Freiburg ZNS-NHL Study

University Hospital Freiburg

Status and phase: Unknown; Phase 2

Conditions: Primary Non Hodgkin Lymphoma of the Central Nervous System

Treatments: Drug: methotrexate; Drug: Cytarabine; Drug: Carmustin; Drug: Rituximab; Drug: Thiotepa

Study type: Interventional

Funder types: Other

Identifiers

NCT00647049

ZNS-00465

Details and patient eligibility

About

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].

Enrollment: 78 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

A

Experimental group

Description:

first diagnosis of PCNSL: combined chemotherapy with methotrexate

Treatment:

Drug: Thiotepa

Drug: Carmustin

Drug: Cytarabine

Drug: Rituximab

Drug: methotrexate

B

Experimental group

Description:

Patients with relapse or progressive disease of PCNSL after methotrexate containing chemotherapy

Treatment:

Drug: Thiotepa

Drug: Carmustin

Drug: Cytarabine

Drug: Rituximab