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| Sponsored by: |
Genta Incorporated |
| Information provided by: | Genta Incorporated |
| ClinicalTrials.gov Identifier: | NCT00078234 |
Purpose
The treatment combination of Rituxan® (rituximab) and fludarabine has previously been reported to produce a high percentage of responses with less toxicity than other combination treatments. However, some leukemia subjects continue to have leukemia despite treatment with these standard anticancer drug therapies, or they may work for only a short period of time. In some subjects, when the leukemia does not respond well to therapy the leukemia cells may be over-producing one or more proteins. One of these proteins is called Bcl-2. Bcl-2 is a protein that appears to protect cancer cells from being killed and thus lengthens the life of the cancer cells. Genasense® (oblimersen sodium) is a compound that blocks production of the Bcl-2 protein. By first lowering levels of Bcl-2, it is possible that chemotherapy drugs may work more effectively as a cancer treatment. Genasense® may also directly kill CLL cells. This study will test whether treating subjects with Genasense®, fludarabine and rituximab is safe and effective.
| Condition | Intervention | Phase |
|
Chronic Lymphocytic Leukemia |
Drug: Oblimersen sodium, G3139 Drug: Fludarabine Drug: Rituximab |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
| Drug Information available for: | Fludarabine Fludarabine monophosphate Rituximab Oblimersen sodium |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Pilot Study of Genasense® (G3139, Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated Subjects With Chronic Lymphocytic Leukemia |
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contacts and Locations| United States, District of Columbia | |||||
| Georgetown University Medical Center/Lombardi Cancer Center | |||||
| Washington, District of Columbia, United States, 20007 | |||||
| United States, New York | |||||
| Long Island Jewish Medical Center | |||||
| New Hyde Park, New York, United States, 11040 | |||||
| Roswell Park Cancer Institute | |||||
| Buffalo, New York, United States, 14263 | |||||
| Genta Incorporated |
More Information
Genta's website/ centerwatch.com - Trial # 54371 
  |
| Study ID Numbers: | GL217 |
| First Received: | February 20, 2004 |
| Last Updated: | April 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00078234 |
| Health Authority: | United States: Food and Drug Administration |
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