Beschreibung

Rekrutierung gestartet

A Randomized, Open-label, Phase 3 Study of Acalabrutinib in Combination with Rituximab and Reduced Dose CHOP (R-miniCHOP) in Older Adults with Untreated Diffuse Large B-Cell Lymphoma

Studientherapie

Pre-phase treatment (both arms, exceptions apply): prednisolone (or equivalent) 50-100 mg p.o. or i.v. for approx. 7 days.
Immunchemotherapy: six cycles R-miniCHOP [rituximab i.v.: 375 mg/m2 (D0), cyclophosphamide i.v.: 400 mg/m² (D1), doxorubicine i.v.: 25 mg/m² (D1), vincristine i.v.: 1 mg (D1) prednisolone p.o.: 40 mg/m² D1 to D5, repeated every 3 weeks]
Standard arm: six cycles of R-miniCHOP
Experimental arm: six cycles of R-miniCHOP together with acalabrutinib 100mg p.o. twice daily starting from D1 of first R-miniCHOP cycle continuously for a total treatment duration of 12 months.

• ARCHED_Trial synopsis_regarding_protocol_version_V01.4-F_clean