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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib for Chronic Lymphocytic Leukemia

Phase 2

Waitlist Available

Research Sponsored by Acerta Pharma BV

Eligibility Criteria Checklist

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

Must have

Must have received ≥ 1 prior therapy for CLL

ECOG performance status of ≤ 2

Must not have

Known history of human immunodeficiency virus (HIV), serologic status reflecting active hepatitis B or C infection, or any uncontrolled active systemic infection

Major surgical procedure within 28 days of first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for people with a specific type of leukemia who have stopped responding to treatment with another drug.

Who is the study for?

This trial is for adults with Chronic Lymphocytic Leukemia (CLL) who've had at least one prior treatment and can't tolerate Ibrutinib. They should have progressed after stopping Ibrutinib, be able to swallow capsules, and have a decent performance status. Exclusions include other cancers within 2 years, significant gut surgery or diseases affecting absorption, active infections including HIV/Hepatitis B/C, recent major surgery or heart issues, bleeding disorders, certain drug interactions, previous BCL-2 inhibitor use like Venetoclax.

What is being tested?

The study tests Acalabrutinib's effectiveness and safety in patients with relapsed/refractory CLL intolerant to Ibrutinib therapy. It's a Phase 2 trial focusing on those who didn't respond well to their previous treatments.

What are the potential side effects?

Acalabrutinib may cause side effects such as headaches, diarrhea, muscle pain and bruising easily due to low blood platelets. More serious but less common side effects could include bleeding problems or infections due to low white blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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I have had at least one treatment for chronic lymphocytic leukemia.

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

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My condition worsened after stopping ibrutinib as per specific criteria.

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I have been diagnosed with chronic lymphocytic leukemia (CLL) before.

Exclusion Criteria

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

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I have HIV, hepatitis B or C, or another uncontrolled infection.

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I haven't had major surgery in the last 28 days.

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I am experiencing side effects from ibrutinib treatment.

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I have been treated with a BCL-2 inhibitor before.

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I do not have any major issues with my stomach or intestines that affect how I absorb food or medicine.

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My CLL has spread to my brain or transformed into Richter's syndrome.

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I do not have uncontrolled AIHA or ITP.

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I need treatment with a strong medication that affects liver enzymes.

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I have a history of unusual bleeding.

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My condition worsened on ibrutinib or similar treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years) for reporting.