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Sponsored by: |
Genta Incorporated |
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Information provided by: | Genta Incorporated |
ClinicalTrials.gov Identifier: | NCT00021749 |
This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.
Condition | Intervention | Phase |
---|---|---|
Chronic Lymphocytic Leukemia CLL |
Drug: Oblimerson sodium, G3139 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia |
Estimated Enrollment: | 49 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | March 2003 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 | |
US Oncology | |
Dallas, Texas, United States |
Study ID Numbers: | GL208, G3139, Bcl-2 Antisense |
Study First Received: | August 3, 2001 |
Last Updated: | February 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00021749 |
Health Authority: | United States: Food and Drug Administration |
CLL Leukemia Chronic Cancer Adult Lymphocytic Genasense |
G3139 Genta Bcl-2 Antisense Oligonucleotide oblimerson |
Chronic lymphocytic leukemia Lymphatic Diseases Leukemia Leukemia, Lymphoid Immunoproliferative Disorders |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, B-cell, chronic Lymphoproliferative Disorders Leukemia, B-Cell |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |