Acalabrutinib + ACP-319 for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Acerta Pharma BV

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This study is evaluating the safety and efficacy of the combined use of acalabrutinib and ACP-319, for the treatment of chronic lymphocytic leukemia (CLL)

Research Team

Acerta Clinical Trials

Principal Investigator

1-888-292-9613 [e-mail]

Eligibility Criteria

Adults over 18 with chronic lymphocytic leukemia (CLL) that has come back or didn't respond to at least one treatment can join this trial. Those with certain genetic changes in their CLL may qualify after just one prior treatment. Participants must be able to perform daily activities with relative ease, agree to use birth control, and not have other serious health issues or recent treatments that could affect the study.

Inclusion Criteria

I am over 18 and my CLL has not improved after at least one treatment, or it came back.

I can take care of myself and am up and about more than half of my waking hours.

Agreement to use contraception during the study and for 30 days after the last dose of study drugs if sexually active and able to bear or beget children.

Exclusion Criteria

History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.

I do not have a severe illness that could risk my safety in the study.

I will start the study drug after waiting 5 half-lives since my last chemotherapy or experimental therapy.

Treatment Details

Interventions

• Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
• ACP-319 (Other)

Trial Overview The trial is testing a combination of two drugs, acalabrutinib and ACP-319, for treating CLL. It aims to find out how safe this combo is and how well it works against the disease.

Participant Groups

Group I: acalabrutinib Experimental Treatment 2 Interventions

Starts with acalabrutinib for 7 days, then combined with ACP-319 afterwards.

Group II: ACP-319 Experimental Treatment 2 Interventions

Starts with ACP-319 for 7 days, then combined with acalabrutinib afterwards.

Who Is Running the Clinical Trial?

Acerta Pharma BV

Lead Sponsor

Trials

46

Recruited

5,900+