Status:
ACTIVE_NOT_RECRUITING
A Modified Dose of Rabbit Anti-thymocyte Globulin (rATG) in Children and Adults Receiving Treatment to Help Prepare Their Bodies for a Bone Marrow Transplant
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Acute Myeloid Leukemia (AML)
Acute Lymphoid Leukemia (ALL)
Eligibility:
All Genders
4+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if conditioning regimens that include personalized rabbit ATG (P-rATG) help the immune system recover sooner and decrease the chances of transplant-related side eff...
Eligibility Criteria
Inclusion
- Patients receiving first peripheral blood mobilized ex-vivo CD34-selected T cell depleted allo-HCT for the following hematologic malignant conditions:
- Acute myeloid leukemia (AML) with intermediate or high-risk features in CR1 or Relapse AML in ≥ CR2.
- Must have MRD \<5% (flow cytometry, molecular and/or cytogenetics accepted).
- Acute leukemias of ambiguous lineage in ≥ CR1.
- Must have MRD \<5% (flow cytometry, molecular and/or cytogenetics accepted).
- Acute lymphoid leukemia (ALL) in CR1 with clinical, flow cytometric, or molecular features indicating a high risk for relapse, or ALL in ≥ CR2.
- Adult Patients - recommended but not required to be MRDnegative (by flow cytometry, molecular and/or cytogenetics).
- Pediatric Patients - Must be MRD-negative by flow cytometry, molecular and/or cytogenetics.
- Myelodysplastic syndromes (MDS) 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 cytopenia.
- 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.
- Able to tolerate cytoreduction
- Patients age:
- Regimen A: 4 - 60 years
- Regimen B - no age restriction
- Adequate organ function is required, defined as follows:
- Hepatic: 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.
- Hepatic: AST, ALT, and alkaline phosphatase \< 2.5 times the upper limit of normal unless thought to be disease-related.
- Renal: serum creatinine \<1.5x normal for age. If serum creatinine is outside the normal range, then CrCl \> 50 mL/min/1.73m2 (calculated or estimated) or GFR (mL/min/1.72m2) \>30% of predicted normal for age.
- Normal GFR by Age
- 1 week 40.6 + / - 14.8
- 2 - 8 weeks 65.8 + / - 24.8
- °\> 8 weeks 95.7 +/- 21.7
- 2 - 12 years 133 +/- 27
- 13 - 21 years (males) 140 +/- 30
- 13 - 21 years (females) 126.0 + / - 22.0
- Cardiac: LVEF ≥ 50% by MUGA or resting echocardiogram.
- Pulmonary: Pulmonary function testing (FEV1 and corrected DLCO) ≥ 50% predicted (pediatric patients unable to complete PFTs will need oxygen saturation as recorded by pulse oximetry of ≥92% on room air).
- Adequate performance status:
- Age ≥ 16 years: ECOG ≤ 1 or Karnofsky 70%
- Age \< 16 years: Lansky 70%
- Each patient must be willing to participate as a research subject and must sign an informed consent form or legal guardian with assent as appropriate.
Exclusion
- Patients with active extramedullary disease.
- Patients with active central nervous system malignancy.
- Uncontrolled infection at the time of allo-HCT.
- Patients who have undergone previous allo-HCT.
- 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 parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests.
- Donor Inclusion Criteria:
- Related or Unrelated Donors:
- °8/8 HLA matched at A, B, C, and DRB1 loci, as tested by DNA analysis.
- Able to provide informed consent for the donation process per institutional standards.
- Meet standard criteria for donor collection (e.g. National Marrow Donor Program Guidelines or collecting center guidelines as approved by treating physician).
- Provide GSCF mobilized peripheral blood stem cells
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2026
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT04872595
Start Date
April 30 2021
End Date
April 1 2026
Last Update
September 4 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065