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Compensation: Varies

Number of Visits: 1

Duration: 55.2 months

533 Participants Needed

Acalabrutinib vs Ibrutinib for Chronic Lymphocytic Leukemia

Recruiting at 122 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Acerta Pharma BV

Must not be taking: Warfarin, Strong CYP3A inhibitors

Disqualifiers: CNS lymphoma, Richter's syndrome, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot take certain drugs like strong CYP3A inhibitors/inducers or anticoagulants like warfarin within 7 days of starting the study drug.

What is the safety profile of Acalabrutinib and Ibrutinib for treating chronic lymphocytic leukemia?

Ibrutinib (Imbruvica) is generally well-tolerated but can cause side effects like bleeding and atrial fibrillation (irregular heartbeat). Acalabrutinib may lead to cardiac issues, such as an increased risk of heart-related events, but does not significantly increase the risk of high blood pressure or severe heart problems. Both drugs have been approved for use and are considered to have an acceptable safety profile.¹ ² ³ ⁴ ⁵

How does the drug acalabrutinib differ from ibrutinib for treating chronic lymphocytic leukemia?

Acalabrutinib is a newer drug that is more selective in targeting the Bruton tyrosine kinase, which may lead to fewer side effects compared to ibrutinib. Both drugs have similar effectiveness in delaying disease progression, but acalabrutinib is generally better tolerated by patients.³ ⁶ ⁷ ⁸ ⁹

What is the purpose of this trial?

This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.

Research Team

Acerta Clinical Trials

Principal Investigator

1-888-292-9613

Eligibility Criteria

This trial is for adults over 18 with chronic lymphocytic leukemia (CLL) who have high-risk factors like certain genetic deletions or active disease requiring treatment. They must have had at least one prior CLL therapy, meet specific blood cell count criteria, and not be dependent on blood transfusions. People with a history of CNS leukemia, recent major surgery, or exposure to similar drugs are excluded.

Inclusion Criteria

Meet the following laboratory parameters: Absolute neutrophil count (ANC) ≥ 750 cells/μL or ≥ 500 cells/μL in participants with documented bone marrow involvement, and independent of growth factor support 7 days before assessment, Platelet count ≥ 30,000 cells/μL without transfusion support 7 days before assessment. Participants with transfusion-dependent thrombocytopenia are excluded, Serum aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3.0 x upper limit of normal (ULN), Total bilirubin ≤ 1.5 x ULN, Estimated creatinine clearance ≥ 30 mL/min

I have high-risk CLL with specific genetic changes or need treatment based on certain criteria.

I can care for myself and am up and about more than 50% of my waking hours.

See 1 more

Exclusion Criteria

I need treatment with a strong medication that affects liver enzymes.

I have been diagnosed with CNS lymphoma or leukemia.

I have uncontrolled autoimmune blood disorders.

See 12 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (in-person)

Treatment

Participants receive either acalabrutinib or ibrutinib until disease progression or unacceptable toxicity

55.2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

28.3 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

Treatment Details

Interventions

ACP-196
Ibrutinib

Trial Overview The study compares the effectiveness of two drugs in treating CLL: Acalabrutinib and Ibrutinib. It focuses on which drug better prevents the disease from getting worse in patients who've already been treated before.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: AcalabrutinibExperimental Treatment1 Intervention

Participants will receive oral acalabrutinib 100 mg twice daily (BID) until disease progression (PD), or unacceptable toxicity, or other reasons for discontinuation, whichever occurs first.

Group II: IbrutinibActive Control1 Intervention

Participants will receive oral ibrutinib 420 mg once daily (QD) until PD, or unacceptable toxicity, or other reasons for discontinuation, whichever occurrs first.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Acerta Pharma BV

Lead Sponsor

Trials

Recruited

5,900+

Findings from Research

Acalabrutinib, a selective Bruton's tyrosine kinase inhibitor, was found to increase the risk of any-grade cardiac events in patients with chronic lymphocytic leukemia, with a risk ratio of 1.75.

There was a notable trend indicating a higher risk of any-grade atrial fibrillation associated with acalabrutinib, with a risk ratio of 2.56, although no significant increase in hypertension or high-grade cardiac events was observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acalabrutinib-Related Cardiac Toxicities in Patients with Chronic Lymphocytic Leukemia: A Meta-Analysis of Randomized Controlled Trials.Htut, TW., Han, MM., Thein, KZ.[2022]

Ibrutinib is a targeted therapy specifically designed for treating chronic lymphocytic leukemia (CLL), which is a type of cancer that affects the blood and bone marrow.

This novel treatment works by inhibiting Bruton's tyrosine kinase (BTK), a key enzyme that helps cancer cells survive and proliferate, leading to improved patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ibrutinib (imbruvica): a novel targeted therapy for chronic lymphocytic leukemia.Parmar, S., Patel, K., Pinilla-Ibarz, J.[2021]

Acalabrutinib has been approved in the EU for treating both treatment-naïve and relapsed/refractory chronic lymphocytic leukemia (CLL), showing significant improvements in progression-free survival compared to standard therapies in two phase III trials involving adult patients.

The safety profile of acalabrutinib is generally acceptable, with common side effects including headache, diarrhea, and infections, and the overall benefit-risk ratio is considered positive for its use in CLL.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMA Review of Acalabrutinib for the Treatment of Adult Patients with Chronic Lymphocytic Leukemia.Delgado, J., Josephson, F., Camarero, J., et al.[2021]