Randomized Trial Comparing Autologous Peripheral Blood Stem Cell Transplantation to Bone Marrow Transplantation for Patients Receiving High-Dose Chemotherapy and Transplantation for Recurrent Non-Hodgkin's Lymphoma
These patients would be enrolled in a high-dose protocol using carmustine, etoposide,
cytarabine, and cytoxan (BEAC) with autologous hematopoietic rescue. The patients will be
stratified according to good and poor prognosis category and relapsed vs. first partial
response categories. The patients will have bone marrow or peripheral stem cells collected
according to standard protocols. A standardized hematopoietic growth factor will be used
for mobilization and post-transplant. The patients' PSC or BM product will be assayed via
invitro-culture techniques for occult tumor, and by molecular biologic assays. The
patients' outcome for transplantation will be evaluated with response to transplantation,
relapse rates and event free survival being the measured end points.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to transplantation, relapse rates, and event free survival
follow up to death
No
Julie M Vose, MD
Principal Investigator
University of Nebraska
United States: Institutional Review Board
123-92
NCT00574626
December 1991
May 2010
Name | Location |
---|---|
University of Nebraska Medical Center | Omaha, Nebraska 68198-3330 |