Freiburg ZNS-NHL Study

• Status: Unknown status
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

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].

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Freiburg
• Collaborator: University Hospital Tuebingen
• Treatments: Cytarabine; Methotrexate; Rituximab; Thiotepa

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.