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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00000582

Enrollment

112

Registered

2010-10-29

Start date

2010-10-09

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

primär cerebrales Lymphom

Interventions

Group 1: day -6: Rituximab 375mg/m² R-MPL - day 1, 15, 29 Rituximab 375mg/m² - day 2, 16, 30 MTX 3000 mg/m² 4h i.v. - Leukovorinrescue 24h after start of MTX - day 2: Lomustin 110 mg/m² p.o

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

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

Exclusion criteria: * manifestations of further lymphoma outside the CNS * sero-positive for HIV * severe pulmonary, cardiac, hepatic, renal impairment * uncontrolled infection * neutrophil count 1,5 mg% or creatinine-clearance 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 [ Time Frame: 30 days after end of immuno-chemotherapy ]	—

Secondary

Measure	Time frame
1. Duration of response [ Time Frame: within 5 years ] [ Designated as safety issue: No ] 2.Overall survival time [ Time Frame: within 5 years ] [ Designated as safety issue: No ] 3. Neuropsychological state (according to Mini-Mental State and IPCG testing) [ Time Frame: within 5 years ] [ Designated as safety issue: Yes ] 4. (Serious) adverse events ([S]AEs) [ Time Frame: within 30 days after treatment ] [ Designated as safety issue: Yes ]	—

Measure

Time frame

1. Duration of response [ Time Frame: within 5 years ] [ Designated as safety issue: No ] 2.Overall survival time [ Time Frame: within 5 years ] [ Designated as safety issue: No ] 3. Neuropsychological state (according to Mini-Mental State and IPCG testing) [ Time Frame: within 5 years ] [ Designated as safety issue: Yes ] 4. (Serious) adverse events ([S]AEs) [ Time Frame: within 30 days after treatment ] [ Designated as safety issue: Yes ]

—

Countries

Germany

Contacts

Public ContactGerald Illerhaus

Universitätsklinikum Freiburg Innere Medizin - Hämatologie / Onkologie

gerald.illerhaus@uniklinik-freiburg.de+49 761 270-37850

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026