ABRAXAS Trial: Axatilimab to Prevent GVHD After Stem Cell Transplant
This study, called the ABRAXAS Trial, is looking at whether adding axatilimab to standard care can help prevent graft versus host disease (GVHD) after an allogeneic hematopoietic stem cell transplant (HCT) for people with blood cancers. GVHD happens when the donor's cells attack your body. The study is open to adults aged 18 or older who have a blood cancer and are planning to have a myeloablative (high-dose chemotherapy) HCT. Researchers will measure how many people are free of GVHD one year after their transplant. The current recruitment status is unclear, but the study plans to enroll 72 participants.
- Study design
- This is a Phase II interventional study, meaning it tests a new treatment in a small group of people. It plans to enroll 72 participants.
- What's involved
- You would undergo a standard allogeneic HCT, receive axatilimab intravenously, and have blood samples, bone marrow aspirations, and CT scans taken.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least one year post-transplant to measure GVHD-free survival.
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NCT07349771
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
Withdrawn
PHASE2Ages 18+InterventionalPreventionMayo ClinicInvestigator-initiated
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:Allogeneic Hematopoietic Stem Cell TransplantationAxatilimabBiospecimen CollectionBone Marrow AspirationComputed TomographyCyclophosphamide
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Graft versus host disease (GVHD)-free survival
Measured over At 1 year post-transplant
Conditions
NCT07349771
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Mayo Clinic in Arizona
Scottsdale, Arizonano site contact published
Mayo Clinic in Florida
Jacksonville, Floridano site contact published
Mayo Clinic in Rochester
Rochester, Minnesotano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Saurabh Chhabra, MBBS, MS · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
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
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
What this trial measures
- Graft versus host disease (GVHD)-free survivalAt 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).