primary Non-Hodgkin Lymphoma of the Central Nervous System (PCNSL), histologically confirmed Age: 18 - 65 years MedDRA version: 16.1 Level: PT Classification code 10029614 Term: Non-Hodgkin's lymphoma unspecified histology aggressive stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Methotrexat "Lederle" Lösung /solution
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: METHOTREXATE
CAS Number: 59052
Concentration unit: mg/m2 milligram(s)/square meter
Co
Sponsors
University Medical Center Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - group A: first diagnosis of PCNSL, histolgically 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - manifestations of further lymphoma outside the CNS - sero-positive for HIV - severe pulmonary, cardial, hepatic, renal impaiment - neutrophile count 1,5 mg% or creatinine-clearance 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, leukovorine, dexamethasone, neupogen and neulasta.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the efficacy of therapy with respect to the complete response rate 30 days after completion of the blood stem-cell transplantation ;Secondary Objective: 1. Evaluation of duration of repsonse 2. Evaluation of the global survival time 3. Evaluation of the efficacy of each part of the therapy 4. Evaluation of the therapy associated (neuro-) toxicity with special respect to the neuropsychological state in the course and after completion of the therapy 6. Safety and tolerability ;Primary end point(s): Assessment of the efficacy with respect to the complete response rate 30 days after completion of the blood stem-cell transplantation | — |
Countries
Germany
Outcome results
None listed