Freiburger Studie zur Behandlung von Primären ZNS-Lymphomen bei Patienten über 65 Jahre: Methotrexat-basierte Chemo-Immuntherapie mit anschließender Erhaltungstherapie- PRIMAIN-Studie - - PRIMAI

• Conditions: Patients with primary CNS Lymphoma; MedDRA version: 16.1Level: LLTClassification code 10036685Term: Primary central nervous system lymphomaSystem Organ Class: 100000004864

• Registration Number: EUCTR2008-007645-31-DE
• Lead Sponsor: niversity Medical Center Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-16
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

patients with newly diagnosed primary Non-Hodgkin Lymphoma (NHL) of the central nervous system (CNS), histologically confirmed
- patients aged over 65 years
- patient legally competent, physically or mentally able of giving consent
- written, signed and dated informed consent of the patient (if legally competent) or of the legal representative (if patient legally incompetent) after detailed information according to international guidelines.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- patients with systemic lymphoma manifestations
- HIV seropositive patients
- patients with severe pulmonary, cardial, hepatic or renal damage, which could seriously impair the feasability of cytoreductive therapy in a life-threatening way
-patients with severe infections, which could seriously impair the feasability of cytoreductive therapy in a life-threatening way
- patients with the following haematologic parameters: neutrophile count < 2.000/µl, platelet count < 100.000/µl
- patients with known intolerance against study medications or ingredients
- pregnancy or lactation period
-participation in another within the last 30 days prior to the begin or parallel to this study
- known or current alcohol or drug abuse

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective is a first evaluation of the efficacy of this treatment based on the rate of complete remissions 4 weeks after therapy completion.;Secondary Objective: 1.Evaluation of duration of remission<br>2.Evaluation of overall survival<br>3.Evaluation of therapy associated (neuro-)toxicity considering the course of neuropsychological assessment during therapy and after therapy completion. <br>4.Safety and tolerability<br>;Primary end point(s): Assessment of efficacy with respect to complete response (CR) 4 weeks (28 days i.e. day 25-35) after therapy completion