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BET Inhibitor

BET Inhibitor for Graft-versus-Host Disease

Q: How many individuals are experiencing this treatment?

<p>That is accurate. The clinical trial in question was originally posted on 4/30/2022, and is currently recruiting 34 participants from 1 medical centre.</p>

Phase 1 & 2

Waitlist Available

Led By Ayman Saad, MB/BCH

Research Sponsored by Ayman Saad

Eligibility Criteria Checklist

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

Must have

Age >= 18 years at the time of signing informed consent

Recipients of ablative and reduced-intensity conditioning regimens

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of starting plx51107 to date of death with the competing risk as death due to disease, assessed at 6 months

Awards & highlights

Study Summary

This trial is testing the side effects of a new drug, PLX51107, for treating patients with a certain type of GVHD that has not responded to steroids. PLX51107 may work better than other drugs for this condition.

Who is the study for?

Adults with steroid-refractory acute GVHD after stem cell transplants who have an ECOG performance status of <=3, stable organ function, and no prior exposure to bromodomain inhibitors. Participants must not have chronic GVHD or active disease relapse, uncontrolled infections, significant cardiac issues, recent thrombotic events, inability to take oral medication properly, or be pregnant/breastfeeding.Check my eligibility

What is being tested?

The trial is testing PLX51107's effectiveness for treating steroid-refractory acute GVHD. It's a phase Ib/II study assessing the side effects of this novel BET inhibitor that selectively targets BRD4 and may offer a more tolerable side effect profile compared to other treatments.See study design

What are the potential side effects?

Specific side effects are not listed but as a new treatment under investigation; potential risks could include typical drug reactions such as nausea, fatigue, allergic responses or more serious complications related to organ inflammation or immune system suppression.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have undergone a bone marrow or stem cell transplant.

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I received a stem cell transplant from a closely matched donor or cord blood.

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I am capable of limited self-care and spend more than half of my waking hours out of bed.

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My white blood cell count has been stable for 3 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of starting plx51107 to date of death with the competing risk as death due to disease, assessed at 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of starting plx51107 to date of death with the competing risk as death due to disease, assessed at 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of starting plx51107 to date of death with the competing risk as death due to disease, assessed at 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse event

Maximum tolerated dose (MTD)

Secondary outcome measures

Complete response (CR)

Non-relapse mortality (NRM)

Overall response rate

Other outcome measures

Pharmacokinetics (PK) analysis

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment for aGVHD (BRD4 inhibitor PLX51107)Experimental Treatment1 Intervention

Patients receive BRD4 inhibitor PLX51107 PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BRD4 Inhibitor PLX51107

2019

Completed Phase 2

~50

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,665 Total Patients Enrolled

1 Trials studying Graft-versus-Host Disease

236 Patients Enrolled for Graft-versus-Host Disease

Ayman SaadLead Sponsor

2 Previous Clinical Trials

7 Total Patients Enrolled

Hannah ChoeLead Sponsor

Media Library

Graft-versus-Host Disease Clinical Trial 2023: PLX51107 Highlights & Side Effects. Trial Name: NCT04910152 — Phase 1 & 2

Frequently Asked Questions

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

How many individuals are experiencing this treatment?

"That is accurate. The clinical trial in question was originally posted on 4/30/2022, and is currently recruiting 34 participants from 1 medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Novel BET Inhibitor PLX51107 for Steroid-Refractory Acute GVHD

Hannah Choe 2022. "Novel BET Inhibitor PLX51107 for Steroid-Refractory Acute GVHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04910152.