Acalabrutinib for Mantle Cell Lymphoma

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

Pathologically confirmed MCL, with documentation of monoclonal B cells that have a chromosome translocation t(11;14)(q13;q32) and/or overexpress cyclin D1

Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

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 corrected QT interval (QTc) > 480 msec

Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers learn more about how safe and effective ACP-196 is for treating people with a certain type of cancer that has come back or does not respond to other treatments.

Who is the study for?

This trial is for adults over 18 with confirmed Mantle Cell Lymphoma (MCL) who have relapsed or are not responding to treatment. Participants must be relatively fit (ECOG ≤ 2), able to use contraception, and not have severe illnesses that could risk their safety or affect the study drug's absorption.

What is being tested?

The trial is testing ACP-196 (acalabrutinib) for its effectiveness and safety in patients with MCL that has come back or isn't getting better. It's an open-label, Phase 2 study which means everyone knows they're receiving acalabrutinib and it’s fairly early in the clinical trials process.

What are the potential side effects?

While specific side effects of ACP-196 aren't listed here, similar medications can cause headaches, diarrhea, muscle aches, reduced blood cell counts increasing infection risk, bruising or bleeding easily, irregular heartbeat among others.

Eligibility Criteria

Inclusion Criteria

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

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My Mantle Cell Lymphoma (MCL) has specific genetic markers.

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

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I do not have significant issues with my digestive system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of the first dose until 30 days after the last dose of the study drug or start of a new anti-cancer treatment, whichever came first, assessed up to approximately 4 year and 10 months. 1 cycle =28 days for reporting.