Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Prologue Research International
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00179673
First received: September 10, 2005
Last updated: November 6, 2013
Last verified: November 2013
Results First Received: August 9, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-Hodgkins Lymphoma
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
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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 Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.

Participant Flow:   Overall Study
    Lenalidomide  
STARTED     43  
Received Study Drug     43  
COMPLETED     0 [1]
NOT COMPLETED     43  
Adverse Event                 7  
Lack of Efficacy                 15  
Withdrawal by Subject                 3  
Death                 4  
Other Observations and options                 14  
[1] Completed refers to participants ongoing in the study at the time of analysis.



  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.
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Reporting Groups
  Description
Lenalidomide Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.

Baseline Measures
    Lenalidomide  
Number of Participants  
[units: participants]
  43  
Age  
[units: years]
Mean ± Standard Deviation
  64.6  ± 10.95  
Age, Customized  
[units: participants]
 
<65 years     24  
65 - 75     10  
>75 years     9  
Gender  
[units: participants]
 
Female     17  
Male     26  
Race/Ethnicity, Customized  
[units: participants]
 
White     37  
Black     4  
Hispanic     0  
Asian/Pacific Islander     1  
American Indian/Alaska Native     0  
Other = Unspecified     1  
NHL Duration  
[units: years]
Mean ± Standard Deviation
  5.6  ± 4.38  
Non-Hodgkin's Lymphoma (NHL) Histology [1]
[units: participants]
 
Follicular lymphoma grade 1 or 2     22  
Small Lymphocytic lymphoma     18  
Nodal marginal-zone B-cell lymphoma     2  
Extranodal marginal-zone B-cell type (MALT)     1  
Non-Hodgkin's Lymphoma (NHL)-Stage [1]
[units: participants]
 
Stage I     1  
Stage II     11  
Stage III     6  
Stage IV     25  
International Prognostic Index (IPI)] [2]
[units: participants]
 
Low (0 to 1)     14  
Low/Intermediate (2)     15  
High/Intermediate (3)     6  
High (4 to 5)     8  
Eastern Cooperative Oncology Group (ECOG) performance status [3]
[units: participants]
 
0 = fully active, no restrictions;     27  
1 = restricted but ambulatory and capable of light     12  
2 = ambulatory and capable of self care but unable     4  
[1]

I: The lymphoma is in only 1 lymph node area or 1 area of a single organ outside the lymph system.

II: The lymphoma is in 2 or more groups of lymph nodes on the same side of the diaphragm, or extends from a single group of node(s) into a nearby organ.

III: The lymphoma is found in lymph node areas on both sides of the diaphragm, or may also have spread into an area or organ next to the lymph nodes, the spleen, or both.

IV: The lymphoma has spread outside the lymph system into an organ that is not next to an involved node or has spread to bone marrow, liver, brain, spinal cord or the pleura.

[2]

A clinical tool to aid in predicting the prognosis of patients with NHL. One point is assigned for each of the following risk factors:

  • Age greater than 60 years
  • Stage III or IV disease
  • Elevated serum lactate dehydrogenase
  • ECOG performance status of 2, 3, or 4
  • 1 extranodal site

The sum of the points allotted correlates with the following risk groups:

Low risk (0-1 points): 5-year survival of 73%; Low-intermediate risk (2 points): 5-year survival of 51%; High-intermediate risk (3 points): 5-year survival of 43%; High risk (4-5 points): 5-year survival of 26%.

[3]

ECOG-Eastern Cooperative Oncology Group (ECOG) Performance Status is used by doctors and researchers to assess how a participant's disease is progressing, assess how the disease affects the daily living activities of the participant and determines appropriate treatment and prognosis.

0 = Fully Active (Most Favorable Activity); 1 = Restricted activity but ambulatory; 2 = Ambulatory but unable to carry out work activities; 3 = Limited Self-Care; 4 = Completely Disabled, No self-care (Least Favorable Activity)




  Outcome Measures
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1.  Primary:   Percentage of Participants With Response   [ Time Frame: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months ]

2.  Secondary:   Percentage of Participants With Tumor Control   [ Time Frame: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months ]

3.  Secondary:   The Duration of Response   [ Time Frame: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months ]

4.  Secondary:   Progression Free Survival (PFS)   [ Time Frame: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months ]

5.  Secondary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 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:  
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: Senior Manager, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


Publications of Results:

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00179673     History of Changes
Other Study ID Numbers: CC-5013-NHL-001
Study First Received: September 10, 2005
Results First Received: August 9, 2013
Last Updated: November 6, 2013
Health Authority: United States: Food and Drug Administration