Cord Blood Transplantation in Children and Young Adults With Blood Cancer

Recruiting now · Phase 2

Conditions studied: Acute Myelogenous Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndromes, Non-hodgkin Lymphoma, Hodgkin Lymphoma, Leukemia, Lymphoma, Graft-versus-host Disease

In brief

The purpose of this study is to find out whether Cord Blood Transplantation/CBT as the first or second transplant is an effective treatment for children and young adults with blood cancer.

Key facts

Study ID

NCT07566377

Run by

Memorial Sloan Kettering Cancer Center

People needed

71

Starts

2026-04-28

Expected to finish

2030-04-28

Last updated by the study team

2026-05-14

Who can join

Age: any, up to 26. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A patient cannot be considered eligible for this study unless ALL of the following conditions are met.
• ° Disease type
• Cohort 1, High Risk Disease: Patients with age ≤ 26 years at the time of informed consent with no available and suitably matched related or unrelated donor within 4 weeks, with one of the following diagnoses:
• I. Acute myelogenous leukemia (AML):
• Complete first remission (CR1) with blast count < 5% by bone marrow morphology at high risk for relapse such as any of the following:
• Known prior diagnosis of myelodysplasia (MDS)
• High risk cytogenetics (e.g., those associated with MDS, abnormalities of 5, 7, 8, complex karyotype) and/or high-risk molecular abnormalities (e.g., TP53)
• Requirement for 2 or more inductions to achieve CR1
• Therapy-related AML (t-AML) or therapy-related myeloid neoplasm (t-MN) (including after therapy for other malignancy, and/or gene therapy or cell therapy)
• Presence of Minimal/Measurable Residual Disease (MRD+) by cytogenetics, flow cytometry or molecular methods (at End of Induction or End of Consolidation)
• Other high-risk features not defined above.
• Complete second remission (CR2) or subsequent remission, with blast count < 5% by bone marrow morphology
• Presence of MRD by multiparameter flow cytometry at pre-transplant evaluation is acceptable.
• II. Acute lymphoblastic leukemia (ALL):
• Complete first remission (CR1) with MRD negative status by multicolor flow cytometry, at high risk for relapse such as any of the following:
• Presence of any high risk cytogenetic abnormalities such as t(9;22), t(1;19), t(4;11) or other, KMT2A (11q23) or other high risk molecular abnormality
• Failure to achieve complete remission (CR) after four weeks of induction therapy (transplant to follow antibody therapy and/or CAR T cells)
• Persistence or recurrence of MRD on therapy (Transplant to follow antibody therapy and/or CAR T cells)
• T-ALL in CR even with presence of MRD
• Other high-risk features not defined above
• Complete second remission (CR2) or subsequent remission with MRD negative status by multiparameter flow cytometry.
• Relapse in less than 36 months from CR1
• Relapse for T-ALL
• Patients after antibody therapy (e.g., blinatumomab, inotuzumab, other) and/or CAR-T cell therapy that resulted in MRD negative status by multiparameter flow cytometry.
• III. Other acute leukemias:

You may not qualify if…

• Exclusion criteria for both cohorts:
• ° Inadequate performance status/ organ function.
• ° Active CNS leukemic involvement.
• Chloroma >2 cm.
• Active and uncontrolled infection (bacterial/fungal/viral) at time of transplant.
• HIV infection.
• Seropositivity for HTLV-1.
• Pregnancy or breast feeding.
• Patient or guardian unable to give informed consent or unable to comply with the treatment protocol including appropriate supportive care, long-term follow-up, and research tests.
• Any abnormal condition or lab result that is considered by the PI capable or altering patient's condition or study outcome.
• Cohort 2 Very High-Risk Disease (additional to above):
• ° Allogeneic HCT in the preceding 4 months.
• Note (1): Prior checkpoint inhibitors/blockade in the last 12 months: eligibility to be discussed with study PI.
• Note (2): For patients with known HBV and/or HCV infection :
• For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

Where it is running

• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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