B Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Conditions
Keywords
CLL, Leukemia, Untreated, B-CLL, SLL
Brief summary
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.
Detailed description
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.
Interventions
DRUGLenalidomide
Lenalidomide will be dose escalated until the maximum tolerated dose is reached. The starting dose is 2.5mg, followed by 5mg, followed by 10mg.
DRUGBendamustine
90 mg/m\^2 IV days 1-2 of each cycle for 6 cycles
DRUGRituximab
375 mg/m\^2 IV day 1 (cycle 1), 500 mg/m\^2 day 1 (cycles 2-6)
Sponsors
Dana-Farber Cancer Institute
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL | 2 year | — |
| Clinical efficacy | 2 years | response rate, progression-free and overall survival |
Countries
United States
Outcome results
None listed