Allogeneic Blood or Marrow Transplantation for Hematologic Malignancy and Aplastic Anemia
OBJECTIVES:
- Compare the morbidity, mortality, and overall outcome of patients with severe aplastic
anemia or hematologic malignancy treated with standard vs novel conditioning regimens
followed by allogeneic stem cell transplantation.
- Examine the influence of donor histocompatibility on outcome by comparing
matched/related, mismatched/related (with or without T-cell depletion), and
matched/unrelated transplants with stratification for type of preparative regimen.
- Ensure that patients with uncommon diagnoses will be treated in a uniform fashion with
the best therapy available.
OUTLINE: Patients are stratified according to risk of relapse (standard-risk: acute leukemia
in first complete remission, chronic myelogenous leukemia in first chronic phase, lymphoma
in sensitive first relapse or second remission, primary or untreated myelodysplastic
syndromes, or untreated severe aplastic anemia vs high-risk: all others).
Patients are assigned to one of the following conditioning regimens based on diagnosis, risk
of relapse, and donor relatedness:
- Regimen 1: Patients receive busulfan IV over 2 hours every 6 hours on days -7 to -4 and
cyclophosphamide IV over 2 hours on days -3 and -2.
- Regimen 2: Patients receive cyclophosphamide IV over 2 hours on days -5 to -2 and
anti-thymocyte globulin IV over 4-8 hours on days -5 to -3.
- Regimen 3: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4 and
total-body irradiation (TBI) twice daily on days -3 to -1.
- Regimen 4: Patients receive fludarabine IV over 30 minutes on days -6 to -2 and
melphalan IV over 1 hour on days -3 and -2.
- Regimen 5: Patients receive etoposide IV over 26 hours beginning on day -5,
cyclophosphamide IV over 2 hours on day -4, and TBI twice daily on days -3 to -1.
- Regimen 6: Patients receive cyclophosphamide IV over 24 hours, carboplatin IV over 24
hours, and thiotepa IV over 24 hours on days -7 to -4.
- Regimen 7: Patients receive fludarabine IV over 30 minutes on days -5 to -1 and
anti-thymocyte globulin IV over 4-8 hours on days -5 to -2.
- Regimen 8: Patients receive cyclophosphamide IV over 2 hours on days -5 and -4, TBI
twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4-8 hours on days -3
to -1.
- Regimen 9: Patients receive busulfan IV over 2 hours every 6 hours and anti-thymocyte
globulin IV over 4-8 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on
days -3 and -2.
All patients then receive donor stem cell infusions on day 0. Some patients may undergo
involved-field radiotherapy 4-8 weeks after transplant.
Patients are followed periodically post-transplant.
PROJECTED ACCRUAL: At least 405 patients will be accrued for this study within 5 years.
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Activity of allogeneic stem cell transplant
day 100
No
Philip L. McCarthy, MD
Study Chair
Roswell Park Cancer Institute
United States: Food and Drug Administration
CDR0000066968
NCT00003816
October 1998
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |