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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00003659
First received: November 1, 1999
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
Results First Received: November 28, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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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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  
Number of Participants  
[units: participants]
 		  39  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     9  
Age  
[units: years]
Mean ± Standard Deviation 		  57.7  ± 8.8  
Gender  
[units: participants]
 		 
Female     8  
Male     31  
Region of Enrollment  
[units: participants]
 		 
United States     39  



  Outcome Measures
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1.  Primary:   Overall Response Rate   [ Time Frame: 3 years ]
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2.  Secondary:   Utilize Flow Cytometry and Polymerase Chain Reaction as Sensitive Measures of Minimal Residual Disease   [ Time Frame: 3 years ]
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3.  Secondary:   Overall Survival Status   [ Time Frame: up to 5 years ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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


No publications provided


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
Study First Received: November 1, 1999
Results First Received: November 28, 2012
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board