Cord Blood Transplantation in Children and Young Adults With Hematologic Malignancies and Non-malignant Disorders
Memorial Sloan Kettering Cancer Center
Summary
This is a single-arm study to investigate 1-year treatment related mortality (TRM) in patients with life threatening non-malignant and malignant hematologic disorders who do not have a matched related donor for allogeneic transplantation.
Eligibility
- Age range
- Up to 21 years
- Sex
- All
- Healthy volunteers
- No
Participant Inclusion Criteria: Age and Donor Status: Patients with age ≤ 21 years at time of consent with no available and suitably matched related or unrelated donor in the required time period. Diagnoses : I. Acute myelogenous leukemia (AML) : * Complete first remission (CR1) at high risk for relapse such as any of the following: * Known prior diagnosis of myelodysplasia (MDS) or myeloproliferative disorder (MPS). * Therapy-related AML (t-AML). * White cell count at presentation \> 100,000. * Presence of extramedullary leukemia at diagnosis. * Any unfavorable subtype by FAB…
Interventions
- DrugClofarabine
Clofarabine
- DrugFludarabine
Fludarabine
- DrugBusulfan
Busulfan per PK
- DrugCyclosporine-A
GVHD prophylaxis will consist of cyclosporine-A (CSA) and mycophenolate mofetil (MMF) starting day -3.
- DrugMycophenolate Mofetil
GVHD prophylaxis will consist of cyclosporine-A (CSA) and mycophenolate mofetil (MMF) starting day -3.
- BiologicalCord Blood Graft
The CB graft will be infused on day 0 per standard practice
Location
- Memorial Sloan Kettering Cancer CenterNew York, New York