Study Stopped
This study was unsuccessful in enrolling the target number of subjects during the funding period.
Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Maintenance Therapy With Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
1 other identifier
interventional
2
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2011
CompletedFirst Posted
Study publicly available on registry
November 4, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedResults Posted
Study results publicly available
October 23, 2014
CompletedOctober 23, 2014
October 1, 2014
1.7 years
October 28, 2011
August 26, 2014
October 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
36 months
Study Arms (1)
lenalidomide
EXPERIMENTALMaintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Interventions
Eligibility Criteria
You may qualify if:
- Previous induction treatment with bendamustine and rituximab
- 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
You may not qualify if:
- Serious medical condition that would prevent treatment with lenalidomide
- Evidence of tumor lysis syndrome
- Any prior treatment with lenalidomide
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Celgene Corporationcollaborator
Study Sites (1)
Yale Cancer Center
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Terri Parker
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Terri L Parker, MD
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2011
First Posted
November 4, 2011
Study Start
March 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
October 23, 2014
Results First Posted
October 23, 2014
Record last verified: 2014-10