Randomized Phase III Trial Of Rituximab (NSC #687451) And Autologous Stem Cell Transplantation For B Cell Diffuse Large Cell Lymphoma
- Compare disease-free survival of patients with relapsed or progressive B-cell diffuse
large cell lymphoma undergoing stem cell transplantation with or without
- Evaluate the effect of rituximab, administered post-transplant, on the
procedure-related mortality of these patients.
- Determine the potential infectious complications of the addition of this drug to
autologous stem cell transplantation in these patients.
- Compare overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
relapse (relapsed more than 6 months after either initial complete remission [CR] or CR with
positive positron emission tomography or MRI [gallium] vs failed to achieve initial CR or
relapsed within 6 months after either initial CR or CR with positive PET or MRI [gallium])
and prior rituximab (yes vs no).
Stem cell mobilization
- Patients receive rituximab IV over 4-8 hours on days 1 and 5. Patients also receive
cyclophosphamide IV over 2 hours on day 8 and filgrastim (G-CSF) subcutaneously (SC)
beginning on day 9 and continuing until the last day of apheresis. Stem cells are
collected over 1-3 days.
- Regimen A (patients who have received prior radiotherapy or are ≥ 61 years of age):
Patients receive carmustine IV over 2 hours on day -6, etoposide IV over 4 hours on day
-4, and cyclophosphamide IV over 2 hours on day -2.
- Regimen B (all other patients): Patients undergo total body irradiation twice daily on
days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and
cyclophosphamide IV over 2 hours on day -2.
Stem cells are reinfused on day 0. Patients are then randomized to one of two
post-transplant treatment arms.
- Arm I (rituximab): Patients receive G-CSF SC beginning on day 6 and continuing until
blood counts recover. Patients receive rituximab IV over 4-8 hours every 7 days for 4
doses, starting on day 45 post-transplant. Course of rituximab is repeated beginning on
day 180 post-transplant.
- Arm II (no rituximab): Patients receive G-CSF as in arm I. Patients are followed for 10
PROJECTED ACCRUAL: A total of 427 patients will be accrued for this study within 3.5 years.
Allocation: Randomized, Primary Purpose: Treatment
Ian W. Flinn, MD, PhD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government