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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00989352

Acronym

PRIMAIN

Enrollment

Registered

2009-10-05

Start date

2009-09-30

Completion date

2011-09-30

Last updated

2009-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Non Hodgkin Lymphoma of the Central Nervous System

Keywords

PCNSL, Lymphoma, Methotrexate, Lomustine, Procarbazine, Rituximab, Elderly, Chemotherapy

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.

Interventions

DRUGMethotrexate

3g/m² i.v. max. 9 times

DRUGLomustine

110 mg/m² p.o., max. 3 times

DRUGProcarbazine

60 mg/m² p.o. for 10 days, max. 3 times 100 mg p.o. for 5 days, max. 6 times

DRUGRituximab

375 mg/m² i.v., max. 10 times

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Complete remission rate	30 days after end of immuno-chemotherapy

Secondary

Measure	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

Countries

Germany

Contacts

Primary ContactGerald Illerhaus, PD Dr.

Gerald.Illerhaus@uniklinik-freiburg.de+497612703785

Backup ContactElvira Burger

elvira.burger@uniklinik-freiburg.de+497612707378

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026