Status:
UNKNOWN
Freiburg ZNS-NHL Study
Lead Sponsor:
University Hospital Freiburg
Collaborating Sponsors:
University Hospital Tuebingen
Conditions:
Primary Non Hodgkin Lymphoma of the Central Nervous System
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether combined chemotherapy \[rituximab plus high dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosa...
Eligibility Criteria
Inclusion
- group A: first diagnosis of PCNSL, histologically confirmed
- group B: relapse or progression of PCNSL after MTX containing chemotherapy
- age 18 - 65 years
- not legally incompetent, physically or mentally incapable of giving consent
- 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
- neutrophil count \< 2.000/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)
- pregnancy o r lactation
- women with childbearing potential without sufficient contraception
- 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
- known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab, leukovorin, dexamethasone, neupogen and neulasta.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2013
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00647049
Start Date
January 1 2007
End Date
August 1 2013
Last Update
November 17 2009
Active Locations (1)
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1
University Hospital Freiburg
Freiburg im Breisgau, Germany, 79106