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Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

Primary Purpose

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, B Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lenalidomide
Bendamustine
Rituximab
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring CLL, Leukemia, Untreated, B-CLL, SLL

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Dana-Farber Cancer Institute

Outcomes

Primary Outcome Measures

Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL

Secondary Outcome Measures

Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL
Clinical efficacy
response rate, progression-free and overall survival

Full Information

First Posted
April 11, 2011
Last Updated
January 23, 2018
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01400685
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, B Chronic Lymphocytic Leukemia
Keywords
CLL, Leukemia, Untreated, B-CLL, SLL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
CC-5013, Revlimid
Intervention Description
Lenalidomide will be dose escalated until the maximum tolerated dose is reached. The starting dose is 2.5mg, followed by 5mg, followed by 10mg.
Intervention Type
Drug
Intervention Name(s)
Bendamustine
Other Intervention Name(s)
Treanda, SDX 105
Intervention Description
90 mg/m^2 IV days 1-2 of each cycle for 6 cycles
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Rituxan, Mabthera
Intervention Description
375 mg/m^2 IV day 1 (cycle 1), 500 mg/m^2 day 1 (cycles 2-6)
Primary Outcome Measure Information:
Title
Identify the maximum tolerated dose of lenalidomide when combined with bendamustine and rituximab in CLL/SLL
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Define dose limiting toxicities of bendamustine, rituximab and lenalidomide in CLL
Time Frame
2 year
Title
Clinical efficacy
Description
response rate, progression-free and overall survival
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeremy Abramson, M.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02214
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL

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