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Reduced Intensity Conditioning Hematopoietic Cell Transplantation for Pediatric Patients With Hematologic Malignancies at High Risk for Transplant Related Mortality With Standard Transplantation
This is a phase II trial of reduced intensity conditioning with Bu/Flu/ATG in pediatric patients with hematologic malignancies at high risk for transplant related mortality with standard transplantation. Patients qualify based on organ system dysfunction, active but stable infection, history of previous transplant or late stage disease. We plan to enroll 45 patients through the Pediatric Blood and Marrow Transplant Consortium (PBMTC) and anticipate that the outcome of the trial will pave the way for phase II or III disease specific protocols addressing efficacy of the approach compared to standard transplant approaches in better risk patients.
Details
| Lead sponsor | University of Utah |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 47 |
| Start date | 2004-04 |
| Completion | 2009-07 |
Conditions
- Acute Leukaemia
- Chronic Disease
- Leukemia
- Myelodysplasia
- Lymphoma
Interventions
- Busulfan
- Anti-Thymocyte Globulin
- Fludarabine
- Cyclosporine
- Mycophenolate mofetil
Primary outcomes
- Number of High Risk Pediatric Patients With Successful Sustained Donor Engraftments — 24 months
Assessed donor engraftment in very high risk pediatric patients.
Countries
United States