Freiburg ZNS-NHL Study
Conditions
Primary Non Hodgkin Lymphoma of the Central Nervous System
Conditions: official terms
Lymphoma, Non-Hodgkin
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: methotrexate Type: Drug
Name: Rituximab Type: Drug
Name: Cytarabine Type: Drug
Name: Thiotepa Type: Drug
Name: Carmustin Type: Drug
Overall Status
Recruiting
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].
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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.
Location
University Hospital Freiburg
Freiburg, Germany
Status: Recruiting
Contact: Gerald Illerhaus, Dr. - 00497612703785 - Gerald.Illerhaus@uniklinik-freiburg.de
Start Date
January 2007
Completion Date
August 2013
Sponsors
University Hospital Freiburg
Source
University Hospital Freiburg
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page