A Study of 131I-Tositumomab (Bexxar®) Consolidation in Patients With B-Cell Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma in First Remission
PRIMARY OBJECTIVES:
I. To estimate the progression-free survival (PFS) at 2 years following administration of
131I-tositumomab (tositumomab and iodine I 131 tositumomab) in patients with CLL/SLL who
achieve a complete response (CR) or partial response (PR) with prior therapy.
II. To improve the response rate by administering 131I-tositumomab to patients who have
achieved a PR not a CR after any prior therapy.
III. To eliminate residual disease (documented by flow cytometry or polymerase chain
reaction [PCR]) using 131I-tositumomab in patients who have achieved a CR after any prior
therapy.
SECONDARY OBJECTIVES:
I. To evaluate the toxicities of 131I-tositumomab in 1st remission patients with previously
treated CLL/SLL.
OUTLINE:
Patients receive tositumomab and iodine I 131 tositumomab intravenously (IV) over 90 minutes
on day 0 and then again 7-14 days later over 30-60 minutes.
After completion of study treatment, patients are followed up weekly for 3 months, every 3
months for 2 years, every 6 months for 3 years, and then annually thereafter.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Probability of PFS
2 years
No
John Pagel
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
PSOC 2301
NCT00476047
February 2007
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |