MTR² - GLA 2022-7
MTR² (Methotrexate, tafasitamab, lenalidomide, rituximab)
Rekrutierung gestartet/nimmt Patienten auf
Herr Dr. med. Jan-Michel Heger
jan-michel.heger@uk-koeln.de
Universitätsklinikum Köln - IM I (Prüfzentrum (CAR-T), 12456)
Klinik I für Innere Medizin
Kerpener Str. 62
50937 Köln
Previously untreated primary B-cell lymphoma of the central nervous system (PCNSL) in patients aged 18-70 years with ECOG PS e2 or >70 years who are ineligible for HCT-ASCT as per investigators discretion.
20
Complete response rate (CRR) after at least 2 cycles of MTR² as determined by independent review committee (IRC) and according to International Primary CNS Lymphoma Collaborative Group (IPCG) criteria
• Safety as determined by incidence and severity of adverse events
• Feasibility as determined by proportion of patients completing 4 cycles of MTR2 and relative dose intensity of planned and administered cycles
• Efficacy as determined by:
o Best overall response rate (BORR) after 4 cycles of MTR²
o Progression-free survival (PFS) rate at 1 year
o Overall survival (OS) rate at 1 year
• Quality of life and neurocognitive impairment over time as determined by EORTC QLQ-C30 and BN20 questionnaires as well as Montreal Cognitive Assessment (MoCA), respectively
24 Monate
6
Incyte
Ja
