Recurrent Grade 1 Follicular Lymphoma Clinical Trial
Official title:
Total Body Irradiation, Etoposide, Cyclophosphamide and Autologous Peripheral Blood Stem Cell Transplantation Followed by Randomization to Therapy With Interleukin-2 Versus Observation for Patients With Non-Hodgkin's Lymphoma
Randomized phase III trial to compare the effectiveness of interleukin-2 with that of observation following radiation therapy, combination chemotherapy, and peripheral stem cell transplantation in treating patients who have refractory or relapsed non-Hodgkin's lymphoma. Interleukin-2 may stimulate a person's white blood cells to kill non-Hodgkin's lymphoma cells. Giving interleukin-2 after radiation therapy, chemotherapy, and peripheral stem cell transplantation may kill more cancer cells
PRIMARY OBJECTIVES:
I. To compare the survival and disease-free survival of patients with non-Hodgkin's lymphoma
treated with post-transplant therapy with interleukin-2 (IL-2) or no further treatment.
Transplant therapy is total body irradiation (TBI), high-dose etoposide, cyclophosphamide
and peripheral blood stem cell transplant (PBSCT).
II. To assess the frequency and severity of toxicity associated with post-transplant IL-2
therapy.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease grade (low vs intermediate vs high), chemosensitive disease (yes vs no), partial or
complete response after initial induction chemotherapy (yes vs no), and performance status
(0-1 vs 2).
Part I: Autologous peripheral blood stem cells (PBSC) are harvested before study entry.
Patients undergo total body irradiation twice a day on days -8 to -5, high-dose etoposide IV
over 4 hours on day -4, and cyclophosphamide IV over 1 hour on day -2. PBSC are reinfused on
day 0 and then filgrastim (G-CSF) may be administered subcutaneously or IV on days 0-21.
Part II: Within 28-80 days after PBSC transplantation and after recovery from any toxic
effects, patients with no active recurrent or progressive disease are randomized to 1 of 2
treatment arms.
Arm I: Patients receive interleukin-2 IV continuously on days 1-4 and 9-18.
Arm II: Patients undergo observation only.
Patients are followed every 3 months for 1 year, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: Approximately 275 patients will be accrued for this study within 3.5-5.9
years.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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