Freiburger ZNS-NHL StudieTherapie für Patienten mit primären Non-Hodgkin Lymphomen des ZNS – Sequentielle Hochdosis-Chemotherapie mit autologer peripherer Blutstammzelltransplantation - Freiburger ZNS-NHL-Studie

• Conditions: primary Non-Hodgkin Lymphoma of the Central Nervous System (PCNSL), histologically confirmedAge: 18 - 65 years; MedDRA version: 16.1Level: PTClassification code 10029614Term: Non-Hodgkin's lymphoma unspecified histology aggressive stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2005-000615-99-DE
• Lead Sponsor: niversity Medical Center Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-13
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

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

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

- manifestations of further lymphoma outside the CNS
- sero-positive for HIV
- severe pulmonary, cardial, hepatic, renal impaiment
- neutrophile count < 2.000/µl, platelet count < 100.000/µl
- pulmonary disease with IVC < 55%, DLCO < 40%
- kardiac ejection fraction < 50%, uncontrolled maligne arrhythmia
- creatinine > 1,5 mg% or creatinine-clearance < 50ml/min
- bilirubin > 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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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<br>;Secondary Objective: 1. Evaluation of duration of repsonse<br>2. Evaluation of the global survival time<br>3. Evaluation of the efficacy of each part of the therapy<br>4. Evaluation of the therapy associated (neuro-) toxicity with special respect to the neuropsychological state in the course and after completion of the therapy<br>6. Safety and tolerability<br>;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<br>