Freiburg ZNS-NHL Study

Phase 2

• Conditions: Primary Non Hodgkin Lymphoma of the Central Nervous System
• Interventions: Drug: methotrexate; Drug: Rituximab; Drug: Cytarabine; Drug: Thiotepa; Drug: Carmustin

• Registration Number: NCT00647049
• Lead Sponsor: University Hospital Freiburg

Brief Summary

The purpose of this study is to determine whether combined chemotherapy \[rituximab plus high dosage methotrexate (max. 2 cycles) followed by arabinoside/thiotepa (max. 2 cycles) followed by high dosage carmustin/thiotepa\] followed by peripheral blood stem cell transplantation is effective in the treatment of cerebral Non Hodgkin lymphoma \[PCNSL\].

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-03-26
• Study First Submitted QC: 2008-03-28
• Study First Posted: 2008-03-31
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-16
• Last Update Posted: 2009-11-17
• Primary Completion: 2013-05
• Study Completion: 2013-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

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

• manifestations of further lymphoma outside the CNS
• sero-positive for HIV
• severe pulmonary, cardiac, hepatic, renal impairment
• neutrophil count < 2.000/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 or alcohol abuse
• known hypersensitivity against methotrexate, cytarabine, thiotepa, BCNU rituximab, leukovorin, dexamethasone, neupogen and neulasta.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	Rituximab	first diagnosis of PCNSL: combined chemotherapy with methotrexate
A	Cytarabine	first diagnosis of PCNSL: combined chemotherapy with methotrexate
A	Carmustin	first diagnosis of PCNSL: combined chemotherapy with methotrexate
B	Carmustin	Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
A	methotrexate	first diagnosis of PCNSL: combined chemotherapy with methotrexate
A	Thiotepa	first diagnosis of PCNSL: combined chemotherapy with methotrexate
B	Thiotepa	Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
B	Cytarabine	Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy
B	Rituximab	Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy

Primary Outcome Measures

Name	Time	Method
Complete response rate	30 days after blood stem cell transplantation

Secondary Outcome Measures

Name	Time	Method
Duration of response	within 5 years
Overall survival time	within 5 years
Neuropsychological state according to Mini-Mental State	within 5 years
Neuropsychological assessment (digit span, Hopkins verbal Learning Test-Revised, Trials 1-3, Brief Test of Attention, Trial Making Test, Grooved Pegboard, 6. HVLT-R , EORTC L C30 , EORTC BN20)	within 5 years
(Serious) adverse events ([S]AEs)	within 30 days after treatment

Trial Locations

Locations (1)

University Hospital Freiburg; 🇩🇪 Freiburg, Germany