ClinicalTrials.gov
ClinicalTrials.gov Menu

Rituximab in Treating Patients With Refractory or Relapsed Primary CNS Lymphoma

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.
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 at Johns Hopkins

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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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 ]

Measure Type Primary
Measure Title Radiographic Response
Measure Description it at any time point patient progresses no more scans are required, patient is off study
Time Frame 1 month, 2 months and then q3months  

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

Measured Values
   Rituximab Monotherapy 
Participants Analyzed   11 
Radiographic Response 
[Units: Participants]
 4 

No statistical analysis provided for Radiographic Response



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

Measure Type Secondary
Measure Title Progression-free Survival
Measure Description pt had MRI every 3 months
Time Frame pt had MRI q3months  

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

Measured Values
   Rituximab Monotherapy 
Participants Analyzed   12 
Progression-free Survival 
[Units: Days]
Median (95% Confidence Interval)
 57 
 (29 to 175) 

No statistical analysis provided for Progression-free Survival



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

Measure Type Secondary
Measure Title Overall Survival
Measure Description survival was evaluated q 2months
Time Frame 47 months  

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

Measured Values
   Rituximab Monotherapy 
Participants Analyzed   12 
Overall Survival 
[Units: Months]
Median (95% Confidence Interval)
 20.9 
 (2.9 to 47) 

No statistical analysis provided for Overall Survival



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

Measure Type Secondary
Measure Title Toxicity
Measure Description patients only received drug for 8 weeks
Time Frame 8 weeks - 2 cycles  

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

Measured Values
   Rituximab Monotherapy 
Participants Analyzed   12 
Toxicity 
[Units: Related episodes]
 4 

No statistical analysis provided for Toxicity




  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