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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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