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FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients

This study has been completed.
Sponsor:
Collaborators:
Biogen Idec
Genentech, Inc.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00090051
First received: August 23, 2004
Last updated: May 29, 2013
Last verified: May 2013
Results First Received: December 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Lymphocytic Leukemia
Interventions: Drug: Rituximab
Drug: Fludarabine Phosphate
Drug: Cyclophosphamide

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Fludarabine+Cyclophosphamide (FC) Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
Fludarabine+Cyclophosphamide+Rituximab (FCR) Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.

Participant Flow:   Overall Study
    Fludarabine+Cyclophosphamide (FC)     Fludarabine+Cyclophosphamide+Rituximab (FCR)  
STARTED     276     276  
Safety Population; Received Study Drug     272     274  
COMPLETED     167 [1]   181 [1]
NOT COMPLETED     109     95  
[1] Completed 6 Cycles of Treatment



  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.
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Reporting Groups
  Description
Fludarabine+Cyclophosphamide (FC) Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
Fludarabine+Cyclophosphamide+Rituximab (FCR) Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
Total Total of all reporting groups

Baseline Measures
    Fludarabine+Cyclophosphamide (FC)     Fludarabine+Cyclophosphamide+Rituximab (FCR)     Total  
Number of Participants  
[units: participants]
  276     276     552  
Age  
[units: Years]
Mean ± Standard Deviation
  61.3  ± 9.11     62.1  ± 9.17     61.7  ± 9.14  
Gender  
[units: Participants]
     
Female     95     89     184  
Male     181     187     368  



  Outcome Measures
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1.  Primary:   Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)   [ Time Frame: Mean observation time at time of analysis was approximately 26 months ]

2.  Primary:   Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)   [ Time Frame: Mean observation time at time of analysis was approximately 26 months ]

3.  Primary:   Final Analysis: Time to Progression-Free Survival Event   [ Time Frame: Median observation time was approximately 5 years ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Mean observation time at time of analysis was approximately 26 months ]

5.  Secondary:   Number of Participants With Overall Survival (OS) Events   [ Time Frame: Mean observation time at time of analysis was approximately 26 months ]

6.  Secondary:   Event-free Survival (EFS)   [ Time Frame: Mean observation time at time of analysis was approximately 26 months ]

7.  Secondary:   Number of Participants With Event-free Survival (EFS) Events   [ Time Frame: Mean observation time at time of analysis was approximately 26 months ]

8.  Secondary:   Disease-free Survival (DFS)   [ Time Frame: Mean observation time at time of analysis was approximately 26 months ]

9.  Secondary:   Number of Participants With Disease-free Survival (DFS) Events   [ Time Frame: Mean observation time at time of analysis was approximately 26 months ]

10.  Secondary:   Final Analysis: Time to Overall Survival Event   [ Time Frame: Median observation time was approximately 5 years ]

11.  Secondary:   Final Analysis: Time to Event-Free Survival Event   [ Time Frame: Median observation time was approximately 5 years ]

12.  Secondary:   Final Analysis: Percentage of Participants With Complete Response   [ Time Frame: Median observation time was approximately 5 years ]

13.  Secondary:   Final Analysis: Time to Disease-Free Survival Event   [ Time Frame: Median observation time was approximately 5 years ]

14.  Secondary:   Final Analysis: Duration of Response   [ Time Frame: Median observation time was approximately 5 years ]

15.  Secondary:   Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment   [ Time Frame: Median observation time was approximately 5 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
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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: Medical Communications
Organization: Hoffmann-La Roche
e-mail: global.clinical_trial_registry@roche.com


No publications provided by Hoffmann-La Roche

Publications automatically indexed to this study:

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00090051     History of Changes
Other Study ID Numbers: 102-14, BO17072
Study First Received: August 23, 2004
Results First Received: December 22, 2009
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration