Patients with primary CNS Lymphoma MedDRA version: 16.1 Level: LLT Classification code 10036685 Term: Primary central nervous system lymphoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Methotrexat "Lederle" Lösung (solution)
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: METHOTREXATE
CAS Number: 7413345
Concentration unit: mg milligram(s)
Concentration t
Sponsors
University Medical Center Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 2. Evaluation of overall survival 3. Evaluation of therapy associated (neuro-)toxicity considering the course of neuropsychological assessment during therapy and after therapy completion. 4. Safety and tolerability ;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 | — |
Countries
Germany
Outcome results
None listed