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Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia (CLL) Age 65 and Older

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ClinicalTrials.gov Identifier: NCT00535873
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : September 2, 2013
Last Update Posted : August 21, 2018
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Leukemia
CLL
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Intervention: Drug: Lenalidomide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 10/3/2007 through 7/10/2009. All participants recruited at The University of Texas (UT) MD Anderson Cancer Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Sixty-one participants were registered and signed consent for this study. One participant signed consent but never received study medication.

Reporting Groups
  Description
Lenalidomide Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.

Participant Flow:   Overall Study
    Lenalidomide
STARTED   60 
COMPLETED   60 
NOT COMPLETED   0 



  Baseline Characteristics

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.
One of the sixty-one participants who signed consent did not receive study medication and was not included in the analysis for this study.

Reporting Groups
  Description
Lenalidomide Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.

Baseline Measures
   Lenalidomide 
Overall Participants Analyzed 
[Units: Participants]
 60 
Age 
[Units: Years]
Median (Full Range)
 71 
 (66 to 85) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      26  43.3% 
Male      34  56.7% 
Region of Enrollment 
[Units: Participants]
 
United States   60 


  Outcome Measures

1.  Primary:   Overall Response Rate (ORR)   [ Time Frame: From 3 cycles (90 days) up to 6 cycles (approximately 180 days) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alessandra Ferrajoli, MD/Associate Professor
Organization: The University of Texas M D Anderson Cancer Center
phone: 713-792-2063
e-mail: eharriso@mdanderson.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00535873     History of Changes
Other Study ID Numbers: 2006-0715
First Submitted: September 25, 2007
First Posted: September 26, 2007
Results First Submitted: June 19, 2013
Results First Posted: September 2, 2013
Last Update Posted: August 21, 2018