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FCR and Bevacizumab in the Treatment of Relapsed Chronic Lymphocytic Leukemia (CLL)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00448019
First received: March 13, 2007
Last updated: October 5, 2015
Last verified: October 2015
Results First Received: July 13, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Lymphocytic Leukemia
Interventions: Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Rituximab
Drug: Bevacizumab

  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
Recruitment Period: February 23, 2007 to November 17, 2010. All recruitment done at The University of Texas MD Anderson Cancer Center.

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
FCR + Bevacizumab FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.

Participant Flow:   Overall Study
    FCR + Bevacizumab  
STARTED     64  
COMPLETED     57  
NOT COMPLETED     7  
Withdrawal by Subject                 3  
Disease progression                 1  
Death                 2  
Insurance Issues                 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.
Two participants included in the study demographics were registered but withdrew prior to receiving treatment.

Reporting Groups
  Description
FCR + Bevacizumab FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.

Baseline Measures
    FCR + Bevacizumab  
Number of Participants  
[units: participants]
  64  
Age  
[units: years]
Median (Full Range)
  62  
  (39 to 84)  
Gender  
[units: participants]
 
Female     13  
Male     51  
Region of Enrollment  
[units: participants]
 
United States     64  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (PFS) Rate   [ Time Frame: Baseline up to 5 years ]

2.  Secondary:   Number of Participants With Complete or Partial Response to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated Chronic Lymphocytic Leukemia (CLL)   [ Time Frame: Response assessed after three 4-week courses and after six courses, up to 24 weeks ]

3.  Secondary:   Overall Response Rate (ORR) to Fludarabine, Cyclophosphamide, Rituximab, and Bevacizumab Therapy in Previously Treated CLL   [ Time Frame: Response assessed after three 4-week courses and after six courses, up to 24 weeks ]


  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: MD Anderson Cancer Center Leukemia Department
Organization: The University of Texas (UT) MD Anderson Cancer Center
phone: 713-792-7734
e-mail: CR_Study_Registration@mdanderson.org


Publications of Results:

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00448019     History of Changes
Other Study ID Numbers: MDACC-2005-0992
NCI-2010-00591 ( Registry Identifier: NCI CTRP )
Study First Received: March 13, 2007
Results First Received: July 13, 2015
Last Updated: October 5, 2015
Health Authority: United States: Institutional Review Board