Lenalidomide and Rituximab in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01145495
First received: June 15, 2010
Last updated: April 18, 2014
Last verified: January 2014
Results First Received: January 6, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Contiguous Stage II Grade 1 Follicular Lymphoma
Contiguous Stage II Grade 2 Follicular Lymphoma
Contiguous Stage II Grade 3 Follicular Lymphoma
Noncontiguous Stage II Grade 1 Follicular Lymphoma
Noncontiguous Stage II Grade 2 Follicular Lymphoma
Noncontiguous Stage II Grade 3 Follicular Lymphoma
Stage III Grade 1 Follicular Lymphoma
Stage III Grade 2 Follicular Lymphoma
Stage III Grade 3 Follicular Lymphoma
Stage IV Grade 1 Follicular Lymphoma
Stage IV Grade 2 Follicular Lymphoma
Stage IV Grade 3 Follicular Lymphoma
Interventions: Biological: rituximab
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
Between June 2010 and November 2011, 66 participants were recruited.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three participants did not receive protocol treatment and were dropped from all analyses.

Reporting Groups
  Description
Treatment (Lenalidomide, Rituximab)

Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.

>

> rituximab: Given IV

>

> lenalidomide: Given orally


Participant Flow:   Overall Study
    Treatment (Lenalidomide, Rituximab)  
STARTED     63  
COMPLETED     51  
NOT COMPLETED     12  
Adverse Event                 6  
Withdrawal by Subject                 5  
Disease progression after respone                 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
Treatment (Lenalidomide, Rituximab)

Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.

rituximab: Given IV

lenalidomide: Given orally


Baseline Measures
    Treatment (Lenalidomide, Rituximab)  
Number of Participants  
[units: participants]
  63  
Age  
[units: years]
Median ( Full Range )
  53  
  ( 32 to 79 )  
Gender  
[units: participants]
 
Female     32  
Male     31  
Region of Enrollment  
[units: participants]
 
United States     63  
Follicular Lymphoma International Prognostic Index (FLIPI) [1]
[units: participants]
 
0-1     19  
2     42  
Not reported     2  
[1]

Follicular Lymphoma International Prognostic Index (FLIPI) (abstracted from Solal-Céligny et al., Blood, 2004. 104(5): p. 1258-1265)

Factors (1 point for each variable present):

  • Age > 60y
  • Ann Arbor Stage III-IV (range I-IV, with III and IV indicating highest risk)
  • Hemoglobin level < 12 g/dL
  • Lactate dehydrogenase (LDH) level > upper limit of normal (ULN)
  • >= 4 nodal sites of disease

Risk category (factors):

  • Low risk (0 or 1)
  • Intermediate risk (2)
  • High risk (> 3)



  Outcome Measures

1.  Primary:   Number of Participants Who Achieved a Complete Response   [ Time Frame: At 12 months ]

2.  Secondary:   Toxicity of Study Treatment, Assessed by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Time to Disease Progression   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Time to Best Response   [ Time Frame: Up to 10 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
No text entered.


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Peter Martin, M.D.
Organization: Weill Cornell Medical College
e-mail: pem9019@med.cornell.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01145495     History of Changes
Other Study ID Numbers: NCI-2011-02047, NCI-2011-02047, CDR0000675161, CALGB 50803, CALGB-50803, U10CA031946
Study First Received: June 15, 2010
Results First Received: January 6, 2014
Last Updated: April 18, 2014
Health Authority: United States: Food and Drug Administration