Back to resultsMaintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Maintenance lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring chronic lymphocytic leukemia, maintenance therapy
Eligibility Criteria
Inclusion Criteria:
- Previous induction treatment with bendamustine and rituximab
- 18 or more years of age
- chronic lymphocytic leukemia
- ECOG performance status less than or equal to 2
- Absolute neutrophile count more than 1,000
- Platelet count more than 70,000
Exclusion Criteria:
- Serious medical condition that would prevent treatment with lenalidomide
- Evidence of tumor lysis syndrome
- Any prior treatment with lenalidomide
Sites / Locations
- Yale Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
lenalidomide
Arm Description
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Outcomes
Primary Outcome Measures
Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Secondary Outcome Measures
Full Information
NCT ID
NCT01465230
First Posted
October 28, 2011
Last Updated
October 22, 2014
Sponsor
Yale University
Collaborators
Celgene Corporation
1. Study Identification
Unique Protocol Identification Number
NCT01465230
Brief Title
Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Official Title
Maintenance Therapy With Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Terminated
Why Stopped
This study was unsuccessful in enrolling the target number of subjects during the funding period.
Study Start Date
March 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Celgene Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will determine whether or not Lenalidomide improves effectiveness of treatment for chronic lymphocytic leukemia following chemotherapy with two drugs commonly used to treat the disease (bendamustine and rituximab).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
chronic lymphocytic leukemia, maintenance therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lenalidomide
Arm Type
Experimental
Arm Description
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Intervention Type
Drug
Intervention Name(s)
Maintenance lenalidomide
Intervention Description
Daily maintenance treatment, oral lenalidomide
Primary Outcome Measure Information:
Title
Response Rate
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Previous induction treatment with bendamustine and rituximab
18 or more years of age
chronic lymphocytic leukemia
ECOG performance status less than or equal to 2
Absolute neutrophile count more than 1,000
Platelet count more than 70,000
Exclusion Criteria:
Serious medical condition that would prevent treatment with lenalidomide
Evidence of tumor lysis syndrome
Any prior treatment with lenalidomide
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terri L Parker, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
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