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Monoclonal Antibodies

Axatilimab + Ruxolitinib for Graft-versus-Host Disease

Phase 2
Recruiting
Research Sponsored by Incyte Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
History of 1 allo-SCT with any type of stem cell donor, conditioning regimen, and source of hematopoietic stem cells
≥ 12 years of age at the time of informed consent
Must not have
Evidence of relapse of the primary hematologic disease or treatment for relapse after the allo-SCT was performed, including DLIs for the treatment of molecular relapse
Received previous systemic treatment for cGVHD, including systemic corticosteroids and extracorporeal photopheresis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test how well a new drug called axatilimab works when used together with ruxolitinib in people with chronic graft-versus-host disease (cGVHD).

Who is the study for?
This trial is for individuals aged 12 or older who have been newly diagnosed with moderate to severe chronic Graft-Versus-Host Disease (cGVHD) and need systemic therapy. They should not be dependent on platelet transfusions, have a certain level of white blood cells and platelets, and must commit to preventing pregnancy or fathering children.
What is being tested?
The study tests the safety and effectiveness of Axatilimab in combination with Ruxolitinib compared to standard treatments like corticosteroids for cGVHD. It aims to see if adding Axatilimab improves treatment outcomes.
What are the potential side effects?
Possible side effects include immune system reactions, infections due to lowered immunity from Ruxolitinib, bleeding issues, liver problems from Axatilimab, as well as general side effects like fatigue or nausea.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had one stem cell transplant from any donor.
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I am 12 years old or older.
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I have a new severe reaction from a transplant that needs treatment.
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My blood counts are stable without transfusions or medications for a week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My blood cancer has returned or I've been treated for a comeback after a stem cell transplant.
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I have been treated for chronic GVHD with steroids or photopheresis.
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I have chronic GVHD with some acute GVHD features.
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I have taken corticosteroids in the last 2 weeks.
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I have a history of pancreatitis.
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I do not have serious heart problems like uncontrolled high blood pressure or recent heart attacks.
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I am experiencing muscle pain or weakness.
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My liver isn't working well (high bilirubin or liver enzymes without liver disease).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate
Secondary study objectives
Axatilimab pharmacokinetic (PK) in Plasma
Best overall response in the first 6 months
Duration of Response
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Treatment Group CExperimental Treatment1 Intervention
Corticosteroids alone will be administered at a protocol defined starting dose.
Group II: Treatment Group BExperimental Treatment1 Intervention
Ruxolitinib will be administered at a protocol defined starting dose.
Group III: Treatment Group AExperimental Treatment2 Interventions
Axatilimab will be administered at a protocol defined starting dose plus ruxolitinib at a protocol defined starting dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Axatilimab
2017
Completed Phase 1
~50
Ruxolitinib
2018
Completed Phase 3
~1170
Corticosteroids
2003
Completed Phase 4
~8270

Find a Location

Who is running the clinical trial?

Incyte CorporationLead Sponsor
391 Previous Clinical Trials
63,715 Total Patients Enrolled
Incyte Medical MonitorStudy DirectorIncyte Corporation
33 Previous Clinical Trials
11,933 Total Patients Enrolled
~80 spots leftby Jun 2027
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