Cord Blood Transplantation for Children and Young Adults with Blood Cancer
This study is looking at whether cord blood transplantation (CBT) is an effective treatment for children and young adults up to age 26 who have blood cancers like acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes, or lymphoma. You might be eligible if you have high-risk disease and no suitable related or unrelated donor available within four weeks. The study uses cord blood units, along with radiation (Total Body Irradiation) and chemotherapy drugs like Cyclophosphamide, Fludarabine, and Clofarabine. Researchers will measure how long patients live without their disease returning (Disease-free Survival) at one year to see how well the treatment works. The study aims to enroll 71 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It aims to enroll 71 participants, but the phase is not specified.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Disease-free survival will be measured at 1 year after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07566377
Cord Blood Transplantation in Children and Young Adults With Blood Cancer
Recruiting
PHASE2Up to 26InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~71 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:Cord Blood UnitsTotal Body IrradiationCyclophosphamideFludarabineClofarabineBusulfan
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-free Survival (DFS)
Measured over 1 year
Conditions
Where it's being run
1 sites across 1 statesNew York1
Study leadership
- Andromachi Scaradavou, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
Leukemias of ambiguous lineage or of other types with \< 5% blasts by bone marrow morphology.
Patients with persistent/relapsed disease with cytogenetic, flow cytometric or molecular aberrations in \< 5% of cells.
Chronic myelogenous leukemia: Patients with history of blast crisis or accelerated phase.
Any leukemia that developed after gene therapy or cell therapy
Any IPSS risk category with life-threatening cytopenia(s).
Any IPSS risk category with high risk cytogenetic/molecular findings (5, 7, 8, complex karyotype, or TP53)
Patients with aggressive histology (such as, but not limited to, diffuse large B-cell NHL, mantle cell NHL, and T-cell NHL) in CR.
Patients with indolent B cell NHL (such as, but not limited to, follicular, small cell or marginal zone NHL) will have 2nd or subsequent progression with stable disease/ CR/ PR with no single lesion equal to or more than 5 cm.
Patients with HL without progression of disease (POD) after salvage chemotherapy with no single lesion ≥5 cm.
Acute myelogenous leukemia (AML) or Myelodysplastic Syndrome (MDS): Relapse after previous transplant, in CR after induction therapy. MRD positive status by multi-parameter flow cytometry is accepted.
Acute lymphoblastic leukemia (ALL): Relapse after previous transplant, in CR after induction therapy and/or antibody therapy/CAR T cells. MRD positive status after targeted therapy, as evaluated by multi-parameter flow cytometry is accepted.
Other: patients with leukemia or lymphoma, who, in the opinion of their physician, are not likely to have reduction in disease burden with further chemotherapy. 2. Patients with relapsed/refractory disease at either first or second allogeneic transplant, with up to 30% bone marrow blasts by multiparameter flow cytometry or morphology. ° Relapse after previous transplant with \< 30% blasts by bone marrow morphology, or with cytogenetic, flow cytometric, or molecular abnormalities in \< 30% of bone marrow cells, after induction therapy.
Bilirubin ≤ 1.5 mg/dL (unless benign congenital hyperbilirubinemia).
ALT ≤ 3 x upper limit of normal.
Pulmonary function (FVC, FEV1 and DLCO corrected for hemoglobin) ≥ 50% predicted.
In young children unable to perform pulmonary function testing: pulse oximetry \>92% in room air, and a normal CT of the chest (if CT is not normal, the child needs to be evaluated and cleared by pediatric pulmonary physician).
Left ventricular ejection fraction \> 50%.
Age-adjusted Hematopoietic Cell Transplantation-Comorbidity Index (aaHCT-CI) ≤ 7.
Female patients of childbearing potential must have a negative serum pregnancy test within 7 days of enrolment and must be willing to use an effective contraceptive method while enrolled in the study.
Renal: Serum creatinine (SCr) ≤ 1.5 x normal for age. If SCr is outside the normal range, then CrCl \> 50 mL/min (calculated or estimated) or estimated GFR (mL/min/1.73m2) \>30% of predicted normal for age.
Exclusion
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.
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.
What this trial measures
- Disease-free Survival (DFS)1 year
Disease-free Survival (DFS) at 1 year after CBT