Cord Blood Transplantation in Children and Young Adults With Blood Cancer
1 other identifier
interventional
71
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2026
Typical duration for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 28, 2026
CompletedFirst Submitted
Initial submission to the registry
April 29, 2026
CompletedFirst Posted
Study publicly available on registry
May 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 28, 2030
May 5, 2026
April 1, 2026
4 years
April 29, 2026
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease-free Survival (DFS)
Disease-free Survival (DFS) at 1 year after CBT
1 year
Study Arms (6)
Cohort 1: Patients with High-Risk Disease + Regimen A
EXPERIMENTALParticipants in complete remission (CR; bone marrow blasts \<5% by morphology) with no prior allogeneic transplant, who require allogeneic transplantation and do not have human leukocyte antigen (HLA)-matched related or unrelated donors readily available within 4 weeks. For participants with AML/MDS, MRD (Measurable/Minimal Residual Disease) positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry); participants with ALL need to be in MRD negative status (evaluated by multiparameter flow cytometry).
Cohort 1: Patients with High-Risk Disease + Regimen B
EXPERIMENTALParticipants in complete remission (CR; bone marrow blasts \<5% by morphology) with no prior allogeneic transplant, who require allogeneic transplantation and do not have human leukocyte antigen (HLA)-matched related or unrelated donors readily available within 4 weeks. For participants with AML/MDS, MRD (Measurable/Minimal Residual Disease) positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry); participants with ALL need to be in MRD negative status (evaluated by multiparameter flow cytometry).
Cohort 1: Patients with High-Risk Disease + Regimen C
EXPERIMENTALParticipants in complete remission (CR; bone marrow blasts \<5% by morphology) with no prior allogeneic transplant, who require allogeneic transplantation and do not have human leukocyte antigen (HLA)-matched related or unrelated donors readily available within 4 weeks. For participants with AML/MDS, MRD (Measurable/Minimal Residual Disease) positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry); participants with ALL need to be in MRD negative status (evaluated by multiparameter flow cytometry).
Cohort 2: Patients with Very High-Risk Disease + Regimen A
EXPERIMENTAL1. Participants in CR (bone marrow blasts \<5% by morphology) who had prior allogeneic transplant and disease recurrence. 1. Participants with AML/MDS: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry) 2. Participants with ALL: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry). 3. The second transplant will take place at least 4 months after the first. 2. Participants with relapsed/refractory disease at first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology.
Cohort 2: Patients with Very High-Risk Disease + Regimen B
EXPERIMENTAL1. Participants in CR (bone marrow blasts \<5% by morphology) who had prior allogeneic transplant and disease recurrence. 1. Participants with AML/MDS: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry) 2. Participants with ALL: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry). 3. The second transplant will take place at least 4 months after the first. 2. Participants with relapsed/refractory disease at first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology.
Cohort 2: Patients with Very High-Risk Disease + Regimen C
EXPERIMENTAL1. Participants in CR (bone marrow blasts \<5% by morphology) who had prior allogeneic transplant and disease recurrence. 1. Participants with AML/MDS: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry) 2. Participants with ALL: MRD positive status at the time of transplant is accepted (evaluated by multiparameter flow cytometry). 3. The second transplant will take place at least 4 months after the first. 2. Participants with relapsed/refractory disease at first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology.
Interventions
Cord Blood \[(HPC(CB)\] products are minimally manipulated unrelated allogeneic cord blood units that have been collected, processed and stored in public Cord Blood banks
Hyper-fractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Treatment planning begins with simulation.
Cyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis.
Fludarabine phosphate is rapidly dephosphorylated to 2- fluoro-ara- A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2- fluoro-ara-ATP
Clofarabine, a purine (deoxyadenosine) nucleoside analog, is metabolized to clofarabine 5'-triphosphate.
Busulfan is a bifunctional alkylating agent known chemically as 1,4- butanediol, dimethanesulfonate.
Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
Tacrolimus inhibits T-lymphocyte activation
Mycophenolate exhibits a cytostatic effect on T and B lymphocytes.
Cyclosporine is a calcineurin inhibitor that inhibits production and release of interleukin II and inhibits interleukin II-induced activation of resting T-lymphocytes.
Eligibility Criteria
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:
- +42 more criteria
You may not qualify if:
- ° 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Rockville Centre, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andromachi Scaradavou, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2026
First Posted
May 5, 2026
Study Start
April 28, 2026
Primary Completion (Estimated)
April 28, 2030
Study Completion (Estimated)
April 28, 2030
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.