A Prospective Randomized Trial of VP-16 Plus G-CSF Plus Rituximab vs VP-16 Plus G-CSF Alone for Peripheral Blood Progenitor Cell Mobilization Prior to Autologous Stem Cell Transplantation for B Cell Lymphoid Malignancies
- Determine whether mobilization with etoposide and filgrastim (G-CSF) with or without
rituximab influences CD34+ cell yield in patients undergoing autologous peripheral
blood stem cell transplantation for B-cell non-Hodgkin's lymphoma.
- Determine the acute toxicity of rituximab in combination with etoposide and G-CSF for
peripheral blood stem cell mobilization in these patients.
OUTLINE: This is a randomized study.
- Stem cell mobilization: Patients are randomized to 1 of 2 mobilization arms.
- Arm I: Patients receive rituximab IV over 4 hours on days 1, 8, and 15. Patients
also receive etoposide IV over 4 hours on day 15 and filgrastim (G-CSF)
subcutaneously (SC) beginning on day 17 and continuing until approximately day 25.
Patients then undergo apheresis over 5 days or until an adequate amount of stem
cells are collected. After stem cell collection is completed, patients proceed to
the preparative regimen.
- Arm II: Patients receive etoposide IV over 4 hours on day 1 and G-CSF SC beginning
on day 3 and continuing until approximately day 11. Patients then undergo
apheresis over 5 days or until an adequate amount of stem cells are collected.
After stem cell collection is completed, patients proceed to the preparative
- Preparative regimen: Patients receive oral busulfan once daily on days -8 to -4,
etoposide IV over 4 hours on day -4, and cyclophosphamide IV over 2 hours on days -3
- Autologous peripheral blood stem cell transplantation (PBSCT): Patients undergo
autologous PBSCT on day 0. Beginning on day 5, patients receive G-CSF SC or IV once
daily until blood counts recover.
After completion study treatment, patients are followed periodically for 10 years.
PROJECTED ACCRUAL: A total of 54 patients will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Correlate CD34+ cell yields with the addition of rituximab
At least two weeks prior to transplant
Brian J. Bolwell, MD
Cleveland Clinic Taussig Cancer Institute
United States: Institutional Review Board
|Cleveland Clinic Taussig Cancer Institute||Cleveland, Ohio 44195|