Acalabrutinib + Chemotherapy for Waldenstrom's Macroglobulinemia
(BRAWM Trial)

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byNeil L Berinstein, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a combination of two established drugs and one new drug in untreated patients with a specific type of blood cancer. The treatment works by killing cancer cells, boosting the immune system, and blocking growth signals.

Eligibility Criteria

This trial is for adults with untreated Waldenstrom's Macroglobulinemia, a type of lymphoma. Participants must have a life expectancy over 6 months, be willing to use effective birth control methods, and have adequate organ function. They should not have had previous systemic treatments for the disease (except certain allowed therapies) and must be able to comply with study requirements.

Inclusion Criteria

Ability to comply with protocol requirements

I haven't had any drug treatments for my condition, but treatments like plasmapheresis, specific radiation, or corticosteroids for symptoms are okay.

My lymphoma is causing symptoms or is about to cause symptoms.

+10 more

Exclusion Criteria

Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

I have a history of active tuberculosis.

I have had treatment for Waldenstrom macroglobulinemia before.

+22 more

Participant Groups

The trial tests Acalabrutinib in combination with standard-of-care Bendamustine and Rituximab in patients who haven't been treated before. It's an open-label phase II study where participants receive Bendamustine intravenously on two days per cycle, Rituximab either intravenously or subcutaneously once per cycle, and take Acalabrutinib orally twice daily for one year.

1Treatment groups

Experimental Treatment

Group I: Single arm interventionExperimental Treatment3 Interventions

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).

Acalabrutinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Calquence for: