Acalabrutinib vs Standard Therapy for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

+151 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Acerta Pharma BV

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial compares acalabrutinib with rituximab combined with either idelalisib or bendamustine in patients with chronic lymphocytic leukemia who have already been treated before. Acalabrutinib stops cancer cells from growing, while rituximab helps the immune system kill them. Idelalisib blocks growth signals, and bendamustine damages cancer cell DNA. Acalabrutinib has been approved for the treatment of mantle cell lymphoma and chronic lymphocytic leukemia in the US.

Research Team

Acerta Clinical Trials

Principal Investigator

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

Eligibility Criteria

This trial is for adults with chronic lymphocytic leukemia (CLL) who have had at least one prior treatment. Participants must have a certain level of physical fitness (ECOG 0-2), not be pregnant or breastfeeding, agree to use effective contraception, and meet specific blood disease criteria without severe other health issues like heart disease or uncontrolled infections.

Inclusion Criteria

My condition requires treatment according to specific leukemia criteria.

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

I agree not to donate sperm during the trial.

Exclusion Criteria

I have or am suspected to have Richter's syndrome or prolymphocytic leukemia.

I have not had previous treatments with radio- or toxin-conjugated antibodies.

I am on blood thinners like warfarin.

Treatment Details

Interventions

• Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor)
• Bendamustine (Alkylating Agent)
• Idelalisib (Phosphoinositide 3-Kinase (PI3K) Inhibitor)
• Rituximab (Monoclonal Antibodies)

Trial Overview The study compares the effectiveness of acalabrutinib against two combinations: rituximab with idelalisib or bendamustine in people with previously treated CLL. It aims to determine which treatment works better for managing this type of leukemia.

Participant Groups

Group I: Acalabrutinib (ACP-196) Experimental Treatment 1 Intervention

Acalabrutinib (ACP-196) Monotherapy

Group II: Rituximab Plus Idelalisib or Bendamustine Active Control 3 Interventions

Investigator's Choice of Rituximab Plus Idelalisib or Bendamustine

Who Is Running the Clinical Trial?

Acerta Pharma BV

Lead Sponsor

Trials

46

Recruited

5,900+