Lenalidomide With or Without Rituximab After Standard Chemotherapy in Treating Patients With Diffuse Large B-Cell Non-Hodgkin Lymphoma

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Nishitha Reddy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00765245
First received: October 1, 2008
Last updated: March 10, 2016
Last verified: March 2016
Results First Received: February 27, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Drug: Lenalidomide
Drug: Rituximab

  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
This study began enrolling patients October 2008 and continued until November 2013 when its study accrual goal was met. Patients were recruited from two academic medical institutions, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center and the University of North Carolina Medical Center, Chapel Hill.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Fifty-one patients signed consent to participate in this trial. Seven patients did not meet eligibility criteria, thus they did not receive treatment therapy and continue on study.

Reporting Groups
  Description
Arm I: Lenalidomide Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Lenalidomide and Rituximab IV

Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles

Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization.


Participant Flow:   Overall Study
    Arm I: Lenalidomide     Arm II: Lenalidomide and Rituximab IV  
STARTED     22     22  
COMPLETED     9     20  
NOT COMPLETED     13     2  
disease progression                 3                 2  
Withdrawal by Subject                 3                 0  
Adverse Event                 5                 0  
Physician Decision                 1                 0  
Death                 1                 0  



  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
Arm I: Lenalidomide Lenalidomide: Orally once daily on days 1-21. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.
Arm II: Lenalidomide and Rituximab IV

Patients receive lenalidomide as in arm I and rituximab IV on day 8 of courses 1, 3, 5, 7, 9, and 11 in the absence of disease progression or unacceptable toxicity.

Lenalidomide: Lenalidomide 20 mg daily, Days 1-21, followed by 7 days rest (28-day cycle). Cycles will be repeated every 28 days for a total of 12 cycles

Rituximab: Rituximab 375 mg/m2 intravenously (IV) starting on Day 8, Cycle 1 of lenalidomide. Rituximab will be repeated on Day 8 of odd numbered cycles (Cycles 1, 3, 5, 7, 9, and 11) for a total of 6 doses from randomization.

Total Total of all reporting groups

Baseline Measures
    Arm I: Lenalidomide     Arm II: Lenalidomide and Rituximab IV     Total  
Number of Participants  
[units: participants]
  22     22     44  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     15     17     32  
>=65 years     7     5     12  
Age  
[units: years]
Median (Inter-Quartile Range)
  60   (54.8 to 69.5)     59.0   (49.5 to 62.5)     59   (52 to 65)  
Gender  
[units: participants]
     
Female     12     9     21  
Male     10     13     23  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     1     1  
Not Hispanic or Latino     20     18     38  
Unknown or Not Reported     2     3     5  
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     1     2     3  
White     19     18     37  
More than one race     1     0     1  
Unknown or Not Reported     1     2     3  
Region of Enrollment  
[units: participants]
     
United States     22     22     44  



  Outcome Measures
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1.  Primary:   Disease-free Survival at 1 Year   [ Time Frame: From on-treatment date to disease recurrence, up to 1 year ]

2.  Secondary:   Disease-free Survival at 2 Years   [ Time Frame: From on-treatment date to disease recurrence, up to 2 years ]

3.  Secondary:   Number of Patients With Each Worst‐Grade Toxicity   [ Time Frame: 30 days after completing treatment, for up to 13 months ]

4.  Other Pre-specified:   Investigate Potential Predictive Biomarkers of Clinical Response or Resistance to Lenalidomide   [ Time Frame: up to two years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Other Pre-specified:   Exploratory: Concordance Between IHC for GCB and Non-GCB Subtypes to the Gene Expression Profiles Associated With the Subtypes   [ Time Frame: up to two 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
"Pre-specified Outcomes Measures" data were not collected as anticipated in original protocol, thus results will not be reported.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Nishitha Reddy
Organization: Vanderbilt-Ingram Cancer Center
phone: 800-811-8480
e-mail: nishitha.reddy@vanderbilt.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Nishitha Reddy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT00765245     History of Changes
Other Study ID Numbers: VICC HEM 0835
P30CA068485 ( US NIH Grant/Contract Award Number )
Study First Received: October 1, 2008
Results First Received: February 27, 2015
Last Updated: March 10, 2016
Health Authority: United States: Food and Drug Administration