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

Study Overview
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Brief Summary
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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.

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

Conditions
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Primary Non Hodgkin Lymphoma of the Central Nervous System

Intervention / Treatment
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* Drug: Methotrexate
* Drug: Lomustine
* Drug: Procarbazine
* Drug: Rituximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Methotrexate|3g/m² i.v. max. 9 times|
|Drug: Lomustine|110 mg/m² p.o., max. 3 times|
|Drug: Procarbazine|60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times|
|Drug: Rituximab|375 mg/m² i.v., max. 10 times|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission rate |  | 30 days after end of immuno-chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCNSL, Lymphoma, Methotrexate, Lomustine, Procarbazine, Rituximab, Elderly, Chemotherapy