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Combined Immunochemotherapy Followed By Reduced Dose Radiation Therapy (RT) for Patients With Newly Diagnosed Primary Central Nervous System Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00594815
First Posted: January 16, 2008
Last Update Posted: April 6, 2017
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.
Collaborators:
Northwestern Memorial Hospital
Columbia University
Kentuckiana Cancer Institute
University of Virginia
University of Vermont
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: February 13, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Lymphoma
Intervention: Drug: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine

  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 08/08/2002 Protocol Closed to Accrual 03/10/2009 Primary Completion Date 02-23-2016 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
No text entered.

Reporting Groups
  Description
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy

Participant Flow:   Overall Study
    Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma
STARTED   52 
COMPLETED   43 
NOT COMPLETED   9 
Never Treated                3 
Withdrawal by Subject                2 
Toxicity                4 



  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.
No text entered.

Reporting Groups
  Description
Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine: Immunochemotherapy

Baseline Measures
   Immunocompetent Pts With Newly Diagnosed Primary CNS Lymphoma 
Overall Participants Analyzed 
[Units: Participants]
 52 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      34  65.4% 
>=65 years      18  34.6% 
Age 
[Units: Years]
Median (Full Range)
 60 
 (30 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      22  42.3% 
Male      30  57.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Number of Participants Who Experienced Acute Treatment Related Adverse Events   [ Time Frame: 2 years ]

2.  Primary:   Progression Free Survival   [ 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. Antonio Omuro
Organization: Memorial Sloan Kettering Cancer Center
phone: 212-639-7523
e-mail: omuroa@mskcc.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00594815     History of Changes
Obsolete Identifiers: NCT00059956
Other Study ID Numbers: 01-146
First Submitted: January 7, 2008
First Posted: January 16, 2008
Results First Submitted: February 13, 2017
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017



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