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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib for Waldenström Macroglobulinemia

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

Previously treated cohort only: A confirmed diagnosis of WM, which has relapsed after, or been refractory to ≥1prior therapy for WM and which requires treatment

Be older than 18 years old

Must not have

Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or QTc >480 msec

Any immunotherapy within 4 weeks of first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 3.8 years. data cut at last subject have completed cycle 27 (28 days per cycle).

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new drug, acalabrutinib, to see if it is safe and effective in treating people with Waldenström macroglobulinemia.

Who is the study for?

This trial is for adults with Waldenström Macroglobulinemia (WM), a type of blood cancer. It's open to those who haven't been treated before and want an alternative to chemoimmunotherapy, as well as patients whose WM has returned or didn't respond to at least one prior treatment. Participants must be able to swallow capsules and agree to use effective contraception if applicable.

What is being tested?

The study is testing Acalabrutinib (ACP-196) for safety and effectiveness in treating WM. Researchers will look at how the body processes the drug, its impact on the disease, and any potential benefits it may offer.

What are the potential side effects?

While not explicitly listed here, side effects could include typical reactions seen with cancer treatments such as nausea, fatigue, bleeding issues due to blood thinners being prohibited during the trial, possible liver function changes indicated by eligibility criteria related to organ functions.

Eligibility Criteria

Inclusion Criteria

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

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My Waldenstrom macroglobulinemia (WM) has returned or didn't respond to treatment and needs more treatment.

Exclusion Criteria

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

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I do not have serious heart problems like recent heart attacks or severe heart failure.

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I haven't had immunotherapy in the last 4 weeks.

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My white blood cell or platelet counts are very low.

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I have uncontrolled autoimmune blood disorders.

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I have a bleeding disorder like hemophilia.

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I have not had a stroke or brain bleed in the last 6 months.

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I have been treated with specific inhibitors for my condition before.

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I am experiencing side effects from cancer treatment, excluding hair loss.

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I do not have HIV, hepatitis B or C, or any uncontrolled infections.

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I need medication for stomach acid, like omeprazole.

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I have a condition that affects how my stomach or intestines absorb food.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 3.8 years. data cut at last subject have completed cycle 27 (28 days per cycle).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 3.8 years. data cut at last subject have completed cycle 27 (28 days per cycle).

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 3.8 years. data cut at last subject have completed cycle 27 (28 days per cycle). for reporting.