Shorter chemo before transplant may cut severe side effects for blood cancer patients
NCT ID NCT04098393
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This study tests a condensed version of a chemotherapy regimen (busulfan, melphalan, fludarabine) plus an immune-suppressing drug (ATG) given before a donor stem cell transplant. The goal is to see if this shorter approach causes fewer severe side effects within 30 days after transplant. Adults with certain blood cancers, such as acute leukemia or high-risk myelodysplastic syndrome, may be eligible.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- busulfan, melphalan, fludarabine, and antithymocyte globulin
- What this could lead to
- If successful, this condensed regimen could make stem cell transplants safer for people with blood cancers by reducing severe side effects.
- What could go wrong
- This is a small, early-phase pilot study, so results may not apply broadly. The chemotherapy itself carries risks of serious toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 39 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2019
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients aged ≥ 18 years old. * Patients with any of the following hematologic malignancies for which allo-HCT is indicated, including: * Acute myeloid leukemia (AML) with intermediate or high-risk features in CR1. * Relapsed AML in ≥ CR2. * Acute leukemias of ambiguous lineage in ≥ CR1. * Acute lymphoid leukemia (ALL) in CR1 with clinical, flow cytometric, or molecular features indicating a high risk for relapse, or ALL in ≥ CR2. * CML meeting one of the following criteria: * Failed response to or intolerant to BCR-ABL tyrosine kinase inhibitors (TKIs). * CML with BCR-ABL mutation consistent with poor response to TKIs (e.g., T315I mutation) * CML in accelerated phase or blast crisis with \<10% blasts after therapy, or in second chronic phase. * Myelodysplastic syndromes (MDS), myeloproliferative neoplasms (MPN), or MDS/MPN overlap syndromes with least one of the following: * Revised International Prognostic Scoring System risk score of intermediate or higher at the time of transplant evaluation. * Life-threatening cytopenias. * Karyotype or genomic changes that indicate high risk for progression to acute myelogenous leukemia, including abnormalities of chromosome 7 or 3, mutations of TP53, or complex or monosomal karyotype. * Therapy related disease or disease evolving from other malignant processes. * Chronic myelomonocytic leukemia (CMML-1 or CMML-2). * Severe aplastic anemia. * Relapsed Hodgkin lymphoma meeting both of the following criteria: * Responding to therapy prior to enrollment. * Relapse after autologous HCT or are ineligible for autologous HCT. * Relapsed non-Hodgkin lymphoma meeting both of the following criteria: * Responding to therapy prior to enrollment. * Relapse after prior autologous HCT or are ineligible for autologous HCT. * High-risk multiple myeloma following autologous HCT or relapsed multiple myeloma following autologous HCT with chemosensitive disease. * Adequate organ function is required, defined as follows: * Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia. Patients with hyperbilirubinemia related to paroxysmal nocturnal hemoglobinuria or other hemolytic disorders are eligible with PI approval. * AST, ALT, and alkaline phosphatase \< 3 times the upper limit of normal unless thought to be disease-related. * Creatinine clearance ≥ 50 ml/min (calculated by Cockcroft Gault) * LVEF ≥ 45% by MUGA or resting echocardiogram. * Pulmonary function (FEV1 and corrected DLCO) ≥ 50% predicted. * Adequate performance status of ECOG ≤ 2. * Each patient must be willing to participate as a research subject and must sign an informed consent form. Exclusion Criteria: * Patients with active extramedullary disease. * Patients with active central nervous system malignancy. * Active and/or uncontrolled infection at the time of allo-HCT. * Patients who have undergone previous allo-HCT. * Patients who have undergone previous autologous HCT within the last 6 months, with the exclusion of high-risk multiple myeloma patients. * Patient seropositivity for HIV I/II and/or HTLV I/II. * Females who are pregnant or breastfeeding. * Patients unwilling to use contraception during the study period. * Patient or guardian unable to give informed consent or unable to comply with the treatment protocol. Donor Inclusion and Exclusion Criteria: * Must be a 10/10 HLA genotypically matched related or unrelated donor at A, B, C, DRB1, and DQB1 loci, as tested by DNA analysis. * Able to provide informed consent for the donation process per institutional standards. * Meet standard criteria for donor collection as defined by the National Marrow Donor Program Guidelines.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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