Methotrexate-based Chemo-immunotherapy Followed by Maintenance Therapy for Patients > 65 Years With Central Nervous System (CNS)-Lymphoma (PRIMAIN)

University Hospital Freiburg

Status and phase

Unknown

Phase 2

Conditions

Primary Non Hodgkin Lymphoma of the Central Nervous System

Treatments

Drug: Methotrexate

Drug: Procarbazine

Drug: Lomustine

Drug: Rituximab

Study type

Interventional

Funder types

Other

Identifiers

NCT00989352

Eudract: 2008-007645-31

00591

Details and patient eligibility

About

The purpose of this study is to determine whether combined chemotherapy [rituximab plus high dosage methotrexate, lomustine, and procarbazine] followed by maintenance therapy with procarbazine is effective in the treatment of cerebral Non Hodgkin lymphoma [PCNSL] in patients > 65 years.

Enrollment

56 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

first diagnosis of PCNSL, histologically confirmed
age > 65 years
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
uncontrolled infection
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)
known hypersensitivity against methotrexate, lomustine, procarbazine, rituximab, leukovorin, or dexamethasone
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