Beschreibung

Rekrutierung beginnt in Kürze

Venetoclax in combination with the BTK inhibitor Ibrutinib and rituximab or conventional chemotherapy (bendamustine) and ibrutinib and rituximab in patients with treatment naïve Mantle Cell Lymphoma not eligible for high dose therapy - The European Mantle Cell Lymphoma Elderly III-Trial

Studientherapie

ARM A (AIR):
Venetoclax:
Cycle 1: day 22-28 20 mg (2 tablets at 10 mg)
Cycle 2: day 1-7 50 mg (1 tablet at 50 mg)
day 8-14 100 mg (1 tablet at 100 mg)
day 15-21 200 mg (2 tablets at 100 mg)
day 22-28 400 mg (4 tablets at 100 mg)
Cycle 3-18: day 1-28 400 mg (4 tablets at 100 mg)
Ibrutinib:
Cycle 1-30: day 1-28 560 mg (4 tablets at 120 mg)
Rituximab:
Cycle 1-6: day 1 375 mg/m2 i.v.

ARM B (BR-I):
Bendamustine
Cycle 1-6: day 1,2 90 mg/m2 i.v.
Rituximab:
Cycle 1-6: day 1 375 mg/m2 i.v.
maintenance day 1 375 mg/m2 i.v. (every 2 months)
Ibrutinib:
Cycle 1-30: day 1-28 560 mg (4 tablets at 120 mg)

• Synopse_ABC trial version 4.1 (002)