NCT04931368

OptiMATe: De-escalated Induction Treatment in Primary CNS Lymphoma

Optimizing MATRix as Remission Induction in PCNSL: De-escalated Induction Treatment in Newly Diagnosed Primary CNS Lymphoma - a Randomized Phase III Trial

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 331 (actual)
• Sponsor: Klinikum Stuttgart · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This phase III study investigates if a de-escalated induction treatment in newly diagnosed primary CNS lymphoma is superior to the standard MATRix protocol in terms of event free survival.

Detailed description

This phase III study investigates if a de-escalated induction treatment in newly diagnosed primary CNS lymphoma is superior to the standard MATRix protocol in terms of event free survival. Two arms are compared, in the experimental treatment group, participants receive one course of R/HD-MTX, followed by two courses of MATRix and autologous stem cell transplantation. In the control treatment, participants receive four coourses of MATRix followed by autologous stem cell transplantation.

Conditions

• Primary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	Experimental Treatment: one course Rituximab/HD-Methotrexate, two courses of MATRix	De-escalated induction treatment with R/HD-MTX and two courses of MATRix
DRUG	Control intervention: four courses of MATRix	Patients receive four courses of MATRix as induction treatment.

Timeline

• Start date: 2021-06-28
• Primary completion: 2028-06-01
• Completion: 2028-11-01
• First posted: 2021-06-18
• Last updated: 2026-03-18

Locations

1 site across 1 country: Germany