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Pentostatin, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Astex Pharmaceuticals
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00541034
First received: October 5, 2007
Last updated: January 9, 2017
Last verified: January 2017
Results First Received: January 9, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Leukemia
Lymphoma
Interventions: Biological: rituximab
Drug: cyclophosphamide
Drug: pentostatin

  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
All Patients All patients who received cyclophosphamide, pentostatin and rituximab

Participant Flow:   Overall Study
    All Patients
STARTED   49 
COMPLETED   46 
NOT COMPLETED   3 
Non-Compliance                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.
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Reporting Groups
  Description
All Patients All patients who received cyclophosphamide, pentostatin and rituximab

Baseline Measures
   All Patients 
Overall Participants Analyzed 
[Units: Participants]
 49 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      31  63.3% 
>=65 years      18  36.7% 
Gender 
[Units: Participants]
Count of Participants
 
Female      12  24.5% 
Male      37  75.5% 


  Outcome Measures

1.  Primary:   Overall Objective Response   [ Time Frame: 2 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. Renier Brentjens
Organization: Memorial Sloan Kettering Cancer Center
phone: 1212-639-7053
e-mail: brentjer@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00541034     History of Changes
Other Study ID Numbers: 05-051
P30CA008748 ( US NIH Grant/Contract Award Number )
MSKCC-05051
Study First Received: October 5, 2007
Results First Received: January 9, 2017
Last Updated: January 9, 2017