Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma

Phase 2

• Conditions: Primary Non Hodgkin Lymphoma of the Central Nervous System

• Registration Number: NCT00989352
• Lead Sponsor: University Hospital Freiburg

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 effective in the treatment of cerebral Non Hodgkin lymphoma \[PCNSL\] in patients \> 65 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Status Verified: 2009-10
• Study First Submitted: 2009-10-02
• Study First Submitted QC: 2009-10-02
• Last Update Submitted: 2009-10-02
• Study First Posted: 2009-10-05
• Last Update Posted: 2009-10-05
• Primary Completion: 2011-06
• Study Completion: 2011-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Complete remission rate	30 days after end of immuno-chemotherapy

Secondary Outcome Measures

Name	Time	Method
Duration of response	within 5 years
Overall survival time	within 5 years
Neuropsychological state (according to Mini-Mental State and IPCG testing)	within 5 years
(Serious) adverse events ([S]AEs)	within 30 days after treatment

Trial Locations

Locations (1)

University Medical Center Freiburg, Dept. of Internal Medicine I - Hematology and Oncology; 🇩🇪 Freiburg, Germany