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Kinase Inhibitor

Belumosudil + Rituximab for Graft-versus-Host Disease

Phase 2

Recruiting

Led By Scott Solomon, MD

Research Sponsored by Northside Hospital, Inc.

Eligibility Criteria Checklist

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

Must have

Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC >750 cells/mm3; Platelets >30,000 cells/mm3

KPS >/= 70%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial studies a drug combo to treat a serious condition that affects bone marrow transplant patients.

Who is the study for?

This trial is for individuals with a new diagnosis of chronic Graft-Versus-Host Disease (cGVHD) who haven't been treated yet, or have had less than 10 days of corticosteroids. Participants must be in good physical condition (KPS >/= 70%) and have adequate blood cell counts without recent transfusions. People with HIV, active hepatitis B or C, severe liver issues, poor kidney function, uncontrolled infections or heart problems cannot join.Check my eligibility

What is being tested?

The study is testing the combination of two drugs—Belumosudil and Rituximab—as a primary treatment for cGVHD. It's an open-label Phase 2 trial which means everyone knows what treatment they're getting and it's fairly early in the testing process to see if it works well and is safe.See study design

What are the potential side effects?

While specific side effects are not listed here, Belumosudil may cause digestive issues, headaches, muscle pains; Rituximab can lead to infusion reactions like fever/chills, infections due to low white blood cells count, heart problems.

Eligibility Criteria

Inclusion Criteria

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

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My blood counts are within the required range without transfusions for a week.

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I am mostly able to care for myself and carry out daily activities.

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I have chronic GVHD needing systemic treatment for the first time.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Number of patients who achieve partial and complete responses after treatment

Secondary outcome measures

Length of time patients remain on corticosteroid treatment

Number of patients who had treatment-related adverse events using CTCAE v5

Trial Design

1Treatment groups

Experimental Treatment

Group I: Belumosudil Plus RituximabExperimental Treatment2 Interventions

Belumosudil plus Rituximab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Belumosudil

2018

Completed Phase 2

~320

Rituximab

1999

Completed Phase 4

~1880

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor

24 Previous Clinical Trials

1,066 Total Patients Enrolled

SanofiIndustry Sponsor

2,164 Previous Clinical Trials

3,514,955 Total Patients Enrolled

Scott Solomon, MDPrincipal InvestigatorBMTGA/Northside Hospital

6 Previous Clinical Trials

20,227 Total Patients Enrolled

Frequently Asked Questions

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

Is the combination of Belumosudil and Rituximab viewed as a secure treatment option for patients?

"With evidence of safety available, Belumosudil Plus Rituximab was rated a 2 on our scale. Since it is only in Phase 2 trial status, there is a lack of data confirming efficacy."

Answered by AI

Are there still slots available for individuals to participate in this trial?

"The information on clinicaltrials.gov reveals that this particular trial is not currently enlisting participants as it was last modified on September 21st 2023. However, there are 174 other medical studies actively searching for volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease

2024. "Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046248.

All > Graft Vs Host Disease