Chronic Lymphocytic Leukaemia study: Acalabrutinib
Official title Acalabrutinib Monotherapy vs Investigator's Choice of Treatment in Patients With CL Leukaemia and Heart Failure
ClinicalTrials.gov ID: NCT06651970
What this study is testing
What is Acalabrutinib?
An investigational oral medication being studied for chronic lymphocytic leukaemia in patients with moderate to severe cardiac impairment. It is designed to inhibit Bruton's tyrosine kinase, a protein involved in B‑cell receptor signaling.
Also referred to as Calquence.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see how safe and well-tolerated acalabrutinib is compared with other treatments in these patients.
- Who it's for
- Adults with chronic lymphocytic leukaemia (new or relapsed/refractory) who also have moderate to severe heart impairment.
- What's involved
- Participants will take 100 mg of acalabrutinib by mouth twice a day or receive a treatment chosen by their doctor. They will have regular clinic visits and medical tests to monitor safety.
- Phase 4: studies an already-approved treatment
- Time commitment: about 6 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 130
You may be able to join if
- Men and women ≥ 18 years of age, at the time of signing the informed consent.
- Eastern Cooperative Oncology Group performance status of 0 to 3
- Meet at least one of the following cardiovascular - Left ventricular ejection fraction (LVEF) \< 50% as assessed by local ECHO at screening.
- Diagnosis of CLL
- Treatment naïve or relapsed/refractory patients who have received no more than 2 prior lines of systemic anti-CLL treatment.
You likely can't join if
- Known active CNS leukaemia, leptomeningeal disease or spinal cord compression.
- Ongoing Richter's transformation.
- Prior exposure to a BTKi.
- Major surgery within 30 days before first dose of study treatment.
- Uncontrolled haemolytic anaemia.
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study treatment.
See the full eligibility criteria
- Men and women ≥ 18 years of age, at the time of signing the informed consent.
- Eastern Cooperative Oncology Group performance status of 0 to 3
- Meet at least one of the following cardiovascular - Left ventricular ejection fraction (LVEF) \< 50% as assessed by local ECHO at screening.
- Diagnosis of CLL
- Treatment naïve or relapsed/refractory patients who have received no more than 2 prior lines of systemic anti-CLL treatment.
- Active disease per iwCLL 2018 criteria that requires treatment.
- Absolute neutrophil count (ANC) ≥ 500 cells/μL (0.50 × 109/L).
- Platelet count ≥ 30,000 cells/μL (30 × 109/L).
- Serum aspartate aminotransferase and ALT ≤ 3.0 × ULN.
- Total bilirubin ≤ 1.5 × ULN unless directly attributable to Gilbert's syndrome.
- Estimated creatinine clearance (ie, estimated glomerular filtration rate [eGFR] using Cockcroft-Gault) ≥ 40 mL/min, or serum creatinine ≤ 2 × ULN.
- Women and men who are sexually active and can bear children must agree to use highly effective forms of contraception while on the study and for 2 days after the last dose of acalabrutinib.
- Patients must be willing and able to adhere to the study visit schedule, understand, and comply with other protocol requirements, and provide written informed consent and authorisation to use protected health...
- Known active CNS leukaemia, leptomeningeal disease or spinal cord compression. In case of R/R patients with prior history of CNS localisation of leukaemia who received treatment are eligible provided that there is no...
- Ongoing Richter's transformation.
- Prior exposure to a BTKi.
- Major surgery within 30 days before first dose of study treatment.
- Uncontrolled haemolytic anaemia.
- Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study treatment.
- Received a live virus vaccination within 28 days of first dose of study treatment.
- History of or ongoing confirmed PML.
- Baseline cardiac troponin (cTnI or cTnT or hs-cTn) levels greater than the upper limit of normal (per the local laboratories reference range) that is due to an acute coronary event and cannot be fully explained by...
- Uncontrolled cardiac tachyarrhythmias (sinus, atrial or ventricular) that require new/additional therapy within the last month.
- Clinically significant QT prolongation defined as QT interval corrected by Fridericia's formula (QTcF) values; QTcF \> 500 ms.
- Any of the following within the last 3 months: i. Unstable IHD: percutaneous coronary intervention, coronary artery bypass surgery, or an episode of acute coronary syndrome including acute myocardial infarction and...
The study team makes the final eligibility decision.
Where it is enrolling
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Brno, Czechia
- Prague, Czechia
- Cagliari, Italy
- Florence, Italy
- Milan, Italy
- Pavia, Italy
- Perugia, Italy
- Krakow, Poland
- Poznan, Poland
- Barcelona, Spain
- Madrid, Spain
- Seville, Spain
- Oxford, United Kingdom
- Plymouth, United Kingdom
- Sutton Coldfield, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States; Brno, Czechia; Prague, Czechia; Cagliari, Italy; Florence, Italy and 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.