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
April 15, 2026 updated by: Mayo Clinic
Phase II Double-Blinded Placebo-Controlled Randomized Trial of CSF-1R Inhibitor, Axatilimab for Prevention of Acute and Chronic GVHD After HLA-Matched Related and Unrelated Donor Allogeneic Stem Cell Transplantation (ABRAXAS)
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
- Procedure: Magnetic Resonance Imaging
- Procedure: Computed Tomography
- Procedure: Biospecimen Collection
- Drug: Cyclophosphamide
- Procedure: Positron Emission Tomography
- Procedure: Bone Marrow Aspiration
- Drug: Placebo Administration
- Procedure: X-Ray Imaging
- Drug: Mycophenolate Mofetil
- Drug: Tacrolimus
- Biological: Axatilimab
- Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
- Procedure: Skin Biopsy
Study Type
Interventional
Enrollment (Estimated)
72
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Contact Backup
- Name: Cancer Center Clinical Trials
- Phone Number: 507-293-6386
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Mayo Clinic in Arizona
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Contact:
- Cancer Center Clinical Trials
- Phone Number: 507-293-6386
-
Principal Investigator:
- Saurabh Chhabra, MBBS, MS
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Mayo Clinic in Florida
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Contact:
- Cancer Center Clinical Trials
- Phone Number: 507-293-6386
-
Principal Investigator:
- Madiha Iqbal, MD
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
Principal Investigator:
- Hassan Alkhateeb, MD
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Contact:
- Cancer Center Clinical Trials
- Phone Number: 507-293-6386
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age ≥ 18 years
Patients with a history of a hematologic malignancy with a planned myeloablative conditioning (MAC) peripheral blood allogeneic HCT
- Note: Patients with acute leukemia must be in morphologic complete remission with or without hematologic recovery with ˂ 5% blasts in the bone marrow. Patients with chronic myelomonocytic leukemia (CMML) must have a white blood cell (WBC) count ≤ 10,000 cells/µL and < 5% blasts in the marrow. Patients with ≥ 5% blasts due to a regenerating marrow must contact the protocol chairs for review. Patients with a diagnosis of myelofibrosis require sponsor approval before enrolling
- Patients must be receiving an allograft from a suitable human leukocyte antigen (HLA)-matched sibling or unrelated donor according to transplant center's guidelines (for selection of appropriate donor)
- Karnofsky performance status ≥ 60
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or total bilirubin ≤ 3.0 x the ULN in the presence of Gilbert's syndrome (obtained ≤ 14 days prior to registration/randomization). If total bilirubin is abnormal (≥ 1.5 x ULN), assess direct bilirubin. NOTE: Patients with Gilbert syndrome and elevated baseline unconjugated (indirect) bilirubin up to 3.0 mg/dL are eligible. Gilbert syndrome should be confirmed by the presence of UGT1A1*28 variant
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN (obtained ≤ 14 days prior to registration/randomization)
- Calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault formula (obtained ≤ 14 days prior to registration/randomization)
- Negative serum pregnancy test done ≤ 7 days prior to registration/randomization, for persons of childbearing potential only
Sexually active patients and their partners must use an effective method of contraception associated with a low failure rate prior to study entry and for the duration of study participation and for at least 3 months after the last dose of study drug
- Note: The following are considered effective contraceptives: oral contraceptive pill; condom plus spermicide; diaphragm plus spermicide; patient or partner surgically sterile; patient or partner more than 12 months postmenopausal; or injectable or implantable agent/device. Male patients should refrain from sperm donation and female patients should refrain from breastfeeding throughout this period
- Provide written informed consent
- Willingness to provide mandatory blood and bone marrow aspirate specimens for correlative research
- Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
Exclusion Criteria:
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effect on the developing fetus and newborn are unknown:
- Pregnant persons
- Nursing persons
- Persons of childbearing potential, and persons able to father a child, who are unwilling to employ adequate contraception
Any of the following current or prior therapies:
- Patients receiving a cord blood transplant
- Patients undergoing a T-cell depleted allogeneic transplantation (using ex vivo CD34 selection, or with serotherapy [antithymocyte globulin or alemtuzumab])
- Patients undergoing a second allogeneic transplant (after a previous allogeneic transplant)
- Pre-planned treatment with JAK1/JAK2 inhibitor after transplant
- Previous exposure to axatilimab
- Currently participating in any other interventional study
- Receiving an investigational treatment ≤ 28 days prior to registration/randomization
- Major surgery ≤ 3 weeks prior to registration/randomization
- Chemotherapy ≤ 2 weeks prior to registration/randomization unless chemotherapy is part of the pre-transplant conditioning
- Radiation therapy ≤ 2 weeks prior to registration/randomization unless radiation is part of the pre-transplant conditioning
- Planned use of donor lymphocyte infusion (DLI) therapy
- Exception: Use of maintenance regimens as routine clinical care will be permitted but must be declared prior to registration/randomization. The trial does not restrict subsequent treatment after meeting the GVHD-free survival (GFS) endpoint
- Active central nervous system (CNS) involvement by malignant cells
- Leukemia involvement in the CNS ≤ 4 weeks of registration for patients with a history of prior CNS leukemia involvement (i.e., leukemic blasts previously detected in the cerebral spinal fluid)
- History of acute or chronic pancreatitis
- History of myositis
- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
Patients with active hepatitis B or C
- Patients with a history of hepatitis B or C are allowed if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) or hepatitis C virus (HCV) RNA are undetectable
- Any known infection with human immunodeficiency virus (HIV), human T-lymphotropic virus-1 (HTLV-1)
- Uncontrolled bacterial, viral, or fungal infections (currently taking medication and with progression or no clinical improvement) at the time of registration/randomization
- Psychiatric illness/social situations that would limit compliance with study requirements
- Diagnosed with another malignancy (other than malignancy for which transplant was performed) ≤ 3 years of registration/randomization, unless previously treated with curative intent and approved by principal investigator (PI) (e.g., but not limited to completely resected basal cell, squamous cell, or ductal carcinoma in situ, or low-risk prostate cancer after curative resection or on watchful waiting). In patients with transformed disease (e.g. aggressive lymphoma evolving from chronic lymphocytic leukemia [CLL], or acute leukemia from myelodysplastic syndrome [MDS]), the original hematological disorder is not considered an exclusion. Cancer treated with curative intent < 3 years previously will not be allowed unless approved by the study chairs
- History of myocardial infarction ≤ 6 months, or New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Undergo PET
Other Names:
Undergo bone marrow aspiration
Undergo x-ray
Other Names:
Given IV or PO
Other Names:
Given tacrolimus
Other Names:
Given IV
Other Names:
Undergo SOC allogeneic HCT
Other Names:
Undergo skin biopsy
Other Names:
|
|
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.
|
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Undergo PET
Other Names:
Undergo bone marrow aspiration
Undergo x-ray
Other Names:
Given IV or PO
Other Names:
Given tacrolimus
Other Names:
Given IV
Other Names:
Undergo SOC allogeneic HCT
Other Names:
Undergo skin biopsy
Other Names:
|
|
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.
|
Undergo MRI
Other Names:
Undergo CT
Other Names:
Undergo blood sample collection
Other Names:
Given IV
Other Names:
Undergo PET
Other Names:
Undergo bone marrow aspiration
Given IV
Undergo x-ray
Other Names:
Given IV or PO
Other Names:
Given tacrolimus
Other Names:
Undergo SOC allogeneic HCT
Other Names:
Undergo skin biopsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Graft versus host disease (GVHD)-free survival
Time Frame: At 1 year post-transplant
|
Rates will be compared between the two arms.
A patient will be considered a success for 1-year GVHD-free survival if they are alive without grade 3 or 4 acute or systemic immunosuppression-requiring chronic GVHD at one year post myeloablative allogeneic hematopoietic cell transplantation (HCT).
|
At 1 year post-transplant
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cumulative incidence of mild, moderate, and severe chronic GVHD
Time Frame: Up to 1 year post-transplant
|
As assessed by National Institutes of Health criteria.
Will be estimated in each arm using the competing risk model, with death without chronic GVHD as a competing risk event.
Differences between arms will be evaluated using Cox proportional hazard models with competing risk.
|
Up to 1 year post-transplant
|
|
Cumulative incidence of systemic corticosteroid requiring chronic GVHD
Time Frame: Up to 1 year post-transplant
|
Will be estimated in each arm using the competing risk model, with death without chronic GVHD requiring systemic corticosteroids as a competing risk event.
Differences between arms will be evaluated using Cox proportional hazard models with competing risks.
|
Up to 1 year post-transplant
|
|
Cumulative incidence of grade II-IV and III-IV acute GVHD
Time Frame: At 100 days and 180 days
|
Will be estimated in each arm using the competing risk model, with death without grade II-IV or III-IV acute GVHD as a competing risk events respectively.
Differences between arms will be evaluated using Cox proportional hazard models with competing risks.
|
At 100 days and 180 days
|
|
Cumulative incidence of non-relapse mortality
Time Frame: Up to 1 year post-transplant
|
Will be estimated in each arm using the competing risk model, with relapse/progression as a competing risk event.
Differences between arms will be evaluated using Cox proportional hazard models with competing risks.
|
Up to 1 year post-transplant
|
|
Incidence of primary and secondary graft failure
Time Frame: At 30 days, 60 days, 100 days, 180 days, and 365 days
|
Will be estimated in each arm by the number of patients who experience graft failure divided by the total number of evaluable patients.
Exact binomial 95% confidence intervals for the true success rate will be calculated.
Differences in rates between arms will be evaluated using Fisher's exact test.
|
At 30 days, 60 days, 100 days, 180 days, and 365 days
|
|
Cumulative incidence of relapse/progression of the primary hematologic malignancy
Time Frame: Up to 2 years
|
Will be estimated in each arm using the competing risk model, with death without relapse/progression as a competing risk event.
Differences between arms will be evaluated using Cox proportional hazard models with competing risks.
|
Up to 2 years
|
|
Lineage specific chimerism kinetics
Time Frame: At 30 days, 100 days, 180 days, and 365 days
|
The percentage of donor versus recipient cells will be evaluated for T cells (CD3+), myeloid cells (CD33+), B cells (CD19+), and NK cells (CD56+) at each time point to assess lineage specific chimerism kinetics.
The percentages will be categorized for each cell type as full recipient (≤ 5%), mixed (6-94%), or full donor (≥ 95%).
Values will be summarized descriptively (median, range, distribution across categories) and changes across time will be evaluated.
|
At 30 days, 100 days, 180 days, and 365 days
|
|
Immune reconstitution
Time Frame: At 30 days, 100 days, 180 days, and 365 days
|
Immune profiles (including helper T cells (CD3+ CD4+), cytotoxic T cells (CD3+ CD8+), regulatory T cells (CD3+ CD4+ CD25+ CD127low/-FOXP3+), B cells (CD19+) will be evaluated at each time point to assess immune reconstitution following transplant.
Values at each time point will be summarized descriptively (median, range) and changes across time will be evaluated.
|
At 30 days, 100 days, 180 days, and 365 days
|
|
Progression-free survival
Time Frame: Up to 2 years post-transplant
|
Defined as the time from transplant to the earliest date of documentation of relapse/progression or death due to any cause.
|
Up to 2 years post-transplant
|
|
Overall survival
Time Frame: Up to 2 years post-transplant
|
Defined as the time from transplant to death due to any cause.
|
Up to 2 years post-transplant
|
|
Incidence of adverse events
Time Frame: Up to 2 years post-transplant
|
Assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed for each arm to determine patterns.
Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration.
|
Up to 2 years post-transplant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Saurabh Chhabra, MBBS, MS, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2033
Study Registration Dates
First Submitted
January 15, 2026
First Submitted That Met QC Criteria
January 15, 2026
First Posted (Actual)
January 20, 2026
Study Record Updates
Last Update Posted (Actual)
April 16, 2026
Last Update Submitted That Met QC Criteria
April 15, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Organic Chemicals
- Investigative Techniques
- Therapeutics
- Fatty Acids
- Lipids
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Surgical Procedures, Operative
- Hydrocarbons
- Physical Phenomena
- Acids, Acyclic
- Carboxylic Acids
- Transplantation
- Equipment and Supplies
- Chemistry Techniques, Analytical
- Macrolides
- Lactones
- Spectrum Analysis
- Phosphoramide Mustards
- Nitrogen Mustard Compounds
- Mustard Compounds
- Hydrocarbons, Halogenated
- Phosphoramides
- Organophosphorus Compounds
- Electromagnetic Phenomena
- Magnetic Phenomena
- Cell Transplantation
- Cell- and Tissue-Based Therapy
- Biological Therapy
- Electromagnetic Radiation
- Radiation
- Radiation, Ionizing
- Caproates
- Cyclophosphamide
- Mycophenolic Acid
- Tacrolimus
- Specimen Handling
- Magnetic Resonance Spectroscopy
- Stem Cell Transplantation
- X-Rays
- axatilimab
- Phantoms, Imaging
Other Study ID Numbers
- MC230810 (Mayo Clinic)
- 24-009803 (Other Identifier: Mayo Clinic Institutional Review Board)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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