Clinical trial NCT01400685: Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL
Official title: Lenalidomide in Combination With Bendamustine and Rituximab for Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma(CLL/SLL): a Phase I Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
B Chronic Lymphocytic Leukemia
Keywords: CLL
Leukemia
Untreated
B-CLL
SLL
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Dana-Farber Cancer Institute
First posted: 2011-07-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL
timeFrame: 2 years
Secondary outcomes:
measure: Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL
timeFrame: 2 year
measure: Clinical efficacy
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jeremy Abramson, M.D.
role: PRINCIPAL_INVESTIGATOR
References: