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Acalabrutinib for Graft-versus-Host Disease
Study Summary
This trial studies the effectiveness of acalabrutinib in treating patients with chronic graft-versus-host disease.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 2 trial • 177 Patients • NCT04346199Trial Design
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Who is running the clinical trial?
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- I do not have any severe, untreated infections.I am not currently in another clinical trial or taking non-FDA approved drugs.I am able to care for myself but may not be able to do active work.I do not have active hepatitis B or C according to recent tests.I am being treated for chronic GVHD with ibrutinib.Not following the study rules.I was hospitalized for an infection in the last 8 weeks.I need treatment with a strong medication that affects liver enzymes.My kidney function is reduced.I am 18 years old or older.My immune-suppressing medication has not changed in the last 2 weeks.I do not have serious heart problems or recent heart attacks.I need warfarin or a similar medication.I have not had a live virus vaccine in the last 28 days.My liver tests are within normal limits, unless due to GVHD.I have been diagnosed with HIV.I have not had major surgery in the last 30 days or have fully recovered if I did.I do not have uncontrolled autoimmune blood disorders.I have been diagnosed with moderate to severe chronic GVHD.My liver function is severely impaired.I have no active cancer except for certain skin cancers or cancers I've been free of for 2+ years.My platelet count is below 50 x 10^9/L or I've had a platelet transfusion recently.I cannot swallow pills well or have a stomach condition affecting medication absorption.My white blood cell count is low or I've used medication to increase it recently.I am using effective birth control and will continue for 2 days after my last acalabrutinib dose.I will not donate sperm during the study.I have not had a stroke or brain bleed in the last 6 months.I do not have active bleeding or a history of bleeding disorders.My chronic GVHD symptoms got worse after steroid treatment.
- Group 1: Treatment (acalabrutinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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