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Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

This study has been terminated.
(slow accrual and lack of resources and priority due to combining 2 consortia)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00072449
First Posted: November 6, 2003
Last Update Posted: August 28, 2013
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):
Sidney Kimmel Comprehensive Cancer Center
Results First Submitted: June 14, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: Biological: rituximab

  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
Rituximab Monotherapy Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks

Participant Flow:   Overall Study
    Rituximab Monotherapy
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Radiographic Response   [ Time Frame: 1 month, 2 months and then q3months ]

2.  Secondary:   Progression-free Survival   [ Time Frame: pt had MRI q3months ]

3.  Secondary:   Overall Survival   [ Time Frame: 47 months ]

4.  Secondary:   Toxicity   [ Time Frame: 8 weeks - 2 cycles ]


  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
Study terminated early due to slow accrual and lack of resources and priority due to NCI mandate of combining two consortia. Unable to fully analyze the data, or objectives, not enough patients. Not able to do statistics


  More Information