A Phase II Trial Evaluating: Radioiodinated Anti-B1 (Anti-CD20) Antibody With Autologous Stem Cell Transplantation For Relapsed Or Refractory Non-Hodgkin's Lymphoma In Patients 60 Years Of Age And Older
- Determine the progression-free survival of older patients with relapsed or refractory
non-Hodgkin's lymphoma treated with iodine I 131 tositumomab followed by autologous
stem cell transplantation.
- Determine the overall survival of patients treated with this regimen.
- Determine the toxicity and tolerability of this regimen in these patients.
- Radioimmunotherapy: Patients receive a test dose of iodine I 131 tositumomab on day -24
to determine biodistribution. Patients then receive therapeutic iodine I 131
tositumomab IV over 1 hour on day -14 and are entered into radiation isolation until
- Autologous stem cell transplantation: Patients undergo autologous bone marrow or
peripheral blood stem cell transplantation on day 0. Patients undergoing bone marrow
transplantation receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously
beginning on day 0 and continuing until blood counts recover.
Patients are followed at 1, 3, 6, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease-free survival measured continuously
from date of transplant through date of death
Ajay K. Gopal, MD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|