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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib for Mantle Cell Lymphoma

Phase 2

Recruiting

Led By Preetesh Jain

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

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

Must have

- 1 or more grade 3 neutropenia with infection or fever; OR,

Creatinine (Cr) clearance minimum to 30 mL/min per the Cockcroft-Gault formula as acalabrutinib pharmacokinetic (PK) has not been evaluated in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 29 mL/min/1.7 3^m2, MDRD) or renal impairment requiring dialysis

Must not have

Any of the following cardiac related conditions:

- Uncontrolled hypertension,

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

Summary

This trial studies the effects of acalabrutinib on patients with mantle cell lymphoma who cannot tolerate ibrutinib.

Who is the study for?

This trial is for patients with mantle cell lymphoma who had adverse reactions to ibrutinib. They must have resolved toxicities, acceptable blood counts, organ function within certain limits, no history of certain BTK mutations or progressive disease on ibrutinib, and not be pregnant or breastfeeding. Eligible participants should also agree to use effective contraception.

What is being tested?

The study tests acalabrutinib's effectiveness in treating mantle cell lymphoma in patients intolerant to ibrutinib. It examines whether acalabrutinib can halt cancer growth by inhibiting enzymes necessary for the proliferation of cancer cells.

What are the potential side effects?

Potential side effects include bleeding risks, heart rhythm problems, infections due to immune system suppression, liver enzyme changes indicating potential liver damage, and other common chemotherapy-related side effects like fatigue and digestive issues.

Eligibility Criteria

Inclusion Criteria

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

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I have had severe low white blood cell counts with fever or infection.

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My kidneys work well enough (Cr clearance over 30 mL/min).

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My lymphoma is CD20 positive with specific genetic features.

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I have experienced severe side effects from treatment.

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My treatment was stopped due to severe blood-related side effects, not cancer progression.

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I can do most of my daily activities on my own.

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I stopped taking ibrutinib for reasons other than my cancer getting worse.

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I have two or more serious side effects not related to my blood.

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My treatment was stopped due to severe blood-related side effects, not because my condition worsened.

Exclusion Criteria

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

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I have a heart condition.

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My blood pressure is not well-controlled.

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I do not have any major stomach or bowel problems that could affect medication absorption.

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I have not had major surgery in the last 4 weeks.

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I am taking more than 10 mg of prednisone or its equivalent daily.

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I have not had a heart attack in the last 6 months.

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My heart condition severely limits my daily activities.

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My heart rate is often below 50 beats per minute.

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I haven't had any recent bleeding disorders or strokes.

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I have not progressed or had an allergic reaction while on ibrutinib therapy.

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I have uncontrolled AIHA or ITP.

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I haven't taken antibiotics or antivirals in the last 14 days.

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I have active heart disease symptoms.

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I have been treated with acalabrutinib before.

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I need medication that strongly affects liver enzymes.

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I have been diagnosed with sick sinus syndrome.

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I have experienced rapid heartbeats originating from my ventricles.

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My cancer has mutations making it resistant to certain treatments.

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I do not have brain involvement with my lymphoma or a condition called PML.

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I need to take warfarin or a similar medication to prevent blood clots.

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I often feel dizzy or faint.

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I have ongoing and uncontrolled irregular heartbeats.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall response rate (complete response + partial response)

Secondary study objectives

Incidence of adverse events

Overall survival

Progression free survival

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (acalabrutinib)Experimental Treatment1 Intervention

Patients receive acalabrutinib PO BID on days 1-28. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acalabrutinib

2020

Completed Phase 2

~2050

0 / 31Eligibility criteria met