Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for Chronic Lymphocytic Leukemia
|ClinicalTrials.gov Identifier: NCT00022880|
Recruitment Status : Unknown
Verified August 2004 by Corixa Corporation.
Recruitment status was: Active, not recruiting
First Posted : August 17, 2001
Last Update Posted : June 24, 2005
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia||Drug: Iodine-131 Anti-B1 Antibody||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022880
|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|