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Axatilimab for Graft-versus-Host Disease

(ABRAXAS Trial)

MC
Overseen ByMedical College of Wisconsin Cancer Center Clinical Trials Office
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Medical College of Wisconsin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a randomized, multisite, Phase II study designed to compare the 1-year GVHD-free survival of the control arm (no axatilimab) to the experimental arm (axatilimab) after myeloablative allogeneic HCT.

Who Is on the Research Team?

MH

Mehdi Hamadani, MD

Principal Investigator

Medical College of Wisconsin

SA

Sameem Abedin, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

This trial is for people who are getting a stem cell transplant from a matched donor to treat certain blood conditions. Participants must be eligible for this type of transplant and able to follow the study procedures.

Inclusion Criteria

Calculated creatinine clearance ≥30 mL/min using the Cockcroft-Gault formula
Willing to return to enrolling institution for follow-up during the Active Monitoring Phase
Patients with ≥5% blasts due to a regenerating marrow must contact the protocol chairs for review
See 12 more

Exclusion Criteria

Co-morbid systemic illnesses or severe concurrent disease making patient inappropriate for study or interfering with safety assessment
I have not had another cancer in the past 3 years, unless it was cured and approved by my doctor.
I have had serious heart problems or a heart attack in the past 6 months.
See 21 more

What Are the Treatments Tested in This Trial?

Interventions

  • Axatilimab

Trial Overview

The study compares standard care after stem cell transplant (using drugs like cyclophosphamide, tacrolimus, and MMF) with or without an added drug called axatilimab, to see if adding axatilimab helps prevent graft-versus-host disease over one year.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Safety Run-inExperimental Treatment5 Interventions
Group II: No Axatilimab TreatmentExperimental Treatment4 Interventions
Group III: Axatilimab TreatmentExperimental Treatment5 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials
645
Recruited
1,180,000+

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