A Clinical Trial Evaluating I131-Tositumomab (Anti-CD20) With Escalating Doses of Fludarabine Followed by Autologous or Syngeneic Stem Cell Transplantation for Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma in Patients 60 Years of Age and Older
I. To estimate the maximally tolerated dose of fludarabine that can be combined with
131I-anti-CD20 (iodine I 131 tositumomab) delivering =< 27Gy to critical normal organs
followed by autologous or syngeneic transplantation in patients >= 60 years of age with
I. To assess the overall and progression-free survival of the above regimen in such
II. To evaluate the response rates of the above therapy.
III. To evaluate the toxicity and tolerability of the above therapy.
IV. To evaluate the feasibility of delivering concurrent high-dose radioimmunotherapy (RIT)
OUTLINE: This is a dose-escalation study of fludarabine phosphate as used in combination
with I 131 tositumomab and stem cell transplant.
Patients receive a dosimetric dose of iodine I 131 tositumomab intravenously (IV) over 40-60
minutes on day -24 followed by gamma camera imaging over the next 6 days. Patients then
receive a therapeutic dose of iodine I 131 tositumomab via central line over 40-60 minutes
on day -14. Patients also receive fludarabine phosphate IV once daily (QD) on days -11 to -9
OR days -11 or -7. Patients undergo autologous or syngeneic peripheral blood stem cell
transplantation on day 0.
Patients with circulating lymphoma cells by peripheral smear receive tositumomab IV over 1
hour OR rituximab IV over 1 hour followed by tositumomab IV over 1 hour before the
dosimetric iodine I 131 tositumomab infusion.
After completion of study treatment, patients are followed up at 1, 3, 6, and 12 months and
then annually thereafter.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose/dose limiting toxicity
Assessed according to Bearman scale for Regimen-Related Toxicities.
Up to 30 days post-transplant
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Food and Drug Administration
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|