Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
This study is for patients with chronic lymphocytic leukemia (CLL) who have not yet received
any treatment for their disease.
Current therapy for this disease includes the use of combination chemotherapy regimens
containing Fludarabine and Rituximab, which have been found to be very effective for CLL. In
this study, subjects will receive Fludarabine and Rituximab. After 3 cycles or 6 cycles of
Fludarabine and Rituximab treatment, they will receive Lenalidomide. We are doing this
research because we are attempting to improve the response, or outcome, of Fludarabine and
Rituximab in previously untreated CLL patients. Lenalidomide is a drug that alters the immune
system and it may also interfere with the development of tiny blood vessels that help support
tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells.
Lenalidomide is approved by the Food and Drug Administration (FDA) for treatment of specific
types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients
with multiple myeloma (MM). MDS and MM are blood disorders that involve different types of
blood cells. It is not approved for chronic lymphocytic leukemia. It is currently being
tested in a variety of cancer conditions. In this case it is considered experimental.
This research is being done because we are attempting to find a better treatment for chronic
lymphocytic leukemia. We do not know the effect of Lenalidomide following the regimen of
Fludarabine and Rituximab.
The hypothesis of the study is that adding Lenalidomide after the standard treatment regimen
of Fludarabine and Rituximab will have better outcomes than treatment with Fludarabine and
Rituximab alone.