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Bruton's Tyrosine Kinase Inhibitor
Acalabrutinib for Chronic Lymphocytic Leukemia and Heart Failure
Phase 4
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Treatment naïve or relapsed/refractory patients who received no more than 2 prior lines of systemic anti-CLL treatment
Men and women ≥ 18 years of age, at the time of signing the informed consent
Must not have
Ongoing Richter's transformation
Uncontrolled haemolytic anaemia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Awards & highlights
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
Summary
"This trial will test the safety of acalabrutinib compared to other treatments in patients with CLL and heart problems. Patients with a certain level of heart impairment will be included, and the study
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Acalabrutinib may cause side effects such as headaches, diarrhea, muscle pain, reduced blood cell counts leading to increased infection risk or bleeding problems. Heart-related side effects will be closely monitored due to existing cardiac impairment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had no more than 2 treatments for my CLL.
Select...
I am 18 years old or older.
Select...
My heart's pumping ability is below normal.
Select...
My CLL needs treatment according to the latest guidelines.
Select...
I can care for myself but may not be able to do heavy physical work.
Select...
I have been diagnosed with chronic lymphocytic leukemia (CLL).
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My condition has progressed to Richter's transformation.
Select...
I have uncontrolled anemia causing red blood cells to break down.
Select...
I have been diagnosed with HIV.
Select...
My high blood pressure is not controlled despite treatment.
Select...
I have been treated with a BTK inhibitor before.
Select...
I have been diagnosed with or currently have PML.
Select...
I do not have any active, uncontrolled infections.
Select...
I cannot take pills normally due to issues with my digestive system.
Select...
I have a history of unusual bleeding.
Select...
I do not have any uncontrolled heart or blood vessel problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visits are screening+ 8 visits( every 4 weeks) and then every 16 weeks until termination of the study which would be 4 years from the last subject randomized.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety endpoints 1: To evaluate the incidence of CV (CardioVascular) adverse events leading to drug discontinuation after acalabrutinib treatment compared to investigators choice of treatment.
Safety endpoints 2: To evaluate the duration on treatment prior to drug discontinuation due to CV adverse events after acalabrutinib treatment compared to investigators choice of treatment.
Safety endpoints 3: To evaluate the incidence of life threatening and fatal cardiac events of interest after acalabrutinib treatment compared to investigators choice of treatment.
+4 moreSecondary study objectives
Efficacy Endpoints 1:To evaluate the overall survival after acalabrutinib treatment compared to investigators choice of treatment.
Efficacy Endpoints 2:To evaluate the overall response rate after acalabrutinib treatment compared to investigators choice of treatment.
Efficacy Endpoints 3: To evaluate the duration of response after acalabrutinib treatment compared to investigators choice of treatment.
+2 moreSide effects data
From 2014 Phase 2 trial • 121 Patients • NCT0144159690%
Diarrhoea
38%
Rash
28%
Headache
28%
Asthenia
25%
Nausea
23%
Decreased appetite
20%
Constipation
20%
Fatigue
20%
Mucosal inflammation
20%
Dizziness
20%
Dermatitis acneiform
20%
Dry skin
18%
Vomiting
15%
Palmar-plantar erythrodysaesthesia syndrome
15%
Insomnia
13%
Dyspepsia
13%
Paronychia
13%
Epistaxis
13%
Stomatitis
10%
Muscle spasms
10%
Hypokalaemia
10%
General physical health deterioration
10%
Haemorrhoids
10%
Conjunctivitis
10%
Oedema peripheral
8%
Visual impairment
8%
Bronchitis
8%
Neurotoxicity
8%
Fall
8%
Cough
8%
Vision blurred
8%
Abdominal pain upper
8%
Pruritus
8%
Somnolence
8%
Skin lesion
5%
Urinary tract infection
5%
Dyspnoea
5%
Dry mouth
5%
Anxiety
5%
Rhinorrhoea
5%
Convulsion
5%
Epilepsy
5%
Abdominal distension
5%
Abdominal pain
5%
Gait disturbance
5%
Hypoalbuminaemia
5%
Ataxia
5%
Aspartate aminotransferase increased
5%
Weight decreased
5%
Nail disorder
3%
Lung infection
3%
Dehydration
3%
Dysuria
3%
Peripheral sensory neuropathy
3%
Dry eye
3%
Hypocalcaemia
3%
Balance disorder
3%
Rhinitis
3%
Muscular weakness
3%
Malignant neoplasm progression
3%
Vertigo
3%
Myalgia
3%
Depression
3%
Pyrexia
3%
Pain in extremity
3%
Infection
3%
Pelvic fracture
3%
Renal failure acute
3%
Aphasia
3%
Motor neurone disease
3%
Syncope
3%
Tremor
3%
Lymphopenia
3%
Back pain
3%
Hypercreatinaemia
3%
Metastases to liver
3%
Partial seizures
3%
Anaemia
3%
Pain
3%
Alanine aminotransferase increased
3%
Dysarthria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Afatinib Mono
Investigator's Choice
Afatinib+Vino
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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.
Find a Location
Who is running the clinical trial?
FortreaIndustry Sponsor
18 Previous Clinical Trials
5,363 Total Patients Enrolled
AstraZenecaLead Sponsor
4,402 Previous Clinical Trials
289,123,874 Total Patients Enrolled
eResearch Technology, Inc.Industry Sponsor
4 Previous Clinical Trials
1,312 Total Patients Enrolled
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