Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia
Status:
Recruiting
Trial end date:
2030-03-01
Target enrollment:
Participant gender:
Summary
This is a multi-centre, open label, single-arm, phase II clinical trial in untreated patients
with Waldenstrom's Macroglobulinemia. Symptomatic, previously untreated patients will receive
SOC bendamustine and rituximab for 6 28-day cycles. Bendamustine will be given intravenously
at 90 mg/m2 on days 1 and 2 of each cycle. Rituximab will be given on day 1 of each cycle
(375 mg/m2 intravenously for the first cycle and 1400 mg subcutaneously OR 375 mg/m2
intravenously for subsequent cycles (as per institutional procedures)). Concomitantly,
participants will receive 100 mg of the investigational product, Acalabrutinib, orally for 1
year (365 days) at 100 mg BID.