Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400685
• Other study ID #: 11-016
• Status: Completed
• Phase: Phase 1
• First received: April 11, 2011
• Last updated: January 23, 2018
• Start date: December 2012
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• B Chronic Lymphocytic Leukemia
• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Small Lymphocytic Lymphoma

Intervention

Drug:
• Lenalidomide
Lenalidomide will be dose escalated until the maximum tolerated dose is reached. The starting dose is 2.5mg, followed by 5mg, followed by 10mg.
• Bendamustine
90 mg/m^2 IV days 1-2 of each cycle for 6 cycles
• Rituximab
375 mg/m^2 IV day 1 (cycle 1), 500 mg/m^2 day 1 (cycles 2-6)

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL		2 years
Secondary	Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL		2 year
Secondary	Clinical efficacy	response rate, progression-free and overall survival	2 years