A Multi-Center, Open-Label, Single-Arm Phase II Trial of Bendamustine, Rituximab and the Second Generation BTK Inhibitor Acalabrutinib in Previously Untreated Waldenstrom's Macroglobulinemia (BRAWM)

NCT04624906 Phase 2 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Sunnybrook Health Sciences Centre
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	63
Start date	2021-03-02
Completion	2030-03

Conditions

• Waldenstrom Macroglobulinemia

Interventions

• Acalabrutinib
• Bendamustine
• Rituximab

Primary outcomes

• Best combined complete response (CR) and very good partial response (VGPR) — through study completion, an average of 1 year - cycle 7, 12 (day 1 of 28 day cycle) up to 18 months
  To document the best combined CR and VGPR rate of first-line treatment with bendamustine and rituximab plus acalabrutinib in patients with WM using response criteria from the Sixth International Workshop on Waldenstrom's Macroglobulinemia9. Response will be documented at cycle 7, 12 and 18 (durable CR).

Countries

Canada