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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib for Graft-versus-Host Disease

Phase 2

Recruiting

Led By Stephanie Lee, MD, MPH

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status ≥ 70%

Moderate-severe chronic GVHD, diagnosed per the 2014 National Institutes of Health (NIH) criteria

Must not have

Uncontrolled, active significant infection (e.g., bacterial, viral, fungal or progressive multifocal leukoencephalopathy)

Concurrent participation in another clinical trial and receiving a non-Food and Drug Administration (FDA) approved medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies the effectiveness of acalabrutinib in treating patients with chronic graft-versus-host disease.

Who is the study for?

This trial is for adults over 18 with moderate to severe chronic graft versus host disease (GVHD) after a stem cell transplant. They must understand the study, be able to swallow capsules, and have a performance status indicating they can carry out daily activities. Women who can bear children and men must use effective contraception. People with uncontrolled heart or blood conditions, recent major surgery, certain infections or cancers, or those on specific medications cannot join.

What is being tested?

The trial is testing Acalabrutinib's effectiveness in treating chronic GVHD following stem cell transplantation. It's a phase II study where participants will also complete questionnaires about their health status.

What are the potential side effects?

Potential side effects of Acalabrutinib may include bleeding problems, increased risk of infection due to immune system effects, possible liver issues indicated by changes in blood tests, and possibly other organ-related inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I am able to care for myself but may not be able to do active work.

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I have been diagnosed with moderate to severe chronic GVHD.

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I will not donate sperm during the study.

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My chronic GVHD symptoms got worse after steroid 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 any severe, untreated infections.

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I am not currently in another clinical trial or taking non-FDA approved drugs.

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I do not have active hepatitis B or C according to recent tests.

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I am being treated for chronic GVHD with ibrutinib.

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I was hospitalized for an infection in the last 8 weeks.

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

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My kidney function is reduced.

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My immune-suppressing medication has not changed in the last 2 weeks.

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I need warfarin or a similar medication.

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I have not had a live virus vaccine in the last 28 days.

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My liver tests are within normal limits, unless due to GVHD.

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I have been diagnosed with HIV.

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I have not had major surgery in the last 30 days or have fully recovered if I did.

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I do not have uncontrolled autoimmune blood disorders.

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My liver function is severely impaired.

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My platelet count is below 50 x 10^9/L or I've had a platelet transfusion recently.

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I cannot swallow pills well or have a stomach condition affecting medication absorption.

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My white blood cell count is low or I've used medication to increase it recently.

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I do not have active bleeding or a history of bleeding disorders.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

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

Best response (complete and partial response [CR + PR])

Secondary study objectives

Change in patient-reported outcomes: Lee Chronic GVHD Symptom Scale score

Change in patient-reported outcomes: Patient-Reported Outcomes Measurement Information System-29

Duration of response (DOR)

+3 more

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.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (acalabrutinib)Experimental Treatment2 Interventions

Patients receive acalabrutinib 100 mg PO BID on days 1-28. Treatment repeats every 28 days for up to 6 cycles with an option to continue for up to 24 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

~2080

0 / 23Eligibility criteria met