Acalabrutinib for Waldenström Macroglobulinemia

Recruiting in Palo Alto (17 mi)

+37 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Acerta Pharma BV

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and activity of acalabrutinib in treating subjects with WM.

Eligibility Criteria

This trial is for adults with Waldenström Macroglobulinemia (WM), a type of blood cancer. It's open to those who haven't been treated before and want an alternative to chemoimmunotherapy, as well as patients whose WM has returned or didn't respond to at least one prior treatment. Participants must be able to swallow capsules and agree to use effective contraception if applicable.

Inclusion Criteria

I can swallow capsules without difficulty and can participate in all study procedures.

Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)

I agree to use effective birth control during and 2 days after the study.

+2 more

Exclusion Criteria

I do not have serious heart problems like recent heart attacks or severe heart failure.

I haven't had immunotherapy in the last 4 weeks.

I had cancer before, but it was either skin cancer treated successfully, cervical cancer that did not spread, or another type from which I've been free for 2+ years.

+17 more

Participant Groups

The study is testing Acalabrutinib (ACP-196) for safety and effectiveness in treating WM. Researchers will look at how the body processes the drug, its impact on the disease, and any potential benefits it may offer.

2Treatment groups

Experimental Treatment

Group I: Treatment NaïveExperimental Treatment1 Intervention

Subjects with treatment-naïve Waldenström Macroglobulinemia. N=14

Group II: Previously TreatedExperimental Treatment1 Intervention

Subjects previously treated with Waldenström Macroglobulinemia N=92