prior or concurrent use of drugs with the same mechanism, and certain drug interaction or metabolism issues (e.g., poor CYP2C9 metabolizers in expansion). - Participants will be treated for at least 24 weeks and must provide bone marrow samples at screening and at select timepoints.

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- This trial tests a prophylactic treatment after allogeneic stem cell transplantation to prevent relapse in adults with very high-risk MDS, identified by IPSS-M scoring. - It will measure relapse-free survival at 1 year and 2 years after transplant and compare results with historical data to see if the approach improves outcomes. - The study is for adults aged 18 to 70 with MDS who have a suitable stem cell donor (related donors: 5/10 HLA match or unrelated donors: 8/10) and adequate organ function and performance status. - Key exclusions include prior stem cell transplantation, ECOG > 2, HCT-CI ≥ 3, active infection or unstable disease, pregnancy or breastfeeding, HIV, active hepatitis B/C needing antiviral therapy, and allergy to the intervention drugs (e.g., azacitidine, decitabine, venetoclax).

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This trial tests BTX-A51 capsules in adults with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) to assess safety, how the drug acts in the body, and early signs of effectiveness. It is an open-label, dose-escalation study with three parts to find the maximum tolerated dose and the recommended phase 2 dose, and to explore a combination with azacitidine. Participants are adults (18+) who have exhausted standard treatments and have adequate organ function and performance status. Key exclusions include acute promyelocytic leukemia, very high white blood cell count, recent chemotherapy, recent stem cell transplant with active GVHD or systemic immunosuppression, active infections, significant heart disease, conditions affecting oral drug absorption, and pregnancy.

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Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC is being studied. Conditions: Lung Neoplasms, Myeloid-Derived Suppressor Cells, Immunosuppression • Eligibility: Inclusion Criteria: * consecutive patients * lung carcinoma surgically treated by surgery only Exclusion Criteria: * patient receiving chemotherapy, radiotherapy or immunotherapy in the neoadjuvant setting (all objectives)…. Goal: Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to cellular and soluble immunosuppressive mechanisms. MDSC are one of the most important immunosuppressive cells, that also harbour non immunologic functions, favouring cancer invasion. Phase/Status/Sponsor: Unknown phase; NOT_YET_RECRUITING; University Hospital, Bordeaux.

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- This trial tests whether adding luspatercept to azacitidine improves outcomes compared with azacitidine alone in adults with untreated higher-risk MDS. - It is a randomized, prospective, single-center, open-label study conducted at Peking Union Medical College Hospital. - It is for adults 18 or older with untreated higher-risk MDS and meets specific health criteria (e.g., adequate liver/kidney function, ECOG 0-2, expected survival >6 months). - Key exclusions include active infection, other cancers, significant liver or kidney dysfunction, prior bone marrow transplant, pregnancy or lactation, and allergies to azacitidine or excipients. - The study aims to determine which treatment approach provides better efficacy in this patient group (AZA plus luspatercept vs AZA alone).

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Haploidentical Hematopoietic Cell Transplantation Using TCR Alpha/Beta and CD19 Depletion is being studied. Conditions: Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia in Remission, Myelodysplastic Syndromes +8 • Eligibility: Inclusion Criteria: 1. Lack of suitable conventional donor (10/10 HLA matched related or unrelated donor) or presence of rapidly progressive disease not permitting time to identify an HLA-matched…. Goal: Patients with medical conditions requiring allogeneic hematopoietic cell transplantation (allo-HCT) are at risk of developing a condition called graft versus host disease (GvHD) which carries a high morbidity and mortality. This is a phase I/II study that will test the safety and efficacy of hematopoietic cell transplantation (HCT) with ex-vivo T cell receptor Alpha/Beta+ and CD19 depletion to treat patients' underlying condition. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Baylor College of Medicine.

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This study tests using ultrasound to detect splenomegaly in adults with isolated thrombocytopenia. It aims to find how common splenomegaly is in these patients and how it relates to symptoms, complications, treatment response, and overall disease outcomes. It also seeks to explain possible causes of splenomegaly in this setting. Eligible participants are adults over 18 with isolated thrombocytopenia due to conditions such as primary immune thrombocytopenic purpura, amegakaryocytic aplasia, certain megakaryocyte dysplasia–type myelodysplastic syndromes, lymphoproliferative disorders with secondary ITP, or autoimmune diseases with secondary ITP, who are willing to participate and either admitted or followed in hematology outpatient clinics. The study is not yet recruiting, and key exclusions include EDTA-induced pseudothrombocytopenia, platelet satellitism, drug-induced thrombocytopenia, heparin-induced thrombocytopenia/thrombosis syndrome, post-transfusion purpura, DIC, pregnancy, and patients under 18 or with bicytopenia/pancytopenia.

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- This trial tests whether itacitinib, an immune-suppressing anti-inflammatory drug, given around a non‑myeloablative haploidentical peripheral blood stem cell transplant with high-dose posttransplant cyclophosphamide, can help older patients. - Researchers want to know if itacitinib can prevent severe cytokine release syndrome after transplant, reduce graft-versus-host disease, and possibly shorten the time patients need other immune-suppressing drugs. - Participants are people aged 60 and older with certain blood cancers who have a related, partially matched donor. - Key exclusions include active CNS leukemia, HIV, active HBV or HCV requiring treatment, pregnancy, and prior/allogeneic transplant or uncontrolled infection.

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- This is a phase 1, open-label study testing an oral drug called LY3410738, which targets IDH1 and IDH2 mutations in adults with advanced blood cancers. - The study has two parts: dose escalation to find the maximum tolerated dose, followed by dose expansion to further assess safety and signs of activity in five cohorts. - Eligible participants include people with IDH-mutant advanced hematologic malignancies who have received prior therapy; in some arms, older AML patients or relapsed/refractory AML patients (US only) may enroll. - Key exclusions include active infection or active CNS disease, recent stem cell transplant or CAR-T therapy, pregnancy, and certain drug interactions or other serious conditions.

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CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant is being studied. Conditions: Chronic Myeloid Leukemia (CML), Acute Myelogenous Leukemia (AML), Myelodysplastic Syndrome (MDS) +3 • Eligibility: Inclusion Criteria: General Eligibility (All Patients) * Must be \< 22 years of age * Diagnosed with a malignant disease * Must be fully informed about their illness…. Goal: The purpose of this study is to learn more about the effects of (classification determinant) CD34+ stem cell selection on graft versus host disease (GVHD) in children, adolescents, and young adults. CD34+ stem cells are the cells that make all the types of blood cells in the body. Phase/Status/Sponsor: Unknown phase; ACTIVE_NOT_RECRUITING; Diane George.

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This study tests how luspatercept is used and what outcomes occur in adults with lower-risk myelodysplastic syndromes (LR-MDS) in China. It includes adults 18 and older who have no del(5q) MDS, are ESA-naïve, and have received at least two cycles of luspatercept as monotherapy. The goal is to describe treatment patterns and clinical outcomes after starting luspatercept and to note the patients’ anemia history before treatment. Exclusions include a history of acute myeloid leukemia before MDS diagnosis or having had a stem cell transplant prior to starting luspatercept.

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The study is testing adding Ivosidenib for IDH1 mutations or Enasidenib for IDH2 mutations to standard chemotherapy in adults with newly diagnosed AML or MDS-EB2 who are candidates for intensive chemotherapy. It uses induction therapy, followed by consolidation therapy and then maintenance therapy, to see if the combination can control the disease more effectively and for a longer time. The trial is currently active but not recruiting. Key exclusions include prior chemotherapy for AML/MDS-EB2 (except certain agents), having both IDH1 and IDH2 mutations, APL, active infection, significant heart disease, and pregnancy or contraception requirements for participants.

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A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologic Malignancies is being studied. Conditions: Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL) +9 • Eligibility: Inclusion Criteria: * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures * Histologically or cytologically confirmed diagnosis…. Goal: This is a Phase 1 dose-escalation study of PRT2527, a potent and highly selective cyclin-dependent kinase (CDK) 9 inhibitor, in participants with select relapsed or refractory (R/R) hematologic malignancies. The purpose of this study is to evaluate the safety, tolerability, recommended phase 2 dose (PR2D), and preliminary efficacy of PRT2527 as a monotherapy and in combination with zanubrutinib or venetoclax. Phase/Status/Sponsor: Unknown phase; COMPLETED; Prelude Therapeutics.

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Evaluation of IPI-549 Combined With Front-line Treatments in Pts. With Triple-Negative Breast Cancer or Renal Cell Carcinoma is being studied. Conditions: Breast Cancer, Renal Cell Carcinoma • Eligibility: Inclusion Criteria: 1. ≥18 years of age. 2. Have signed and dated an independent review board (IRB)/independent ethics committee (IEC) approved informed consent form (ICF) in accordance with…. Goal: MARIO-3 is a Phase 2 multi-arm combination cohort study designed to evaluate IPI-549, Infinity Pharmaceutical's first-in-class, oral immuno-oncology product candidate targeting immune-suppressive tumor-associated myeloid cells through selective inhibition of phosphoinositide-3-kinase (PI3K)-gamma, in combinations with Tecentriq and Abraxane (nab-paclitaxel) in front-line triple negative breast cancer (TNBC) and in combination with Tecentriq and Avastin (bevacizumab) in front-line renal cell cancer (RCC). Phase/Status/Sponsor: Unknown phase; UNKNOWN; Infinity Pharmaceuticals, Inc..

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Tissue Study of Bv8/PK-2 Inhibition in Human Cancer is being studied. Conditions: Cancer • Eligibility: Inclusion Criteria: * ages 18-85 years * Pathologically-confirmed diagnosis of pancreatic ductal adenocarcinoma undergoing surgical pancreaticoduodenectomy Exclusion Criteria: * refuse to take part * preoperative chemotherapy. Goal: Study hypothesis is that inhibition of Bv8 production in bone marrow cells of a mice wil reduce the rate of growth of a primary human tumor implanted in the mice. we will take mice and transform their bone marrow cells into non-Bv8 producing cells. Phase/Status/Sponsor: Unknown phase; UNKNOWN; Rambam Health Care Campus.

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INCB018424 in Patients With Advanced Hematologic Malignancies is being studied. Conditions: Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome +1 • Eligibility: Inclusion Criteria: 1. Must be at least 18 years of age. 2. Patients must have relapsed/refractory leukemias for which no standard therapies exist. Patients with poor-risk myelodysplasia (MDS)…. Goal: The goal of this clinical research study is to learn if ruxolitinib can help to control advanced hematological malignancies. The safety of this drug will also be studied. Phase/Status/Sponsor: Unknown phase; COMPLETED; M.D. Anderson Cancer Center.

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Myeloablative Hematopoietic Progenitor Cell Transplantation (HPCT) for Pediatric Malignancies is being studied. Conditions: Leukemia, Myelogenous, Chronic, Leukemia, Lymphoblastic, Acute, Leukemia, Myelogenous, Acute +2 • Eligibility: Inclusion Criteria: * Malignant Disease * Chronic myleogenous leukemia in chronic or accelerated phase * Acute lymphoblastic leukemia (ALL) * First remission high-risk ALL (Ph+, t( 4-11) infants).…. Goal: The purpose of this study is to show that myeloablative hematopoietic progenitor cell transplantation (HPCT) continues to offer acceptable disease-free survival for select patients requiring HPCT. Phase/Status/Sponsor: Unknown phase; COMPLETED; Ann & Robert H Lurie Children's Hospital of Chicago.

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A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving is being studied. Conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome +1 • Eligibility: Inclusion Criteria: 1. Male and female patients aged ≥ 18 years. 2. Patients with relapsed /refractory AML, ALL, or MLL with rearrangement of the MLL gene, including 11q23…. Goal: The purpose of this study is to determine the safe dose of EPZ-5676, to evaluate the safety of EPZ-5676 in patients with advanced hematologic malignancies, and to conduct a preliminary assessment of the anti-leukemia activity of EPZ-5676 in patients with acute leukemias bearing rearrangements of the MLL gene. Currently this study is in the MLL-r restricted/expansion phase and is only enrolling patients with rearrangements involving the MLL gene, including 11q23 or partial tandem duplications (PTD). Phase/Status/Sponsor: Unknown phase; COMPLETED; Epizyme, Inc..

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CD8+ Memory T-Cells as Consolidative Therapy After Donor Non-myeloablative Hematopoietic Cell Transplant in Treating Patients With Leukemia or Lymphoma is being studied. Conditions: Acute Myeloid Leukemia, B-Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia +4 • Eligibility: Inclusion Criteria: * Must have a human leukocyte antigen (HLA)-matched or single allele-mismatched adult sibling serving as donor * Must have a myeloid or lymphoid malignant disease that…. Goal: This phase 2 trial studies how well cluster of differentiation 8 (CD8)+ memory T-cells work as a consolidative therapy following a donor non-myeloablative hematopoietic cell transplant in treating patients with leukemia or lymphoma. Giving total lymphoid irradiation and anti-thymocyte globulin before a donor hematopoietic cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Phase/Status/Sponsor: Unknown phase; COMPLETED; Robert Lowsky.

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Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults is being studied. Conditions: Chronic Lymphocytic Leukemia, Graft vs Host Disease, Leukemia +2 • Eligibility: * INCLUSION CRITERIA - PATIENT: Ages 55-71 years. Chronic myelogenous leukemia (CML): chronic phase. Acute lymphoblastic leukemia (ALL), all patients in complete or partial remission. Acute myelogenous leukemia…. Goal: Diseases such as leukemia, lymphoma, and multiple myeloma fall into the category of blood cancers. Some of these conditions can now be cured by bone marrow transplantation (BMT). Phase/Status/Sponsor: Unknown phase; COMPLETED; National Heart, Lung, and Blood Institute (NHLBI).

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Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer is being studied. Conditions: Chronic Myeloproliferative Disorders, Leukemia, Lymphoma +4 • Eligibility: DISEASE CHARACTERISTICS: * Diagnosis of a hematologic malignancy of 1 of the following high-risk types: * Acute lymphoblastic leukemia * Acute myeloid leukemia * Chronic myelogenous leukemia *…. Goal: RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. Phase/Status/Sponsor: Unknown phase; COMPLETED; OHSU Knight Cancer Institute.

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Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors is being studied. Conditions: Leukemia, Lymphoma, Myelodysplastic Syndrome • Eligibility: Inclusion Criteria: * Histologically or cytologically confirmed advanced and/or aggressive hematologic malignancy (including myelodysplastic syndrome) that is unlikely to be cured by alternative therapies * HLA-Matched unrelated donor;…. Goal: A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. Phase/Status/Sponsor: Unknown phase; COMPLETED; Dana-Farber Cancer Institute.

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Belinostat and Bortezomib in Treating Patients With Relapsed or Refractory Acute Leukemia or Myelodysplastic Syndrome is being studied. Conditions: Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome +1 • Eligibility: Inclusion * Relapsed or refractory acute leukemia * acute myeloid leukemia (AML) other than APL * acute lymphocytic leukemia (ALL) * acute leukemia that has evolved from a…. Goal: RATIONALE: Belinostat and bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving belinostat together with bortezomib may kill more cancer cells. Phase/Status/Sponsor: Unknown phase; COMPLETED; Virginia Commonwealth University.

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Perifosine in Treating Patients With Refractory Solid Tumors or Hematologic Cancer is being studied. Conditions: Leukemia, Lymphoma, Myelodysplastic Syndromes +2 • Eligibility: DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor, non-Hodgkin's lymphoma, chronic lymphocytic leukemia, myelodysplastic syndromes, or Hodgkin's lymphoma that has no effective standard therapeutic option but requires systemic therapy…. Goal: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of perifosine in treating patients who have refractory solid tumors or hematologic cancer. Phase/Status/Sponsor: Unknown phase; COMPLETED; National Cancer Institute (NCI).

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Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain is being studied. Conditions: Cancer • Eligibility: Inclusion Criteria: * Male or female, ≥ 18 years of age. * Diagnosis of cancer. * Opioid-tolerant. Subjects who were opioid tolerant were those taking ≥ 60 mg…. Goal: This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain. The study medication is administered under the tongue as a simple spray and can be self-administered by patients or assisted by their caregivers. Phase/Status/Sponsor: Unknown phase; COMPLETED; INSYS Therapeutics Inc.

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Cyproheptadine and Megestrol in Preventing Weight Loss in Children With Cachexia Caused By Cancer or Cancer Treatment is being studied. Conditions: Brain Tumor, Central Nervous System Tumors, Cachexia +5 • Eligibility: INCLUSION CRITERIA: * Any cachectic patient with weight loss presumed secondary to cancer or cancer related therapy is eligible. Cachexia is defined as having one or more of…. Goal: RATIONALE: Cyproheptadine and megestrol may improve appetite and help prevent weight loss in children with cancer. PURPOSE: This phase II trial is studying how well cyproheptadine and megestrol work in improving appetite and preventing weight loss in children with cachexia caused by cancer or cancer treatment. Phase/Status/Sponsor: Unknown phase; COMPLETED; University of South Florida.

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Pyroxamide in Treating Patients With Advanced Cancer is being studied. Conditions: Chronic Myeloproliferative Disorders, Leukemia, Lymphoma +5 • Eligibility: DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed solid tumor or hematologic malignancy * Disease that has failed standard therapies (e.g., surgery, radiotherapy, endocrine therapy, or chemotherapy) or for…. Goal: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer. Phase/Status/Sponsor: Unknown phase; COMPLETED; Memorial Sloan Kettering Cancer Center.

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Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Refractory Cancer is being studied. Conditions: Chronic Myeloproliferative Disorders, Leukemia, Lymphoma +4 • Eligibility: DISEASE CHARACTERISTICS: Histologically confirmed malignancy Malignant lymphoma - Non-Hodgkin's lymphoma Intermediate and high grade (aggressive) histology with primary refractory disease or relapsed following standard therapy - Hodgkin's disease…. Goal: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Phase/Status/Sponsor: Unknown phase; COMPLETED; Cancer Treatment Centers of America.

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Combination Chemotherapy Followed by Bone Marrow Transplantation in Treating Patients With Advanced Hematologic Cancer is being studied. Conditions: Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes +1 • Eligibility: DISEASE CHARACTERISTICS: * Diagnosis of one of the following: * Infant leukemia * Acute lymphoblastic leukemia in 3rd or greater remission or relapse * Undifferentiated or biphenotypic leukemia…. Goal: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Phase/Status/Sponsor: Unknown phase; COMPLETED; Memorial Sloan Kettering Cancer Center.

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Tipifarnib in Treating Patients With Advanced Hematologic Cancer is being studied. Conditions: Chronic Myeloproliferative Disorders, Leukemia, Lymphoma +2 • Eligibility: DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed hematologic malignancy refractory to standard therapy or for which no known effective therapy exists * Hodgkin's or non-Hodgkin's lymphoma * Known…. Goal: Randomized phase I trial to study the effectiveness of tipifarnib in treating patients who have advanced hematologic cancer. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase/Status/Sponsor: Unknown phase; COMPLETED; National Cancer Institute (NCI).

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Sirolimus With Tacrolimus for Graft-vs-Host Disease Prophylaxis After Un-Related Stem Cell Transplantation is being studied. Conditions: Acute Myelogenous Leukemia, Graft Versus Host Disease, Acute Lymphoblastic Leukemia +4 • Eligibility: Inclusion Criteria: * Acute myelogenous leukemia(AML) in first or subsequent remission, in untreated first relapse or any treated relapse. * Acute lymphoblastic leukemia(ALL) in first or subsequent remission,…. Goal: The purpose of this study is to evaluate the ability of sirolimus to prevent graft versus host disease (GVHD) in patients following stem cell transplant from an unrelated donor. This trial is designed to test the hypothesis that elimination of methotrexate in the unrelated donor group would lead to less transplant-related toxicity while still preserving the effective control of GVHD. Phase/Status/Sponsor: Unknown phase; COMPLETED; Dana-Farber Cancer Institute.

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Cellular Adoptive Immunotherapy in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndromes That Relapsed After Donor Stem Cell Transplant is being studied. Conditions: Leukemia, Myelodysplastic Syndromes • Eligibility: DISEASE CHARACTERISTICS: * Undergoing allogeneic hematopoietic stem cell transplantation\* from a major histocompatability complex (MHC)-identical related donor for 1 of the following: * Primary refractory acute myelogenous leukemia…. Goal: RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop cancer cells from growing. PURPOSE: This phase I trial is studying the side effects of cellular adoptive immunotherapy in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes that relapsed after donor stem cell transplant. Phase/Status/Sponsor: Unknown phase; COMPLETED; Fred Hutchinson Cancer Center.

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Health Care Coach Support in Reducing Acute Care Use and Cost in Patients With Cancer is being studied. Conditions: Acute Myeloid Leukemia, Brain Glioblastoma, Estrogen Receptor Negative +64 • Eligibility: Inclusion Criteria: * Newly diagnosed patients for the following conditions * Colon cancer stage III and IV * Rectal cancer stage II, III, IV * Glioblastoma multiforme (brain)…. Goal: This randomized pilot clinical trial studies health care coach support in reducing acute care use and cost in patients with cancer. Health care coach support may help cancer patients to make decisions about their care that matches what is important to them with symptom management. Phase/Status/Sponsor: Unknown phase; COMPLETED; Stanford University.

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CD34 Selected Allogeneic HCT w/ Myeloablative Conditioning Plus CD8+ Memory TCell Infusion in MDS, AL and CML is being studied. Conditions: Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes +2 • Eligibility: Recipient Inclusion Criteria: * Acute leukemia, in morphologic complete remission, OR myelodysplasia with \< 10% blasts in the marrow, and no circulating blasts that contain auer rods. Patients…. Goal: This study will evaluate combining stem cells from the patient's matched sibling donor (a standard CD34-selected transplant) with a second infusion of white blood cells called "CD8 memory T-cells" from their sibling donor. Phase/Status/Sponsor: Unknown phase; COMPLETED; Robert Lowsky.

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Electrophysiological Biomarkers of Chemotherapy-related Cognitive Impairment and Recovery is being studied. Conditions: Myelodysplastic Syndrome, Effects of Chemotherapy, Mild Cognitive Impairment +6 • Eligibility: Inclusion criteria: * HM diagnosis * scheduled to receive treatment based on risk classification * between 19 to 80 years of age- * normal or corrected-to-normal vision *…. Goal: Broadly speaking, the goal of this study is to better understand the influence of chemotherapy treatment on the cognitive and neural mechanisms underlying human behavior. Extant literature lacks diversity in studied cancer populations and treatment protocols, and provides limited understanding of the cognitive abilities that are impaired by chemotherapy. Phase/Status/Sponsor: Unknown phase; COMPLETED; University of Nebraska.

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Alemtuzumab, Fludarabine Phosphate, and Low-Dose Total Body Irradiation Before Donor Stem Cell Transplantation in Treating Patients With Hematological Malignancies is being studied. Conditions: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) +97 • Eligibility: Inclusion Criteria: * Patients must be not eligible for conventional transplants and must have disease expected to be stable for at least 100 days without chemotherapy; patients with…. Goal: This phase II trial studies the side effects and the best dose of alemtuzumab when given together with fludarabine phosphate and low-dose total body irradiation (TBI) and how well it works before donor stem cell transplant in treating patients with hematological malignancies. Giving chemotherapy and low-dose TBI before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. Phase/Status/Sponsor: Unknown phase; COMPLETED; Fred Hutchinson Cancer Center.

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High-Dose Busulfan and High-Dose Cyclophosphamide Followed By Donor Bone Marrow Transplant in Treating Patients With Leukemia, Myelodysplastic Syndrome, Multiple Myeloma, or Recurrent Hodgkin or Non-Hodgkin Lymphoma is being studied. Conditions: Accelerated Phase Chronic Myelogenous Leukemia, Adult Acute Lymphoblastic Leukemia in Remission, Adult Acute Megakaryoblastic Leukemia (M7) +70 • Eligibility: Criteria * Acute non-lymphocytic leukemia (FAB types M1-M7) in first, or second remission, or early first or second bone or marrow relapse (\>31% marrow blasts and no circulating…. Goal: RATIONALE: Giving high doses of chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. Phase/Status/Sponsor: Unknown phase; COMPLETED; Case Comprehensive Cancer Center.

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This trial tests an oral drug called LP-118 in adults whose blood cancers have relapsed or are refractory, and it plans to enroll up to 100 participants. It is a Phase 1 study with dose-escalation (Phase 1a) and expansion (Phase 1b) to assess safety, tolerability, and how the drug behaves in the body. It aims to find the maximum tolerated dose or the recommended dose for future studies and to gather early signs of activity across several relapsed/refractory blood cancers, including CLL/SLL, AML, NHL, MM, and ALL. Key exclusions include recent stem cell transplant or active GVHD, uncontrolled infections, significant heart problems or QT prolongation, pregnancy, and the inability to take oral medication. The study is sponsored by Newave Pharmaceutical Inc and is currently recruiting at multiple centers.

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RTA 408 Capsules in Patients With Melanoma - REVEAL is being studied. Conditions: Melanoma, Unresectable (Stage III) Melanoma, Metastatic (Stage IV) Melanoma • Eligibility: Inclusion Criteria: 1. Be ≥18 years of age; 2. Have advanced, unresectable (Stage III) or metastatic (Stage IV) melanoma; 3. Be eligible for commercial receipt of therapy to…. Goal: Malignant melanoma is a leading cause of death from cutaneous malignancies, accounting for approximately three-fourths of all skin cancer deaths. For metastatic or unresectable melanomas, standard treatment options include immune checkpoint inhibitors (e.g., ipilimumab and nivolumab) and other therapies, however, approved therapies are rarely curative. Phase/Status/Sponsor: Unknown phase; COMPLETED; Biogen.

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Investigating the Clinical Utility of the MDS is being studied. Conditions: Skin Lesion, Melanoma, Moles • Eligibility: Inclusion Criteria: 1. Lesion has one or more of the ABCDE features and is recommended for excision. 2. Lesion has at least 1 cm of skin around it…. Goal: The purpose of this study is to establish the clinical utility of the Melanoma Detection System (MDS). Phase/Status/Sponsor: Unknown phase; COMPLETED; Orlucent, Inc.

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VIDAZA-DLI Pre-emptive Azacitidine and Donor Lymphocyte Infusions Following Allogeneic Hematopoietic Stem Cell Transplantation for High Risk Acute Myeloid Leukemia and Myelodysplastic Syndrome is being studied. Conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome • Eligibility: Inclusion Criteria: * Patients with high risk acute myeloid leukemia undergoing allogeneic transplantation with either a familial or an unrelated donor. High risk AML is defined as :…. Goal: Patients included in the study with high risk acute myeloid leukemia or myelodysplastic syndrome as defined will receive an allogeneic transplantation conditioned by either myeloablative or reduced regimen. Following allogeneic transplantation, patients will receive a maintenance regimen combining chemotherapy with azacitidine (aza) and immunotherapy with donor lymphocyte infusion. Phase/Status/Sponsor: Unknown phase; COMPLETED; Nantes University Hospital.

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Blood Samples to Evaluate Biomarkers of Donor Chimerism is being studied. Conditions: Leukemia, Hodgkins Disease, Non-hodgkins Lymphoma +1 • Eligibility: Inclusion Criteria: * Diagnosed with a hematologic disease or malignancy * Scheduled to receive nonablative conditioning with fludarabine and total body irradiation * Donor is well-matched by high…. Goal: We are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. We will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body. Phase/Status/Sponsor: Unknown phase; COMPLETED; Fred Hutchinson Cancer Center.

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Use of T-allo10 in Hematopoietic Stem Cell Transplantation (HSCT) for Blood Disorders is being studied. Conditions: AML - Acute Myeloid Leukemia, MDS (Myelodysplastic Syndrome), Mixed Phenotype Acute Leukemia +3 • Eligibility: Inclusion Criteria: 1. Eligible diseases include: A. Acute Lymphoblastic Leukemia (B- or T-ALL) 1. Complete Response (CR)1-ultra high risk features * Unfavorable cytogenetics * Hypodiploidy * Induction failure…. Goal: A significant number of patients with hematologic malignancies need a hematopoietic stem cell transplant (HSCT) to be cured. Only about 50% of these patients have a fully matched donor, the remaining patients will require an HSCT from a mismatched related or unrelated donor. Phase/Status/Sponsor: Unknown phase; TERMINATED; Roncarolo, Maria Grazia, MD.

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Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections is being studied. Conditions: Chronic Lymphocytic Leukemia, CML (Chronic Myelogenous Leukemia), MDS (Myelodysplastic Syndrome) +2 • Eligibility: * INCLUSION CRITERIA: Recipient * Ages 18-75 years inclusive * Patients with hematologic malignancies who have signed consent for NHLBI transplant protocol 13-H-0144. * Susceptible to CMV reactivation…. Goal: Allogeneic hematopoetic stem cell transplantation (SCT) is frequently complicated by life threatening viral reactivation. Conventional antiviral therapy is suboptimal for cytomegalovirus (CMV), adenovirus (AdV) and Epstein-Barr virus (EBV) and nonexistent for BK virus (BKV). Phase/Status/Sponsor: Unknown phase; TERMINATED; National Heart, Lung, and Blood Institute (NHLBI).

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Alemtuzumab, Busulfan, and Cyclophosphamide Followed By a Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer is being studied. Conditions: Graft Versus Host Disease, Leukemia, Myelodysplastic Syndromes +1 • Eligibility: DISEASE CHARACTERISTICS: * Confirmed diagnosis of one of the following: * Primary acute myeloid leukemia (AML) meeting any of the following criteria: * First complete remission (CR; defined…. Goal: RATIONALE: Monoclonal antibodies, such as alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving chemotherapy drugs, such as busulfan and cyclophosphamide, before a donor stem cell transplant helps stop the growth of cancer cells. Phase/Status/Sponsor: Unknown phase; TERMINATED; Fred Hutchinson Cancer Center.

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Blood Samples From Patients on a Clinical Trial to CINV During HSCT is being studied. Conditions: Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor +9 • Eligibility: DISEASE CHARACTERISTICS: * Previously collected serum samples from patients with cancer enrolled on the placebo arm of the pilot aprepitant study * Patients treated with busulfan/cyclophosphamide or cyclophosphamide/total…. Goal: RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about nausea and vomiting caused by cancer treatment. PURPOSE: This laboratory study is looking at blood samples from patients with cancer who were treated on a clinical trial to control nausea and vomiting during donor stem cell transplant. Phase/Status/Sponsor: Unknown phase; TERMINATED; OHSU Knight Cancer Institute.

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Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation is being studied. Conditions: Leukemia, Lymphoma, Hodgkin's Disease +3 • Eligibility: Inclusion Criteria: One of these diagnoses: * Acute myeloid leukemia in complete or partial remission * Acute lymphocytic leukemia in complete or partial remission * Chronic myeloid leukemia…. Goal: This study tests the hypothesis that a purely immunosuppressive preparative regimen allows engraftment of related or unrelated allogeneic hematopoietic stem cells in subjects with high-risk malignancies, without causing the post-transplant myelosuppression (e.g., neutropenia, thrombocytopenia) that occurs with currently used reduced-intensity (nonmyeloablative) preparative regimens. This study incorporates both safety and efficacy endpoints and evaluates a novel preparative regimen of alemtuzumab plus continuous-infusion pentostatin, two immunosuppressive agents with different mechanisms of action, in recipients of related or unrelated allogeneic hematopoietic stem cell transplantation. Phase/Status/Sponsor: Unknown phase; TERMINATED; University of Arizona.

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Fludarabine, Cyclophosphamide, and Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients Who Are Undergoing a Donor Umbilical Cord Blood Transplant for Hematologic Cancer is being studied. Conditions: Chronic Myeloproliferative Disorders, Graft Versus Host Disease, Leukemia +4 • Eligibility: DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following hematologic malignancies: * Acute myeloid leukemia (AML) with or without history of myelodysplastic syndromes, meeting 1 of the following…. Goal: RATIONALE: Giving low doses of chemotherapy, such as fludarabine and cyclophosphamide, and radiation therapy before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. Phase/Status/Sponsor: Unknown phase; TERMINATED; University of Rochester.

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Study Evaluating the Tolerance and Biological Activity of Oral Clioquinol in Patients With Relapsed or Refractory Hematological Malignancy is being studied. Conditions: Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia +4 • Eligibility: Inclusion Criteria: 1. Relapsed or refractory acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic lymphocytic leukemia (CLL), high risk myelodysplasia (MDS) with an IPSS score \> 2.5,…. Goal: This is an open-label, single arm phase 1 study to evaluate the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of Clioquinol in patients with relapsed or refractory hematologic malignancies. The study will also characterize Cliquinol's safety, tolerability and pharmacodynamic effect. Phase/Status/Sponsor: Unknown phase; TERMINATED; University Health Network, Toronto.

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Presence of Donor-Derived DNA in Semen Samples From Cancer Survivors Who Underwent Donor Stem Cell Transplant is being studied. Conditions: Cancer Survivor, Chronic Myeloproliferative Disorders, Leukemia +6 • Eligibility: DISEASE CHARACTERISTICS: * Disease in remission * More than 365 days since prior allogeneic hematopoietic stem cell transplantation with history of full donor engraftment * Stable complete donor…. Goal: RATIONALE: Studying samples of semen from cancer survivors in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This phase I research study is looking at the presence of donor-derived DNA in semen samples form cancer survivors who underwent donor stem cell transplant. Phase/Status/Sponsor: Unknown phase; TERMINATED; Vanderbilt University.

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Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Stem Cell Transplant in Treating Patients With Myeloproliferative Disorder, MS, AML, or CML is being studied. Conditions: Chronic Myeloproliferative Disorders, Leukemia, Myelodysplastic Syndromes • Eligibility: INCLUSION CRITERIA: * Myelodysplastic syndrome with IPSS score \> 0.(Appendix B) Or * Myeloproliferative disorders * Primary Myelofibrosis with Lile score of 1 or 2 (Appendix C) *…. Goal: Patients are being asked to participate in this study because they have a malignant blood disease such as Myelodysplastic Syndrome (MDS), Myeloproliferative Disorder (MPD), Acute Myelogenous Leukemia (AML) or Chronic Myelogenous Leukemia (CML). We feel that patients could benefit from an allogeneic (meaning the cells come from a donor other than themself) stem cell transplant. Phase/Status/Sponsor: Unknown phase; TERMINATED; Baylor College of Medicine.

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Phase II Cont. IV of ON 01910.Na in MDS w/ Trisomy 8/Intermed-1, 2/High Risk is being studied. Conditions: Myelodysplastic Syndromes • Eligibility: Inclusion Criteria: * Diagnosis of IPSS Intermediate or High risk MDS by bone marrow biopsy, marrow cytogenetics and blood counts, using FAB morphologic criteria * Eastern Cooperative Oncology…. Goal: This study is under Molecular and Cellular Characterization of Myelodysplastic Syndromes (MDS) (eProtocol 15369). The purpose of this proposed study is to analyze existing samples taken from participants participating in a clinical trial evaluating the efficacy and safety of investigational agent ON 01910.Na (eProtocol 16214). Phase/Status/Sponsor: Unknown phase; COMPLETED; Peter L Greenberg.

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Brentuximab Vedotin Prevention of (GVHD) After Unrelated Allogeneic Stem Cell Transplantation is being studied. Conditions: Leukemia, Acute Myeloid, Leukemia, Lymphoblastic,Acute, Myelodysplastic Syndromes • Eligibility: Inclusion Criteria: * Patient must be scheduled to undergo stem cell transplantation for one of the following diagnoses: * acute myeloid leukemia (AML) in CR1 (first complete remission,…. Goal: This pilot clinical trial studies the safety and maximum tolerated dose of brentuximab vedotin when given with tacrolimus and methotrexate after unrelated allogeneic donor stem cell transplant in patients with acute myeloid leukemia, acute lymphoblastic leukemia, or myelodysplastic syndromes. The addition of brentuximab vedotin to tacrolimus and methotrexate may result in a significant reduction of graft versus host disease in these patients. Phase/Status/Sponsor: Unknown phase; COMPLETED; Washington University School of Medicine.

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Dasatinib for Immune Modulation After Donor Stem Cell Transplant for Hematologic Malignancies is being studied. Conditions: Non-Hodgkin's Lymphoma, Hodgkin's Lymphoma, Myeloid Leukemia +3 • Eligibility: Inclusion Criteria: * Recipients of first ASCT from related or unrelated donor for the treatment of hematologic malignancies (acute myeloid leukemia, chronic myeloid leukemia, acute lymphoblastic leukemia, chronic…. Goal: This study uses a drug called dasatinib to produce an anti-cancer effect called large granular lymphocyte cellular expansion. Large granular lymphocytes are blood cells known as natural killer cells that remove cancer cells. Phase/Status/Sponsor: Unknown phase; TERMINATED; Barbara Ann Karmanos Cancer Institute.

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StemRegenin-1 Expanded vs Unexpanded UCB for High Risk Heme Malignancies is being studied. Conditions: Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia +1 • Eligibility: Inclusion Criteria: * Must have a partially HLA matched UCB unit with a pre-cryopreserved TNC dose \>2.5 x 107 per kilogram recipient weight. HLA matching is initially based…. Goal: This is an open label, interventional, randomized phase II trial comparing StemRegenin-1 (SR-1) cultured umbilical cord blood (experimental arm) to unmanipulated umbilical cord blood (standard of care arm) transplantation after a myeloablative CY/FLU/TBI conditioning. A 2:1 randomization will be employed with a higher chance of being assigned to the experimental arm. Phase/Status/Sponsor: Unknown phase; WITHDRAWN; Masonic Cancer Center, University of Minnesota.

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