A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL). (RENEW)

This study has been terminated.
(Terminated by sponsor due to new unpublished data that rendered the current design of the study no longer clinically relevant. There were no safety concerns.)
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01021423
First received: November 25, 2009
Last updated: February 10, 2012
Last verified: February 2012
Results First Received: October 31, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Mantle Cell Lymphoma
Non-Hodgkin's Lymphoma
Interventions: Drug: Lenalidomide
Other: Placebo

  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
Randomization was stratified according to 1) the type of first-line induction chemotherapy (anthracycline-based, fludarabine-based, or rituximab-bendamustine combination therapy) and 2) the response to first-line induction chemotherapy (complete response or partial response).

Reporting Groups
  Description
Lenalidomide Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Placebo Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.

Participant Flow:   Overall Study
    Lenalidomide     Placebo  
STARTED     4 [1]   5 [2]
COMPLETED     0     0  
NOT COMPLETED     4     5  
Study terminated                 4                 5  
[1] One participant discontinued treatment (continued in the study) due to an AE
[2] One participant discontinued treatment (continued in the study) due to disease progression



  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 Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Placebo Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Total Total of all reporting groups

Baseline Measures
    Lenalidomide     Placebo     Total  
Number of Participants  
[units: participants]
  4     5     9  
Age  
[units: years]
Mean ± Standard Deviation
  77.8  ± 4.65     73.0  ± 6.89     75.1  ± 6.17  
Gender  
[units: participants]
     
Female     1     2     3  
Male     3     3     6  
Race (NIH/OMB)  
[units: 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     0     0     0  
White     4     5     9  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: participants]
     
Status = 0     4     3     7  
Status = 1     0     2     2  
Response of Mantle Cell Lymphoma (MCL) to chemotherapy at enrollment [2]
[units: participants]
     
Complete response     3     1     4  
Partial response     1     4     5  
[1] Category 0 = Fully active, able to carry on all pre-diseases performance without restriction; Category 1 = restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g. light housework, office work).
[2] Participants' response to first-line chemotherapy. Response evaluation was as defined by 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007). Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Partial response (PR) is defined as the regression of measurable disease and no appearance of new sites of disease. For full definitions, please refer to the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson 2007).



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS)   [ Time Frame: up to 7 years ]

2.  Secondary:   Overall Survival   [ Time Frame: up to 7 years ]

3.  Secondary:   Participants With Treatment Emergent Adverse Events (TEAEs)   [ Time Frame: up to 9 months ]

4.  Secondary:   Time to Progression   [ Time Frame: up to 7 years ]

5.  Secondary:   Time to Treatment Failure   [ Time Frame: up to 2 years ]

6.  Secondary:   Participants With a Tumor Response   [ Time Frame: up to 7 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
Study terminated early. Most analyses were not performed.


  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: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


No publications provided by Celgene Corporation

Publications automatically indexed to this study:

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01021423     History of Changes
Other Study ID Numbers: CC-5013-MCL-003
Study First Received: November 25, 2009
Results First Received: October 31, 2011
Last Updated: February 10, 2012
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Israeli Health Ministry Pharmaceutical Administration
Italy: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic