NCT05583071

Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL

Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in Patients Ineligible for HCT-ASCT With Primary Central Nervous System Lymphoma (PCNSL)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in patients ineligible for HCT-ASCT with Primary Central Nervous System Lymphoma (PCNSL)

Detailed description

This is a single-arm, prospective, multicenter, single-stage phase-II trial for patients aged 18-69 years with ECOG PS ≥2 or ≥70 years with previously untreated PCNSL, who are not eligible for HCT-ASCT at investigators decision. This trial evaluates the CRR rate after at least 2 cycles of MTR2, the incidence and severity of adverse events, progression-free survival, and overall survival after one year. It is planned to enroll eligible patients with PCNSL, i.e. who receive at least 2 cycles of the combination of rituximab, MTX and the IMPs tafasitamab and lenalidomide, over a one-year period. Follow-up will be conducted for 1 year within the trial.

Conditions

• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Tafasitamab	IV
DRUG	Lenalidomide	Oral
DRUG	Rituximab	IV
DRUG	Methotrexate	IV

Timeline

• Start date: 2024-08-23
• Primary completion: 2027-02-01
• Completion: 2027-04-01
• First posted: 2022-10-17
• Last updated: 2025-08-13

Locations

6 sites across 1 country: Germany