Actively Recruiting
Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
Led by AstraZeneca · Updated on 2026-04-15
60
Participants Needed
23
Research Sites
288 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older at consent
- Eastern Cooperative Oncology Group performance status of 0 to 3
- Left ventricular ejection fraction less than 50% measured by ECHO
- Diagnosis of chronic lymphocytic leukemia (CLL)
- Treatment naive or relapsed/refractory with no more than 2 prior systemic anti-CLL treatments
- Active disease requiring treatment according to iwCLL 2018 criteria
- Laboratory requirements: ANC ≥ 500 cells/µL, platelet count ≥ 30,000 cells/µL, AST and ALT ≤ 3 times upper limit of normal, total bilirubin ≤ 1.5 times upper limit of normal (unless Gilbert's syndrome), eGFR ≥ 40 mL/min or serum creatinine ≤ 2 times upper limit of normal
- Agreement to use highly effective contraception if sexually active and able to bear children during and for 2 days after last dose
- Willingness and ability to follow study visits, protocol requirements, and provide informed consent
You will not qualify if you...
- Active central nervous system leukemia, leptomeningeal disease, or spinal cord compression unless treated and no evidence of CNS involvement at entry
- Ongoing Richter's transformation
- Prior exposure to a BTK inhibitor
- Major surgery within 30 days before first dose
- Uncontrolled hemolytic anemia
- Use of investigational drugs within 30 days or 5 half-lives before first dose
- Live virus vaccination within 28 days before first dose
- History or ongoing progressive multifocal leukoencephalopathy (PML)
- History of prior malignancy unless disease-free for over 3 years or low risk of recurrence, or certain treated skin or cervical/prostate cancers without current disease
- Inability to swallow tablets or significant gastrointestinal conditions
- Active uncontrolled systemic or localized infection
- Known HIV infection
- Active Hepatitis B or C infection or positive PCR testing for these infections
- Stroke or intracranial hemorrhage within 6 months prior to randomization
- History of bleeding disorders like hemophilia or von Willebrand disease
- Use of warfarin or equivalent anticoagulants within 7 days before first dose; stable use of DOACs or LMWH allowed
- Use of strong CYP3A inhibitors or inducers near first dose
- Pregnant or breastfeeding
- Participation in another therapeutic clinical trial
- Uncontrolled cardiac conditions including unstable arrhythmias, significant QT interval abnormalities, recent unstable ischemic heart disease, recent coronary interventions
- Uncontrolled hypertension despite treatment
- Any life-threatening illness or condition compromising safety or study adherence as judged by investigator
AI-Screening
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Trial Site Locations
Total: 23 locations
1
Research Site
Charlotte, North Carolina, United States, 28204
Withdrawn
2
Research Site
Columbus, Ohio, United States, 43210
Actively Recruiting
3
Research Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
4
Research Site
Brno, Czechia, 625 00
Actively Recruiting
5
Research Site
Hradec Králové, Czechia, 500 05
Withdrawn
6
Research Site
Prague, Czechia, 10034
Actively Recruiting
7
Research Site
Cagliari, Italy, 09121
Actively Recruiting
8
Research Site
Florence, Italy, 50134
Actively Recruiting
9
Research Site
Milan, Italy, 20122
Actively Recruiting
10
Research Site
Milan, Italy, 20132
Actively Recruiting
11
Research Site
Pavia, Italy, 27100
Actively Recruiting
12
Research Site
Perugia, Italy, 06156
Actively Recruiting
13
Research Site
Krakow, Poland, 30-727
Actively Recruiting
14
Research Site
Poznan, Poland, 60-693
Actively Recruiting
15
Research Site
Barcelona, Spain, 08003
Actively Recruiting
16
Research Site
Madrid, Spain, 28040
Actively Recruiting
17
Research Site
Seville, Spain, 41009
Actively Recruiting
18
Research Site
Bournemouth, United Kingdom, BH7 7DW
Not Yet Recruiting
19
Research Site
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
20
Research Site
Plymouth, United Kingdom, PL6 8DH
Actively Recruiting
21
Research Site
Romford, United Kingdom, RM7 0AG
Actively Recruiting
22
Research Site
Stockton, United Kingdom, TS19 8PE
Withdrawn
23
Research Site
Sutton Coldfield, United Kingdom, B74 3UP
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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