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Fludarabine, Cyclophosphamide, and Rituximab in Treating Patients Who Have Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003659
First Posted: January 27, 2003
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: November 28, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Leukemia
Interventions: Biological: filgrastim
Biological: rituximab
Drug: cyclophosphamide
Drug: fludarabine phosphate

  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
Protocol Open to Accrual 09/08/1998 Protocol Closed to Accrual 06/14/2005 Primary Completion Date 05/12/2009 Recruitment Location is the medical clinic

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
Intermediate or High Risk Chronic Lymphocytic Leukemia This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.

Participant Flow:   Overall Study
    Intermediate or High Risk Chronic Lymphocytic Leukemia
STARTED   39 
COMPLETED   36 
NOT COMPLETED   3 
Withdrawal by Subject                3 



  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
Intermediate or High Risk Chronic Lymphocytic Leukemia This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.

Baseline Measures
   Intermediate or High Risk Chronic Lymphocytic Leukemia 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      30  76.9% 
>=65 years      9  23.1% 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.7  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  20.5% 
Male      31  79.5% 
Region of Enrollment 
[Units: Participants]
 
United States   39 


  Outcome Measures
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1.  Primary:   Overall Response Rate   [ Time Frame: 3 years ]

2.  Secondary:   Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease   [ Time Frame: 3 years ]

3.  Secondary:   Overall Survival Status   [ Time Frame: up to 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. David Scheinberg
Organization: Memorial-Sloan Kettering Cancer Center
phone: 646-888-2190
e-mail: scheinbd@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00003659     History of Changes
Other Study ID Numbers: 98-080
MSKCC-98080
NCI-G98-1483
First Submitted: November 1, 1999
First Posted: January 27, 2003
Results First Submitted: November 28, 2012
Results First Posted: December 31, 2012
Last Update Posted: October 24, 2017