Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase I, Dose-Escalation, Open-Label, Multicenter Study of Iodine-131, Anti-B1 Antibody for Intermediate- and High-Risk B-Cell Chronic Lymphocytic Leukemia
The purpose of this study is to test the safety of Iodine-131 Anti-B1 Antibody, to see what effects it has on patients with CLL and to determine the highest dose of Iodine-131 Anti-B1 Antibody that can be given without causing severe side effects.
The primary endpoint is to determine the maximum tolerated dose of Iodine-131 Anti-B1
Antibody in patients with CLL. Secondary endpoints include assessment of response rate,
duration of response, relapse free survival, time to treatment failure, safety, and
survival.
The dose escalation will be started at 35cGy for patients with platelet counts > 100,000
cells/mm3 (Cohort A) and increased by groups in 10cGy increments until the maximum tolerated
dose (MTD) is reached. Subsequently, patients with platelet counts from 75,000-100,000
cells/mm3 (Cohort B) will be enrolled starting at 10cGy below the MTD reached in Cohort A
and the dose will be escalated in 10cGy increments up to the MTD.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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