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Bruton's Tyrosine Kinase Inhibitor

Treatment Arm B for High Blood Pressure and Congestive 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

1. Men and women ≥ 18 years of age, at the time of signing the informed consent.

2. Eastern Cooperative Oncology Group performance status of 0 to 3

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

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

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.

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 below

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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

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 more

Secondary 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 more

Side effects data

From 2014 Phase 2 trial • 121 Patients • NCT01441596

90%

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%

Epistaxis

13%

Paronychia

13%

Stomatitis

10%

Hypokalaemia

10%

Muscle spasms

10%

General physical health deterioration

10%

Haemorrhoids

10%

Conjunctivitis

10%

Oedema peripheral

Visual impairment

Fall

Cough

Vision blurred

Abdominal pain upper

Neurotoxicity

Bronchitis

Pruritus

Somnolence

Skin lesion

Dry mouth

Dyspnoea

Urinary tract infection

Anxiety

Rhinorrhoea

Convulsion

Epilepsy

Abdominal distension

Abdominal pain

Gait disturbance

Hypoalbuminaemia

Ataxia

Aspartate aminotransferase increased

Weight decreased

Nail disorder

Balance disorder

Vertigo

Dysuria

Hypocalcaemia

Muscular weakness

Peripheral sensory neuropathy

Malignant neoplasm progression

Myalgia

Lung infection

Dehydration

Dry eye

Rhinitis

Depression

Pyrexia

Pain in extremity

Infection

Pelvic fracture

Renal failure acute

Aphasia

Motor neurone disease

Syncope

Tremor

Lymphopenia

Back pain

Hypercreatinaemia

Metastases to liver

Partial seizures

Anaemia

Pain

Alanine aminotransferase increased

Dysarthria

100%

80%

60%

40%

20%

Study treatment Arm

Afatinib Mono

Investigator's Choice

Afatinib+Vino

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 10Eligibility criteria met