Bendamustine, Rituximab and Acalabrutinib in Waldenstrom's Macroglobulinemia

Sponsor
Sunnybrook Health Sciences Centre
Study ID
NCT04624906
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Waldenstrom Macroglobulinemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    100 mg oral capsules twice daily for 1 year
  • Bendamustine — DRUG
    90 mg/m2 on days 1 and 2 of each cycle.
  • Rituximab — DRUG
    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).

Study Details

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.

Key Dates

Start date
Mar 2, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2025
Completion
Mar 31, 2030

Study Design

Enrollment
63 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm intervention
    100 mg Acalabrutinib (ACP-196) oral capsules twice daily for 1 year Bendamustine and rituximab will be given for 6 x 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).

Primary Outcome Measure

Best combined complete response (CR) and very good partial response (VGPR) [ Time Frame: through study completion, an average of 1 year - cycle 7, 12 (day 1 of 28 day cycle) up to 18 months ]

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