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Compares treatment options for Chronic Lymphocytic Leukaemia
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?
Acalabrutinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for chronic lymphocytic leukaemia.
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
- 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 \ 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%.
- 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
- Left ventricular ejection fraction assessed by ECHO \< 50%.
- Diagnosis of CLL
- Treatment naïve or relapsed/refractory patients who 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. In case of R/R patients with prior history of CNS localisation of...
- 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
- Left ventricular ejection fraction assessed by ECHO \< 50%.
- Diagnosis of CLL
- Treatment naïve or relapsed/refractory patients who received no more than 2 prior lines of systemic anti-CLL treatment.
- Active disease per iwCLL 2018 criteria that requires treatment.
- Meet the following laboratory parameters:
- 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.
- History of prior malignancy except for the following:
- Prior history of malignancy with no evidence of active disease present for more than 3 years before screening or felt to be at low risk for recurrence by treating physician. (b) Adequately treated lentigo maligna...
- Patients with HepB core antibody positive who are surface antigen negative or who are HepC antibody positive will need to have a negative polymerase chain reaction (PCR) result before randomisation and must be willing...
- Patients who are HepB surface antigen positive or HepB PCR positive and those who are HepC PCR positive will be excluded. 14 History of stroke or intracranial haemorrhage within 6 months prior to randomisation. 15...
- Uncontrolled cardiac tachyarrhythmias (sinus, atrial or ventricular) that require new/additional therapy within the last month.
- Clinically significant outlying QT interval corrected by Fridericia's formula (QTcF) values; QTcF \> 470 ms or QTcF \< 330 ms.
- Unstable ischaemic heart disease (IHD), recent (\< 3 months): episode of acute coronary syndrome, including acute myocardial infarction and unstable angina pectoris.
- Percutaneous coronary intervention, or coronary artery bypass graft within the last month. 21 Uncontrolled hypertension despite optimal management. 22 Current life-threatening illness, medical conditions, organ system...
The study team makes the final eligibility decision.
Where it's taking place
- Charlotte, North Carolina, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Brno, Czechia
- Hradec Králové, Czechia
- Prague, Czechia
- Cagliari, Italy
- Florence, Italy
- Milan, Italy
- Pavia, Italy
- Perugia, Italy
- Krakow, Poland
- Poznan, Poland
- Barcelona, Spain
- Madrid, Spain
- Seville, Spain
- Bournemouth, United Kingdom
- Oxford, United Kingdom
- Plymouth, United Kingdom
- Romford, United Kingdom
+ 2 more site(s).
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 - 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?
Study sites include Charlotte, North Carolina, United States; Columbus, Ohio, United States; Philadelphia, Pennsylvania, United States; Brno, Czechia; Hradec Králové, Czechia; Prague, Czechia and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.