Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia (NCT04624906)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Tom Baker Cancer Centre — Calgary, Alberta
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- Tom Baker Cancer Centre — Calgary, Alberta
- Cross Cancer Institute — Edmonton, Alberta
- Vancouver General Hospital — Vancouver, British Columbia
- QEII Health Sciences Centre — Halifax, Nova Scotia
- Hamilton Health Sciences Centre - Juravinksi — Hamilton, Ontario
- The Ottawa Hospital — Ottawa, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario
- CHU de Quebec - University Laval — Laval, Quebec
- McGill University Health Centre — Montreal, Quebec
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Waldenstrom Macroglobulinemia
- Study of Iopofosine I-131 (CLR 131) in Select B-Cell Malignancies (CLOVER-1) With Expansion in Waldenstrom — Los Angeles, California
- Pirtobrutinib and Venetoclax in Waldenström Macroglobulinemia — Boston, Massachusetts
- Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer — Bethesda, Maryland
- A Study to Investigate Efficacy and Safety of BCL2 Inhibitor Sonrotoclax as Monotherapy and in Combination With Zanubrutinib in Adults With Waldenström Macroglobulinemia — Duarte, California
- Ibrutinib + Venetoclax in Untreated WM — Boston, Massachusetts
Explore by condition: All Waldenstrom Macroglobulinemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.