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Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01465230
Recruitment Status : Terminated (This study was unsuccessful in enrolling the target number of subjects during the funding period.)
First Posted : November 4, 2011
Results First Posted : October 23, 2014
Last Update Posted : October 23, 2014
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE October 28, 2011
First Posted Date  ICMJE November 4, 2011
Results First Submitted Date  ICMJE August 26, 2014
Results First Posted Date  ICMJE October 23, 2014
Last Update Posted Date October 23, 2014
Study Start Date  ICMJE March 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2014)
Response Rate [ Time Frame: 36 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2011)
Response Rate [ Time Frame: 36 months ]
NCI sponsored Working Group Guidelines for CLL
Change History Complete list of historical versions of study NCT01465230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2011)
Adverse events [ Time Frame: 36 months ]
Physical examination, blood counts.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Maintenance Therapy: Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
Official Title  ICMJE Maintenance Therapy With Lenalidomide Following Bendamustine and Rituximab Induction Therapy for Chronic Lymphocytic Leukemia
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Lymphocytic Leukemia
Intervention  ICMJE Drug: Maintenance lenalidomide
Daily maintenance treatment, oral lenalidomide
Study Arms  ICMJE Experimental: lenalidomide
Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.
Intervention: Drug: Maintenance lenalidomide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 12, 2014)
2
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2011)
37
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01465230
Other Study ID Numbers  ICMJE 1105008515
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE
Principal Investigator: Terri L Parker, MD Yale University
PRS Account Yale University
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP