Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 1/27/2018 |
| Start Date: | December 2012 |
| End Date: | January 2018 |
Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study
Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify
or regulate the functioning of the immune system. It is an FDA approved drug for people with
multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL),
but it does appear effective in CLL when used alone, and is being studied for use in
combination with chemotherapy in this and other lymphomas and leukemias.
In this research study we are hoping to learn more about the effects of lenalidomide on CLL
when given in combination with bendamustine and rituximab, which is a highly effective
regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest
dose of lenalidomide that can be given safely, without causing any serious or unmanageable
side effects.
or regulate the functioning of the immune system. It is an FDA approved drug for people with
multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL),
but it does appear effective in CLL when used alone, and is being studied for use in
combination with chemotherapy in this and other lymphomas and leukemias.
In this research study we are hoping to learn more about the effects of lenalidomide on CLL
when given in combination with bendamustine and rituximab, which is a highly effective
regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest
dose of lenalidomide that can be given safely, without causing any serious or unmanageable
side effects.
Subjects will receive lenalidomide, bendamustine and rituximab in cycles of 28 days (4
weeks). Lenalidomide will be administered orally once daily on days 8-21 of cycle 1 and on
days 1-21 of all subsequent cycles. Bendamustine will be administered through a vein (IV
infusion) on days 1 and 2 of each cycle. Rituximab will be administered as an IV infusion on
day 1 of each cycle.
Subjects will receive routine blood tests and physical exam during each cycle. Tumor
assessments by CT scan will be performed during cycles 2, 4, and 6.
weeks). Lenalidomide will be administered orally once daily on days 8-21 of cycle 1 and on
days 1-21 of all subsequent cycles. Bendamustine will be administered through a vein (IV
infusion) on days 1 and 2 of each cycle. Rituximab will be administered as an IV infusion on
day 1 of each cycle.
Subjects will receive routine blood tests and physical exam during each cycle. Tumor
assessments by CT scan will be performed during cycles 2, 4, and 6.
Inclusion Criteria:
- Diagnosed with B-cell CLL or SLL (chronic lymphocytic leukemia or small lymphocytic
leukemia)
- Life expectancy > 3 months
- Organ and marrow function with protocol parameters
- Able to take aspirin daily
Exclusion Criteria:
- Age >80 years
- Prior systemic therapy for CLL/SLL including chemotherapy or antibody therapy
- Pregnant or breast-feeding
- Serious medical condition, laboratory abnormality, or psychiatric illness that would
prevent the subject from signing informed consent
- Known hypersensitivity to thalidomide or lenalidomide
- Prior use of lenalidomide
- Concurrent use of other anti-cancer agents or treatments
- HIV positive
- Prior history of another malignancy unless disease free for at least 2 years
- Uncontrolled intercurrent illness
We found this trial at
2
sites
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