Status:
UNKNOWN
Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma
Lead Sponsor:
University Hospital Freiburg
Collaborating Sponsors:
Universitätsklinikum Köln
Ludwig-Maximilians - University of Munich
Conditions:
Primary Non Hodgkin Lymphoma of the Central Nervous System
Eligibility:
All Genders
65+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether combined chemotherapy \[rituximab plus high dosage methotrexate, lomustine, and procarbazine\] followed by maintenance therapy with procarbazine is ef...
Eligibility Criteria
Inclusion
- first diagnosis of PCNSL, histologically confirmed
- age \> 65 years
- written signed and dated informed consent of the legal representative and - if possible - of the patient
Exclusion
- manifestations of further lymphoma outside the CNS
- sero-positive for HIV
- severe pulmonary, cardiac, hepatic, renal impairment
- uncontrolled infection
- neutrophil count \< 1.500/µl, platelet count \< 100.000/µl
- pulmonary disease with IVC \< 55%, DLCO \< 40%
- cardiac ejection fraction \< 50%, uncontrolled malign arrhythmia
- creatinine \> 1,5 mg% or creatinine-clearance \< 50ml/min
- bilirubin \> 2mg/dl
- ascites or pleural effusion (\> 500ml)
- known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone
- participation in another clinical trial within the last 30 days prior to the begin or parallel to this study
- known or current drug or alcohol abuse
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00989352
Start Date
September 1 2009
End Date
September 1 2011
Last Update
October 5 2009
Active Locations (1)
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1
University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology
Freiburg im Breisgau, Germany, 79106