Genasense® (Oblimersen Sodium), Fludarabine, and Rituximab in Subjects With Chronic Lymphocytic Leukemia
Status:
Completed
Trial end date:
2010-09-01
Target enrollment:
Participant gender:
Summary
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.