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Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age

This study has been completed.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01011894
First received: November 9, 2009
Last updated: April 7, 2017
Last verified: April 2017
Results First Received: February 23, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia
Leukemia
Intervention: Drug: 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
Protocol Open to Accrual 11/6/2009, Protocol Closed to Accrual 2/26/2013, Primary Completion Date 2/23/2016, Recruitment location is the medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intermediate or High Risk Chronic Lymphocytic Leukemia This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.

Participant Flow:   Overall Study
    Intermediate or High Risk Chronic Lymphocytic Leukemia
STARTED   26 
COMPLETED   26 
NOT COMPLETED   0 



  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
Intermediate or High Risk Chronic Lymphocytic Leukemia This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.

Baseline Measures
   Intermediate or High Risk Chronic Lymphocytic Leukemia 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      0   0.0% 
>=65 years      26 100.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  34.6% 
Male      17  65.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2   7.7% 
White      24  92.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures

1.  Primary:   Best Response   [ Time Frame: 2 years ]


  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. Renier Brentjens
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-7053
e-mail: brentjer@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01011894     History of Changes
Other Study ID Numbers: 09-045
Study First Received: November 9, 2009
Results First Received: February 23, 2017
Last Updated: April 7, 2017