Acalabrutinib for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+21 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?A Phase 2 Study to evaluate the Efficacy and Safety of ACP-196 (acalabrutinib) in Subjects with Relapsed/Refractory CLL and Intolerant of Ibrutinib Therapy

Eligibility Criteria

This trial is for adults with Chronic Lymphocytic Leukemia (CLL) who've had at least one prior treatment and can't tolerate Ibrutinib. They should have progressed after stopping Ibrutinib, be able to swallow capsules, and have a decent performance status. Exclusions include other cancers within 2 years, significant gut surgery or diseases affecting absorption, active infections including HIV/Hepatitis B/C, recent major surgery or heart issues, bleeding disorders, certain drug interactions, previous BCL-2 inhibitor use like Venetoclax.

Inclusion Criteria

I have had at least one treatment for chronic lymphocytic leukemia.

Intolerant of ibrutinib

Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty

+4 more

Exclusion Criteria

I have HIV, hepatitis B or C, or another uncontrolled infection.

I have not had a stroke or brain bleed in the last 2 months.

Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3 months before screening

+12 more

Participant Groups

The study tests Acalabrutinib's effectiveness and safety in patients with relapsed/refractory CLL intolerant to Ibrutinib therapy. It's a Phase 2 trial focusing on those who didn't respond well to their previous treatments.

1Treatment groups

Experimental Treatment

Group I: ACP-196 (acalabrutinib)Experimental Treatment1 Intervention

ACP-196 (acalabrutinib) 100 mg to be administered orally (PO) twice a day BID