Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(This study was unsuccessful in enrolling the target number of subjects during the funding period.)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01465230
First received: October 28, 2011
Last updated: October 22, 2014
Last verified: October 2014
Results First Received: August 26, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Lymphocytic Leukemia
Intervention: Drug: Maintenance lenalidomide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lenalidomide

Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.

Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide


Participant Flow:   Overall Study
    Lenalidomide  
STARTED     2  
COMPLETED     0  
NOT COMPLETED     2  
Withdrawal by Subject                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lenalidomide

Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.

Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide


Baseline Measures
    Lenalidomide  
Number of Participants  
[units: participants]
  2  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     2  
Gender  
[units: participants]
 
Female     1  
Male     1  



  Outcome Measures

1.  Primary:   Response Rate   [ Time Frame: 36 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Terri Parker
Organization: Yale University
phone: 203-737-5312
e-mail: terri.parker@yale.edu


No publications provided


Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01465230     History of Changes
Other Study ID Numbers: 1105008515
Study First Received: October 28, 2011
Results First Received: August 26, 2014
Last Updated: October 22, 2014
Health Authority: United States: Institutional Review Board