Phase I/II Study of Genasense in Patients With Chronic Lymphocytic Leukemia
This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.
Chronic Lymphocytic Leukemia
Drug: Oblimerson sodium, G3139
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia|
|Study Start Date:||January 2001|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
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.
|United States, New York|
|Long Island Jewish Medical Center|
|New Hyde Park, New York, United States|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States|
|San Antonio Cancer Institute|
|San Antonio, Texas, United States|