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BTK Inhibitor

Acalabrutinib for Chronic Lymphocytic Leukemia (ASSURE Trial)

Phase 3

Waitlist Available

Led By Dr. Carsten Niemann, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Monoclonal B-cells (either kappa or lambda light chain restricted) that are clonally co-expressing ≥1 B-cell marker (CD19, CD20, and CD23) and CD5 during screening

Evidence of progressive marrow failure as manifested by the development of, or worsening of, anemia (hemoglobin <10 g/dL) and/or thrombocytopenia (platelets <100,000/μL).

Must not have

Estimated creatinine clearance of <30 mL/min, calculated using the formula of Cockcroft and Gault or by direct assessment (i.e., creatinine clearance or ethylene diamine tetra-acetic acid (EDTA) clearance measurement)

Central nervous system (CNS) involvement by CLL.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year after initial dose of study drug

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a new medication, acalabrutinib, to see if it is safe and effective in treating people with chronic lymphocytic leukemia. The trial will last for approximately 72 months and will enroll 600 participants.

Who is the study for?

This trial is for adults with chronic lymphocytic leukemia (CLL) who are either untreated, have relapsed or are refractory to previous treatments, or have had prior ibrutinib therapy. Participants must show signs of progressive disease and meet specific blood cell count criteria. Pregnant women, individuals with recent malignancies other than CLL, those on certain medications like proton-pump inhibitors or strong CYP3A inhibitors/inducers, and patients with significant heart issues cannot join.

What is being tested?

The study tests the safety and effectiveness of acalabrutinib taken twice daily in three groups: treatment-naive patients, those whose CLL has returned or didn't respond to past treatments, and patients previously treated with ibrutinib. The trial will last about six years including a two-year recruitment phase followed by up to four years of treatment cycles.

What are the potential side effects?

Potential side effects from acalabrutinib may include headache, diarrhea, muscle pain, feverish symptoms similar to colds or flu-like conditions. There could also be more serious risks such as bleeding problems due to low platelet counts or high blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My blood test shows a specific type of abnormal B-cells.

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My blood tests show worsening anemia or low platelets.

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I have very large (over 10 cm), growing, or bothersome swollen lymph nodes.

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My spleen is very large, getting bigger, or causing symptoms.

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My cancer has been tested for specific genetic changes recently.

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My autoimmune blood condition doesn't improve with standard treatments.

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I have been diagnosed with CLL according to the 2018 Hallek criteria.

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I can take care of myself but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function, measured by creatinine clearance, is below 30 mL/min.

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My chronic lymphocytic leukemia has spread to my brain.

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I have a history of or currently have interstitial lung disease.

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I have a bleeding disorder like hemophilia.

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I have been diagnosed with progressive multifocal leukoencephalopathy.

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I have a blood condition that is not under control and requires high doses of steroids.

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I have not had major surgery in the last 4 weeks or have fully recovered from it.

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My condition worsened while I was on a BTK inhibitor treatment.

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I do not have significant GI issues affecting food absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year after initial dose of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year after initial dose of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after initial dose of study drug for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with adverse events

Secondary study objectives

Duration of response (DOR)

Overall response (OR)

Progression-free survival (PFS)

Other study objectives

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30)

Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE)

Plasma concentrations of acalabrutinib and ACP 5862

Side effects data

From 2020 Phase 2 trial • 177 Patients • NCT04346199

Headache

Septic shock

Ischaemic stroke

Chronic obstructive pulmonary disease

100%

80%

60%

40%

20%

Study treatment Arm

BSC Alone

Acalabrutinib + BSC

Awards & Highlights

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

1Treatment groups

Experimental Treatment

Group I: AcalabrutinibExperimental Treatment1 Intervention

Participants will be enrolled into 3 cohorts. In the treatment-naive cohort, a minimum of 300 participants with treatment-naïve chronic lymphocytic leukemia will be enrolled. In the relapsed/refractory cohort, approximately 200 participants with relapsed/refractory chronic lymphocytic leukemia will be enrolled. In the prior ibrutinib cohort, approximately 40 participants with Prior ibrutinib therapy will be enrolled.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2080

0 / 17Eligibility criteria met