Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for Chronic Lymphocytic Leukemia
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
|Study Start Date:||July 1999|
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.
|United States, California|
|Stanford University Medical Center|
|Palo Alto, California, United States, 94305|
|United States, New York|
|Long Island Jewish Medical Center|
|New Hyde Park, New York, United States, 11041|