Status:
ACTIVE_NOT_RECRUITING
Giving Chemotherapy for a Shortened Amount of Time Before a Stem Cell Transplantation
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to see if a condensed version of the chemotherapy regimen busulfan, melphalan, fludarabine (bu/mel/flu) and the drug antithymocyte globulin (ATG-also referred to as rATG o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04098393
Start Date
September 18 2019
End Date
September 1 2026
Last Update
June 29 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065