Finding studies
Finding studies
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Lead
Memorial Sloan Kettering Cancer Center
With
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.
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
