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

Phase 2

• Conditions: primär cerebrales Lymphom

• Registration Number: DRKS00000582
• Lead Sponsor: niversitätsklinikum Freiburg- vertreten durch:Leitenden Ärztlichen Direktor

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-29
• Study Completion: 2015-05-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 112

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: Not specified

Primary Outcome Measures

Name	Time	Method
Complete remission rate [ Time Frame: 30 days after end of immuno-chemotherapy ]

Secondary Outcome Measures

Name	Time	Method
1. Duration of response [ Time Frame: within 5 years ] [ Designated as safety issue: No ]<br> 2.Overall survival time [ Time Frame: within 5 years ] [ Designated as safety issue: No ]<br> 3. Neuropsychological state (according to Mini-Mental State and IPCG testing) [ Time Frame: within 5 years ] [ Designated as safety issue: Yes ]<br> 4. (Serious) adverse events ([S]AEs) [ Time Frame: within 30 days after treatment ] [ Designated as safety issue: Yes ]