Freiburg ZNS-NHL Study: Therapy for Patients With Primary Non-Hodgkin Lymphoma of the CNS - Sequential High Dosage Chemotherapy With Autologous Peripheral Blood Stem Cell Plantatio

Phase 2

• Conditions: Primary Non Hodgkin Lymphoma of the Central Nervous System; C83.3; Diffuse large B-cell lymphoma

• Registration Number: DRKS00003748
• Lead Sponsor: niversitätsklinikum FreiburgAbt. Med 1Hämatologie / Onkologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-04
• Study Completion: 2015-01-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

group A: first diagnosis of PCNSL, histologically 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

Exclusion Criteria

- Patients with manifestations of further lymphoma outside the CNS

- sero-positive for HIV

- severe pulmonary, cardiac, hepatic, renal impairment

Patients with the following heamtological parameters:
- 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)

- 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, medicinal drug or alcohol abuse

- known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab,
leukovorin, dexamethasone, neupogen and neulasta.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- Complete response rate; time frame: 30 days after blood stem cell transplantation<br>

Secondary Outcome Measures

Name	Time	Method
1. - Duration of response; time frame: within 5 years<br>2. - Overall survival time; time frame: within 5 years<br>3. .- Determination of efficacy by means of neuropsychological state according to Mini-Mental State; time frame: within 5 years<br>4. - Evaluation of therapy associated (neuro-)toxicity under consideration of neuropsychological assessment in the course and after termination of therapy; time frame: within 5 years<br>5. - (Serious) adverse events ([S]AEs); time frame: within 30 days after treatment<br>