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Genasense™ (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects with Chronic Lymphocytic Leukemia
This study is currently recruiting patients.
Sponsored by: | Genta |
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Information provided by: | Genta |
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. GenasenseTM (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 | Treatment or Intervention |
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Chronic Lymphocytic Leukemia |
Drug: Oblimerson sodium, G3139 Drug: Fludarabine Drug: Rituximab |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Pilot Study of Genasense™ (Oblimersen Sodium, Bcl-2 Antisense Oligonucleotide), Fludarabine and Rituximab in Previously Treated and Untreated Subjects with Chronic Lymphocytic Leukemia
Expected Total Enrollment: 80
Study start: November 2003
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
Location and Contact Information
More Information
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
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