A Prospective, Comparative Trial of Allogeneic Versus Autologous Stem Cell Transplantation for High Risk Lymphoma
OBJECTIVES: I. Compare the relapse rate, progression free survival, and overall survival in
patients with high risk non-Hodgkin's lymphoma or Hodgkin's disease treated with allogeneic
vs autologous stem cell transplantation. II. Compare the toxicities (short and long term) of
these 2 regimens in these patients.
OUTLINE: Cytoreductive therapy: Patients receive 3 courses of salvage chemotherapy (e.g.,
dexamethasone, high dose cytarabine, and cisplatin (DHAP); etoposide, methylprednisolone,
high dose cytarabine, and cisplatin (ESHAP); fludarabine, mitoxantrone, and dexamethasone
(FND)). Harvest: Patients with an HLA identical sibling donor are assigned to the allogeneic
peripheral blood stem cell (PBSC) transplantation group. Patients without an HLA identical
sibling are assigned to the autologous PBSC transplantation group. Allogeneic OR autologous
PBSC are harvested. Conditioning regimen: Patients receive high dose chemotherapy comprised
of cyclophosphamide IV over 1 hour on days -6 to -3 and carmustine IV over 3 hours and
etoposide IV over 3 hours on days -6 to -4. PBSC are infused on day 0. Patients are followed
weekly for 3 months, then monthly for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study over 4 years.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
determine relapse rate after allogeneic versus autologous hematopoietic progenitor cell transplantation
Steven C. Goldstein, MD
H. Lee Moffitt Cancer Center and Research Institute
United States: Federal Government
|H. Lee Moffitt Cancer Center and Research Institute||Tampa, Florida 33612|
|Florida Cancer Specialists||Fort Myers, Florida 33901|