A Phase II Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
OBJECTIVES:
Primary
- To assess the progression-free survival rate at 2 years after autologous stem cell
transplantation (ASCT) in patients with relapsed or primary refractory follicular
lymphoma treated with sargramostim (GM-CSF) and rituximab after ASCT.
Secondary
- To assess the safety of administering GM-CSF and rituximab after ASCT.
- To assess the effects of GM-CSF on the relative expression of activating and inhibitory
FcγR on circulating monocytes.
- To assess the effects of GM-CSF on the relative expression of activating and inhibitory
FcγR on circulating dendritic cells.
- To assess the effects of GM-CSF on the level of circulating FcγR.
- To assess the reconstitution of NK cells, NK-T cells, dendritic cell subsets, and
regulatory T-cells after ASCT.
OUTLINE:
- High-dose chemotherapy: Patients receive carmustine IV over 2 hours on day -7,
etoposide IV over 1 hour and cytarabine IV every 12 hours on days -6 to -3, and
melphalan IV on day -2.
- Autologous stem cell transplantation (ASCT): Patients undergo ASCT on day 0. Patients
receive filgrastim (G-CSF) subcutaneously (SC) once a day beginning on day 5 and
continuing until blood counts recover.
- Sargramostim (GM-CSF) and rituximab: Beginning approximately 7-10 weeks (49-70 days)
after ASCT, patients receive GM-CSF SC 3 times a week for 8 weeks and rituximab IV once
weekly for 4 weeks (beginning within 3 days after the first dose of GM-CSF). Patients
receive a second course of GM-CSF and rituximab (as above) beginning approximately
22-26 weeks (154-182 days) after ASCT.
After the completion of study treatment, patients are followed periodically for 2 years.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival rate at 2 years after autologous stem cell transplantation (ASCT)
2 years
No
Craig Moskowitz, MD
Principal Investigator
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
07-085
NCT00521014
October 2007
October 2013
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |