Spots Global Cancer Trial Database for Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia
Official Title: Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia
Study ID: NCT00021749
Interventions
Study Description
Brief Summary: This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.
Detailed Description: This study is a two-part phase I-II study. Part 1 will determine the MTD of Genasense in patients with CLL. This dose will then be tested in a non-randomized, multi-center, Phase II sequential clinical trial of Genasense used alone for treatment of patients with advanced CLL. Pharmacokinetics of Genasense and kinetics of Bcl-2 down regulation and re-expression in CLL cells will be followed in selected patients.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Long Island Jewish Medical Center, New Hyde Park, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States
San Antonio Cancer Institute, San Antonio, Texas, United States
Contact Details
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