Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS Trial

Summary

This phase II trial studies how well adding axatilimab to standard of care (SOC) therapy works in preventing graft versus host disease (GVHD) following allogeneic hematopoietic stem cell transplantation (HCT) in patients with hematologic cancer. Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. Sometimes the transplanted cells from a donor can attack the body's normal cells, causing GVHD. Symptoms of GVHD can include yellowing of the skin, mucous membranes, and eyes, skin rash or blisters, dry mouth, or dry eyes. Typically, drugs such as cyclophosphamide, tacrolimus, and mycophenolate mofetil are given after the transplant to help stop GVHD from happening, but these current therapies may negatively affect patient quality of life and newer treatment strategies are needed. Axatilimab is a monoclonal antibody. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens), which may prevent GVHD from developing. Adding axatilimab to SOC therapy may be more effective in preventing GVHD following allogeneic HCT in patients with hematologic cancer.

Conditions

• Hematopoietic and Lymphatic System Neoplasm

Interventions

PROCEDURE

Allogeneic Hematopoietic Stem Cell Transplantation

Undergo SOC allogeneic HCT

BIOLOGICAL

Axatilimab

Given IV

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspiration

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Mycophenolate Mofetil

Given IV or PO

DRUG

Placebo Administration

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET

PROCEDURE

Skin Biopsy

Undergo skin biopsy

DRUG

Tacrolimus

Given tacrolimus

PROCEDURE

X-Ray Imaging

Undergo x-ray

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Saurabh Chhabra, MBBS, MS · Mayo Clinic

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-06-01

Primary Completion

2028-06-01

Completion

2033-06-01

FDA Drug

Yes

Countries

• United States

Study Locations