Acalabrutinib for Chronic Lymphocytic Leukemia and Heart Failure

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?This will be a global Phase IV, open-label, randomised study to evaluate the safety and tolerability of acalabrutinib (monotherapy, 100 mg orally \[po\], twice daily \[bd\]) compared to investigator's choice of treatment, in patients with CLL (TN or R/R) and moderate to severe cardiac impairment. All patients will have cardiac impairment as defined by LVEF of \< 50%. Randomisation will be stratified by LVEF \> 40% vs ≤ 40% to stratify for moderate and severe cardiac impairment, which for this study are defined as follows: Severe cardiac impairment: in those with LVEF ≤ 40% Moderate cardiac impairment: in those with LVEF \> 40% to \< 50%. The study is planned to take place in approximately 20 centres globally. The study will be conducted in centres that have established close collaboration between the Haematology and Cardiology divisions, preferably with a cardio-oncologist on the team. An IDMC will be responsible for making recommendations for study continuation.

Eligibility Criteria

This trial is for adults with Chronic Lymphocytic Leukemia (CLL) who also have heart failure, specifically those with a left ventricular ejection fraction (LVEF) less than 50%. Patients must be able to take oral medication twice daily and should not have other health conditions that would interfere with the study.

Inclusion Criteria

I have had no more than 2 treatments for my CLL.

I am 18 years old or older.

My heart's pumping ability is below normal.

My CLL needs treatment according to the latest guidelines.

I can care for myself but may not be able to do heavy physical work.

I have been diagnosed with chronic lymphocytic leukemia (CLL).

Exclusion Criteria

My condition has progressed to Richter's transformation.

I have uncontrolled anemia causing red blood cells to break down.

I have been diagnosed with HIV.

My high blood pressure is not controlled despite treatment.

I have been treated with a BTK inhibitor before.

I have been diagnosed with or currently have PML.

I do not have any active, uncontrolled infections.

I cannot take pills normally due to issues with my digestive system.

I have a history of unusual bleeding.

I do not have any uncontrolled heart or blood vessel problems.

Treatment Details

The trial is testing Acalabrutinib, taken orally twice a day, against treatments chosen by the investigator in patients with CLL and moderate to severe heart failure. The safety and tolerability of these treatments are being compared, with special attention to how they affect heart function.

2Treatment groups

Experimental Treatment

Active Control

Group I: Treatment Arm BExperimental Treatment1 Intervention

Patients in Arm B will receive investigator's choice of treatment its duration will be based on standard duration of therapy for that regimen or until disease progression/patient withdrawal/study termination, whichever occurs first.

Group II: Treatment Arm A (Acalabrutinib Monotherapy)Active Control1 Intervention

All participants randomised to Arm A will receive treatment with the investigational product acalabrutinib.

Acalabrutinib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Calquence for: