Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00794820
First received: November 18, 2008
Last updated: July 13, 2016
Last verified: July 2016
Results First Received: July 13, 2016  
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 Phosphate
Drug: Cyclophosphamide
Drug: Rituximab

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment Period: 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-Multiple Dose Rituximab Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3

Participant Flow:   Overall Study
    FCR-Multiple Dose Rituximab  
STARTED     66  
COMPLETED     50  
NOT COMPLETED     16  
Adverse Event                 11  
Secondary Malignancies                 2  
Resistant Disease                 2  
Ineligible/Screen Failure                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
Of the 66 participants registered, one participant failed screening and therefore was not evaluable for toxicity or response.

Reporting Groups
  Description
FCR-Multiple Dose Rituximab Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3

Baseline Measures
    FCR-Multiple Dose Rituximab  
Number of Participants  
[units: participants]
  66  
Age  
[units: years]
Median (Full Range)
  58  
  (27 to 82)  
Gender  
[units: participants]
 
Female     13  
Male     53  
Region of Enrollment  
[units: participants]
 
United States     66  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Remission (CR) Rate of FCR3 in Treatment-naïve Participants With Chronic Lymphocytic Leukemia (CLL) at 6 Months   [ Time Frame: 6 months ]

2.  Secondary:   Remission Duration/Time to Progression (TTP)   [ Time Frame: 6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014. ]

3.  Secondary:   Overall Survival (OS) Rate   [ Time Frame: 6 months to disease progression, period covered up to 12 years following treatment; Data cutoff for analysis was October 2014. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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


Results Point of Contact:  
Name/Title: Susan O'Brien, MD/ Leukemia
Organization: University of Texas (UT) MD Anderson Cancer Center
phone: 1-877-632-6789
e-mail: CR_Study_Registration@mdanderson.org



Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00794820     History of Changes
Other Study ID Numbers: 2003-0591
NCI-2010-01220 ( Registry Identifier: NCI CTRP )
Study First Received: November 18, 2008
Results First Received: July 13, 2016
Last Updated: July 13, 2016
Health Authority: United States: Institutional Review Board