Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)

This study has been completed.
Sponsor:
Collaborator:
Prologue Research International
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00179660
First received: September 13, 2005
Last updated: June 25, 2013
Last verified: June 2013
Results First Received: June 25, 2013  
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: 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
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 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     50  
Received Study Drug     49  
Completed 12 Cycles of Treatment     12  
COMPLETED     0 [1]
NOT COMPLETED     50  
Adverse Event                 7  
Lack of therapeutic effect                 28  
Withdrawal by Subject                 2  
Lost to Follow-up                 1  
Death                 3  
Other - Unspecified                 9  
[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.
Intent to treat population includes all participants who received at least 1 dose of study drug.

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]
  49  
Age  
[units: years]
Mean ± Standard Deviation
  64.8  ± 11.53  
Gender  
[units: participants]
 
Female     24  
Male     25  
Race/Ethnicity, Customized  
[units: participants]
 
White     36  
Black     2  
Hispanic     10  
Asian/Pacific Islander     1  
Region of Enrollment  
[units: participants]
 
United States     49  
Eastern Cooperative Oncology Group (ECOG) performance status [1]
[units: participants]
 
0     20  
1     23  
2     5  
Missing     1  
Non-Hodgkin's Lymphoma (NHL) Stage [2]
[units: participants]
 
Stage I     1  
Stage II     7  
Stage III     9  
Stage IV     32  
NHL histology  
[units: participants]
 
Follicular lymphoma grade 3     5  
Diffuse large B-cell lymphoma     26  
Mantle cell lymphoma     15  
Transformed     3  
NHL Duration  
[units: years]
Mean ± Standard Deviation
  4.0  ± 4.91  
International Prognostic Index (IPI) [3]
[units: participants]
 
Low (0 to 1)     8  
Low/Intermediate (2)     22  
High/Intermediate (3)     13  
High (4 to 5)     6  
[1] 0 = fully active, no restrictions; 1 = restricted but ambulatory and capable of light work; 2 = ambulatory and capable of self care but unable to work.
[2]

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.

[3]

A clinical tool to aid in predicting the prognosis of patients with aggressive 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%




  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 3.7 months, with a maximum of 32.5 months. ]

2.  Secondary:   Percentage of Participants With Tumor Control   [ Time Frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months. ]

3.  Secondary:   Duration of Response   [ Time Frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months. ]

4.  Secondary:   Duration of Tumor Control   [ Time Frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months. ]

5.  Secondary:   Progression-free Survival   [ Time Frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months. ]

6.  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 15.2 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: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
phone: 1-888-260-1599
e-mail: clinicaltrialdisclosure@celgene.com


Publications of Results:
Peter H. Wiernik, Izidore S. Lossos, Joseph M. Tuscano, Glen Justice, Julie M. Vose, Craig E. Cole, Wendy Lam, Kyle McBride, Kenton Wride, Dennis Pietronigro, Kenichi Takeshita, Annette Ervin-Haynes, Jerome B. Zeldis, and Thomas M. Habermann. Lenalidomide Monotherapy in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma. Journal of Clinical Oncology 26:4952-4957, 2008.


Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00179660     History of Changes
Other Study ID Numbers: CC-5013-NHL-002
Study First Received: September 13, 2005
Results First Received: June 25, 2013
Last Updated: June 25, 2013
Health Authority: United States: Food and Drug Administration