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A Study to Evaluate Lenalidomide Combined With Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This study has been terminated.
(Business decision)
Sponsor:
Information provided by:
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00474188
First received: May 14, 2007
Last updated: August 27, 2009
Last verified: August 2009
Results First Received: June 30, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diffuse Large B-cell Lymphoma
Interventions: Drug: CC-5013 (lenalidomide)
Drug: dexamethasone

  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 in Combination With Dexamethasone Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.

Participant Flow:   Overall Study
    Lenalidomide in Combination With Dexamethasone  
STARTED     26  
COMPLETED     20 [1]
NOT COMPLETED     6  
Withdrawal by Subject                 1  
Study discontinued by sponsor                 5  
[1] Disease progression=15, adverse event=4, death=1



  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 in Combination With Dexamethasone Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.

Baseline Measures
    Lenalidomide in Combination With Dexamethasone  
Number of Participants  
[units: participants]
  26  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     16  
Age  
[units: years]
Mean ± Standard Deviation
  66.7  ± 11.42  
Gender  
[units: participants]
 
Female     10  
Male     16  
Region of Enrollment  
[units: participants]
 
Australia     4  
Canada     2  
United States     20  



  Outcome Measures
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1.  Primary:   Tumor Response Rate   [ Time Frame: One Year ]

2.  Secondary:   Tumor Control Rate   [ Time Frame: One Year ]

3.  Secondary:   Duration of Response   [ Time Frame: One year ]

4.  Secondary:   Time to Progression   [ Time Frame: One year ]

5.  Secondary:   Progression-free Survival   [ Time Frame: One year ]


  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
Study terminated prematurely as a business decision. Analyses of efficacy not conducted.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Robert Kinght, M.D.
Organization: Celgene Corporation
phone: 908-673-9749
e-mail: rknight@celgene.com


No publications provided


Responsible Party: Robert Knight, M.D., Celgene/sponsor
ClinicalTrials.gov Identifier: NCT00474188     History of Changes
Other Study ID Numbers: CC-5013-NHL-005
Study First Received: May 14, 2007
Results First Received: June 30, 2009
Last Updated: August 27, 2009
Health Authority: United States: Food and Drug Administration