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Belumosudil + Corticosteroids for Chronic Graft Versus Host Disease (ROCKnrol-1 Trial)

Phase 3

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

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

Must have

Patients must be at least 12 years of age inclusive, at the time of signing the informed consent

Participants who have undergone allogenic HCT with newly diagnosed moderate to severe cGVHD according to NIH consensus diagnosis and staging criteria (2014)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until the end of the study (up to 5 years since first patient in).

Awards & highlights

ROCKnrol-1 Trial Summary

This trial is testing a new treatment for a chronic immune disorder. It involves screening, treatment, follow-up, and long-term monitoring.

Who is the study for?

This trial is for people at least 12 years old with a body weight of ≥40kg who have moderate to severe chronic Graft Versus Host Disease (cGVHD) after an allogeneic HCT. They must need systemic corticosteroid treatment and not have had prior cGVHD treatments, except possibly corticosteroids within the last 7 days. Participants should be able to consent and follow contraception guidelines.Check my eligibility

What is being tested?

The study tests Belumosudil combined with corticosteroids against a placebo plus corticosteroids in treating newly diagnosed cGVHD. It's a Phase 3 trial where participants are randomly assigned to one of two groups and treated until their condition progresses or they experience unacceptable side effects.See study design

What are the potential side effects?

While specific side effects for Belumosudil aren't listed, common ones from similar medications may include stomach issues, liver enzyme changes, blood pressure variations, fatigue, risk of infection, and potential allergic reactions.

ROCKnrol-1 Trial Eligibility Criteria

Inclusion Criteria

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

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I am 12 years old or older.

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I have had a stem cell transplant and now have moderate to severe chronic graft-versus-host disease.

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I need steroids for chronic graft-versus-host disease.

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I have not had any treatment for chronic GVHD.

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My body weight is 40kg or more.

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I can sign the consent form myself or have someone who can legally do it for me.

ROCKnrol-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until the end of the study (up to 5 years since first patient in).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until the end of the study (up to 5 years since first patient in).

This trial's timeline: 3 weeks for screening, Varies for treatment, and until the end of the study (up to 5 years since first patient in). for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Event-Free Survival (EFS)

Secondary outcome measures

Change in patient reported outcome (PRO)

Dose reduction in corticosteroid

Duration of response (DOR)

+8 more

ROCKnrol-1 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BelumosudilExperimental Treatment3 Interventions

Participants will receive belumosudil 200 mg tablets Per os(PO) once daily (QD) per 28-day cycles starting on Day 1 until discontinuation criteria are met or until end of study note: 200mg two times a day (BID) is used in some cases, when the subject is taking a proton pump inhibitor or a strong CYP3A4 inducer)

Group II: PlaceboPlacebo Group3 Interventions

Participants will receive matching placebo tablets PO QD per 28-day cycles starting on Day 1 until discontinuation criteria are met or until end of study

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belumosudil

2018

Completed Phase 2

~320

Prednisone

2014

Completed Phase 4

~2370

Prednisolone

2005

Completed Phase 4

~2720

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,740 Total Patients Enrolled

Frequently Asked Questions

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

Has Belumosudil received final authorization from the FDA?

"A score of 3 was assigned to Belumosudil's safety due the data accumulated from its Phase 3 trial, which alludes to efficacy and multiple rounds of supportive evidence."

Answered by AI

How many people is this clinical trial accepting as participants?

"Affirmative. The information compiled on clinicaltrials.gov confirms that this trial is actively looking for participants; the trial was first posted on November 30th 2023 and updated most recently on November 23rd 2023. 240 volunteers are required from one medical centre alone."

Answered by AI