Acalabrutinib for Leukemia

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Seema Bhat

Must be taking: Kinase inhibitors

Must not be taking: Steroids, CYP3A4 inhibitors, Anticoagulants, PPIs

Disqualifiers: Cardiovascular disease, Prior malignancy, Others

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

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 24 cycles (approximately 24 months)

61 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial tests how well acalabrutinib works in treating patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and evaluates how treatment with acalabrutinib affects heart function. Acalabrutinib is in a class of medications called kinase inhibitors. It blocks a protein called BTK, which is present on B-cell (a type of white blood cells) cancers at abnormal levels. This may help keep cancer cells from growing and spreading. CLL/SLL patients treated with a different BTK inhibitor called ibrutinib often experience cardiac side effects, leading to discontinuation of life-saving therapy. Treatment with acalabrutinib after discontinuing, or even before starting, treatment with ibrutinib may reverse or prevent cardiac side effects and be an effective treatment option for patients with CLL/SLL.

Research Team

Seema A Bhat, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma. It's designed for those who may have had cardiac side effects from previous treatments like ibrutinib, or are looking to start treatment that could potentially avoid such issues.

Inclusion Criteria

My white blood cell count is healthy or low due to my CLL/SLL condition.

I have been diagnosed with CLL/SLL according to the 2018 iWCLL criteria.

I have CLL and cannot tolerate ibrutinib due to heart rhythm problems.

Exclusion Criteria

I have previously been treated with acalabrutinib for the main study group or a BTK inhibitor for the pilot study.

My cancer has a C481S or PLCG2 mutation.

I have had a stem cell transplant from a donor.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive acalabrutinib orally twice daily on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

24 cycles (approximately 24 months)

Monthly visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up every 6 months for up to 10 years.

Up to 10 years

Biannual visits

Treatment Details

Interventions

• Acalabrutinib

Trial Overview The trial is testing acalabrutinib, a kinase inhibitor targeting the BTK protein on cancerous B-cells. The study will assess its effectiveness in treating CLL/SLL and its impact on heart function compared to previous therapies.

Participant Groups

Group I: Treatment (acalabrutinib) Experimental Treatment 6 Interventions

Patients receive acalabrutinib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CMR, CT, bone marrow aspiration/biopsy, and collection of blood samples throughout the trial.

Who Is Running the Clinical Trial?

Seema Bhat

Lead Sponsor

Trials

2

Recruited

140+

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Acerta Pharma, LLC

Collaborator

Trials

8

Recruited

390+

AstraZeneca

Industry Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology