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Bruton's Tyrosine Kinase (BTK) Inhibitor

Acalabrutinib for Graft-versus-Host Disease

Phase 2
Recruiting
Led By Stephanie Lee
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%
Men and women ≥ 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 am 18 years old or older.
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I have been diagnosed with moderate to severe chronic GVHD.
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I am using effective birth control and will continue for 2 days after my last acalabrutinib dose.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best response (complete and partial response [CR + PR])
Secondary outcome measures
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
12%
Headache
2%
Respiratory failure
2%
Pneumonia
1%
Hypotension
1%
Acute kidney injury
1%
Pleural effusion
1%
Bacterial sepsis
1%
Mucosal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Acalabrutinib + BSC
BSC Alone

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
~2030

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,195 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,243 Previous Clinical Trials
288,527,722 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,165 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
10 Patients Enrolled for Graft-versus-Host Disease

Media Library

Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04198922 — Phase 2
Graft-versus-Host Disease Research Study Groups: Treatment (acalabrutinib)
Graft-versus-Host Disease Clinical Trial 2023: Acalabrutinib Highlights & Side Effects. Trial Name: NCT04198922 — Phase 2
Acalabrutinib (Bruton's Tyrosine Kinase (BTK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04198922 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this a pioneering clinical trial?

"Acalabrutinib has been studied extensively since its first trial in 2007, sponsored by Baxter Healthcare Corporation. This initial study of 4640 participants led to the drug's Phase 4 approval and today it is being explored within 107 trials across 49 countries and 1220 cities."

Answered by AI

Has the FDA given its blessing to Acalabrutinib?

"Due to the lack of clinical data in regards to efficacy, Acalabrutinib is estimated by our team at Power to have a safety rating of 2."

Answered by AI

Are there any vacancies left in this experiment for participants?

"As per the clinicaltrials.gov website, this medical research is actively enrolling patients with a start date of December 12th 2020 and an update posted on November 23rd 2022."

Answered by AI

Are there any extant experiments leveraging the drug Acalabrutinib?

"Currently, 107 scientific investigations are exploring the effects of Acalabrutinib. 14 of these trials have reached Phase 3, with Boston being a primary research hub; however, there are 889 locations worldwide that are enrolling patients for this treatment."

Answered by AI

What is the total participant count of this medical trial?

"The sponsor of this experiment, AstraZeneca, necessitates the recruitment of 50 suitable participants from two sites in Tennessee and Florida. Specifically, Moffitt Cancer Center in Tampa and Vanderbilt University Medical Centre in Nashville are hosting trial operations."

Answered by AI

How many health centers are administering this research project in the city?

"Participants can be recruited from Moffitt Cancer Center in Tampa, Florida; Vanderbilt University Medical Center located in Nashville, Tennessee; and The Ohio State University Wexner Medical Centre situated in Columbus, Ohio. In addition to these three sites, there are five other locations that are partaking in the trial."

Answered by AI
~10 spots leftby Jan 2025