About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Chloroma >2 cm.
Active and uncontrolled infection (bacterial/fungal/viral) at time of transplant.
HIV infection.
Seropositivity for HTLV-1.
Trial design
Parallel
Treatments tested in this trial
Cord Blood Units
Biological/VaccineCord 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
RadiationHyper-fractionated TBI is administered by a linear accelerator at a dose rate of \<20 cGy/minute. Treatment planning begins with simulation.
Cyclophosphamide
DrugCyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis.
Fludarabine
DrugFludarabine 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
DrugClofarabine, a purine (deoxyadenosine) nucleoside analog, is metabolized to clofarabine 5'-triphosphate.
Busulfan
DrugBusulfan is a bifunctional alkylating agent known chemically as 1,4- butanediol, dimethanesulfonate.
Thiotepa
DrugThiotepa 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
DrugTacrolimus inhibits T-lymphocyte activation
Mycophenolate Mofetil
DrugMycophenolate exhibits a cytostatic effect on T and B lymphocytes.
Cyclosporine
DrugCyclosporine is a calcineurin inhibitor that inhibits production and release of interleukin II and inhibits interleukin II-induced activation of resting T-lymphocytes.
Treatment groups
Trial outcomes
Primary outcomes
Disease-free Survival (DFS)
Disease-free Survival (DFS) at 1 year after CBT
Sponsors and contacts
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