Epratuzumab and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier:
NCT00553501
First received: November 2, 2007
Last updated: September 11, 2014
Last verified: September 2014
Results First Received: June 26, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lymphoma
Interventions: Biological: epratuzumab
Biological: 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
Between March 2008 and July 2009, 60 participants were recruited.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant was deemed ineligible and excluded from all analyses per study design.

Reporting Groups
  Description
Epratuzumab Plus Rituximab

Induction Therapy (Month 1):

Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22

Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36


Participant Flow:   Overall Study
    Epratuzumab Plus Rituximab  
STARTED     59  
COMPLETED     55  
NOT COMPLETED     4  
Adverse Event                 2  
Death                 1  
Progression                 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
Epratuzumab Plus Rituximab

Induction Therapy (Month 1):

Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22

Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36


Baseline Measures
    Epratuzumab Plus Rituximab  
Number of Participants  
[units: participants]
  59  
Age  
[units: years]
Median ( Full Range )
  54  
  ( 32 to 90 )  
Gender  
[units: participants]
 
Female     35  
Male     24  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     54  
More than one race     0  
Unknown or Not Reported     2  
Region of Enrollment  
[units: participants]
 
United States     59  



  Outcome Measures
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1.  Primary:   Number of Participants With Overall Response   [ Time Frame: 12 months ]

2.  Secondary:   Progression Free Survival   [ Time Frame: Duration of study (up to 10 years) ]

3.  Post-Hoc:   3-Year Overall Survival   [ Time Frame: 3 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
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: Barbara Grant, MD
Organization: University of Vermont, Vermont Cancer Center
e-mail: barbara.grant@vtmednet.org


Publications of Results:

Responsible Party: Alliance for Clinical Trials in Oncology ( Cancer and Leukemia Group B )
ClinicalTrials.gov Identifier: NCT00553501     History of Changes
Other Study ID Numbers: CDR0000572604, U10CA031946, CALGB-50701
Study First Received: November 2, 2007
Results First Received: June 26, 2014
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration