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

Sponsor

University Hospital Freiburg (Other)

Overall Status

Unknown status

CT.gov ID

NCT00989352

Collaborator

Universitätsklinikum Köln (Other), Ludwig-Maximilians - University of Munich (Other), University Hospital Heidelberg (Other), University Hospital Ulm (Other)

Enrollment

Location

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Non Hodgkin Lymphoma of the Central Nervous System	Drug: Methotrexate Drug: Lomustine Drug: Procarbazine Drug: Rituximab	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treatment of Patients Over 65 Years With Primary CNS Lymphoma: High-dose Methotrexate Combined With Chemo-immunotherapy Followed by Maintenance Therapy

Study Start Date :

Sep 1, 2009

Anticipated Primary Completion Date :

Jun 1, 2011

Anticipated Study Completion Date :

Sep 1, 2011

Outcome Measures

Primary Outcome Measures

Complete remission rate [30 days after end of immuno-chemotherapy]

Secondary Outcome Measures

Duration of response [within 5 years]
Overall survival time [within 5 years]
Neuropsychological state (according to Mini-Mental State and IPCG testing) [within 5 years]
(Serious) adverse events ([S]AEs) [within 30 days after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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