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Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

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ClinicalTrials.gov Identifier: NCT00072449
Recruitment Status : Terminated (slow accrual and lack of resources and priority due to combining 2 consortia)
First Posted : November 6, 2003
Results First Posted : August 28, 2013
Last Update Posted : August 28, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: Biological: rituximab

  Participant Flow

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

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

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