Phase II Trial of Rituximab and Autologous Stem Cell Transplantation for Refractory B Cell Large Cell Lymphoma
- Determine the disease-free and overall survival of patients with refractory diffuse
large B-cell lymphoma treated with stem cell mobilization comprising rituximab,
cyclophosphamide, and filgrastim (G-CSF) followed by high-dose chemotherapy comprising
carmustine, etoposide, and cyclophosphamide and autologous peripheral blood stem cell
transplantation, rituximab, and sargramostim (GM-CSF).
- Determine any potential infectious complications in patients treated with this regimen.
- Determine the effect of GM-CSF on antibody-dependent cellular cytotoxicity in patients
treated with this regimen.
OUTLINE: Stem cell mobilization: Patients receive rituximab IV over 4-8 hours on days 1, 5,
8, and 13. Patients also receive cyclophosphamide IV over 1-2 hours on day 9 and filgrastim
(G-CSF) subcutaneously (SC) once daily beginning on day 10 and continuing until an adequate
number of peripheral blood stem cells (PBSC) are collected.
High-dose preparative regimen: 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.
Autologous PBSC transplantation: Patients undergo autologous PBSC transplantation on day 0.
Patients receive sargramostim (GM-CSF) SC once daily beginning on day 6 and continuing until
blood counts recover.
Post-transplant regimen: Patients receive GM-CSF SC once daily on days 42-73, 177-208,
362-393, 543-574, and 727-758. Patients also receive rituximab IV over 4-8 hours on days 45,
52, 59, 66, 180,187, 194, 201, 365, 372, 379, 386, 546, 553, 560, 567, 730, 737, 744, and
After completion of study treatment, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
2-year event free survival
Lode J. Swinnen, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|