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

Conditions

• Hematopoietic and Lymphatic System Neoplasm

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Allogeneic Hematopoietic Stem Cell Transplantation — PROCEDURE
  Undergo SOC allogeneic HCT
• Axatilimab — BIOLOGICAL
  Given IV
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Bone Marrow Aspiration — PROCEDURE
  Undergo bone marrow aspiration
• Computed Tomography — PROCEDURE
  Undergo CT
• Cyclophosphamide — DRUG
  Given IV
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Mycophenolate Mofetil — DRUG
  Given IV or PO
• Placebo Administration — DRUG
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET
• Skin Biopsy — PROCEDURE
  Undergo skin biopsy
• Tacrolimus — DRUG
  Given tacrolimus
• X-Ray Imaging — PROCEDURE
  Undergo x-ray

Study Details

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.

Key Dates

Start date

Jun 1, 2026

Status verified

Apr 2026

Primary completion

Jun 1, 2028

Completion

Jun 1, 2033

Study Design

Enrollment

72 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: Stage 1 safety run-in (SOC GVHD prophylaxis, axatilimab)
  Patients undergo SOC allogeneic HCT on day 0 and receive SOC GVHD prophylaxis consisting of cyclophosphamide IV over 1-2 hours on days +3 and +4, tacrolimus starting on day +5 and tapered through day +90 to +100, and mycophenolate mofetil IV or PO TID on days +5 to +35 in the absence of disease progression or unacceptable toxicity. Starting on day +35, patients also receive axatilimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo x-ray or CT during screening and blood sample collection and bone marrow aspiration throughout the study. Patients may also undergo CT, MRI, or PET throughout the study and may optionally undergo skin biopsy on study.
• Experimental: Stage 2 arm I (SOC GVHD prophylaxis, axatilimab)
  Patients undergo SOC allogeneic HCT and receive SOC GVHD prophylaxis plus axatilimab as in stage 1 safety run-in in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo x-ray or CT during screening and blood sample collection and bone marrow aspiration throughout the study. Patients may also undergo CT, MRI, or PET throughout the study and may optionally undergo skin biopsy on study.
• Placebo Comparator: Stage 2 arm II (SOC GVHD prophylaxis, placebo)
  Patients undergo SOC allogeneic HCT on day 0 and receive SOC GVHD prophylaxis consisting of cyclophosphamide IV over 1-2 hours on days +3 and +4, tacrolimus starting on day +5 and tapered through day +90 to +100, and mycophenolate mofetil IV or PO TID on days +5 to +35 in the absence of disease progression or unacceptable toxicity. Starting on day +35, patients also receive placebo IV over 30 minutes on day 1 of each cycle. Cycles repeat every 14 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo x-ray or CT during screening and blood sample collection and bone marrow aspiration throughout the study. Patients may also undergo CT, MRI, or PET throughout the study and may optionally undergo skin biopsy on study.

Primary Outcome Measure

Graft versus host disease (GVHD)-free survival [ Time Frame: At 1 year post-transplant ]

Central Contacts

• Clinical Trials Referral Office
  855-776-0015
  [email protected]
• Cancer Center Clinical Trials
  507-293-6386

Locations (3)

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