Cord Blood Transplantation in Children and Young Adults With Blood Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT07566377
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 26 Years
Healthy Volunteers
Not accepted

Interventions

  • Cord Blood Units — BIOLOGICAL
    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
  • Total Body Irradiation — RADIATION
    Hyper-fractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Treatment planning begins with simulation.
  • Cyclophosphamide — DRUG
    Cyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis.
  • Fludarabine — DRUG
    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 — DRUG
    Clofarabine, a purine (deoxyadenosine) nucleoside analog, is metabolized to clofarabine 5'-triphosphate.
  • Busulfan — DRUG
    Busulfan is a bifunctional alkylating agent known chemically as 1,4- butanediol, dimethanesulfonate.
  • Thiotepa — DRUG
    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 — DRUG
    Tacrolimus inhibits T-lymphocyte activation
  • Mycophenolate Mofetil — DRUG
    Mycophenolate exhibits a cytostatic effect on T and B lymphocytes.
  • Cyclosporine — DRUG
    Cyclosporine is a calcineurin inhibitor that inhibits production and release of interleukin II and inhibits interleukin II-induced activation of resting T-lymphocytes.

Study Details

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 Dates

Start date
Apr 28, 2026
Status verified
May 2026
Primary completion
Apr 28, 2030
Completion
Apr 28, 2030

Study Design

Enrollment
71 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Patients with High-Risk Disease
    Participants 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).
  • Experimental: Cohort 2: Patients with Very High-Risk Disease
    1. 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.

Primary Outcome Measure

Disease-free Survival (DFS) [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Andromachi Scaradavou, MD
1-833-MSK-KIDS

Find similar trials in New York, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Memorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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