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.
Age ≥18 years.
Patients with a history of a hematologic malignancy with a planned myeloablative conditioning (MAC) peripheral blood allogeneic HCT.
Patients must be receiving an allograft from a suitable HLA-matched sibling or (7/8 or 8/8) unrelated donor according to transplant center's guidelines (for selection of appropriate donor).
Total bilirubin ≤1.5 x ULN or total bilirubin ≤3.0 x the Upper Limit of Normal (ULN) in the presence of Gilbert's syndrome. 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.
Pregnant persons.
Nursing persons.
Persons of childbearing potential, and persons able to father a child, who are unwilling to employ adequate contraception.
Patients receiving a cord blood transplant.
Parallel
Hematopoietic Cell Transplantation
Procedure/SurgerySubjects will receive a first HLA-matched related or (7/8 or 8/8) unrelated donor myeloablative allogeneic HCT.
Cyclophosphamide
DrugCyclophosphamide will be given on Day +3 and Day +4 per institutional practices, at a dose of 50 mg/kg IBW. Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume), or according to institutional standards.
Tacrolimus
DrugTacrolimus will be given per institutional practices, starting on Day +5. Subsequent dosing will be based on blood levels per institutional guidelines with a suggested range of 5-12 ng/mL.
Mycophenolate Mofetil (MMF)
DrugMycophenolate mofetil (MMF) will be given per institutional practices, at a dose of 15 mg/kg three times daily (TID; based upon actual body weight) with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day +5 and continue until Day +35 post-transplant, at which time it should be discontinued (no taper necessary).
Axatilimab
DrugThe dose is dependent on the results of the safety run-in. The starting dose of the safety run-in is 0.3 mg/kg (maximum of 35 mg). If Dose Level 1 has an unacceptable level of toxicity (≥2 patients having significant toxicity), then axatilimab may be de-escalated to 0.2 mg/kg (maximum of 23 mg).
GVHD-free survival
A patient will be considered a success for 1-year GVHD-free survival if they are alive without Grade 3 or 4 acute GVHD or systemic immunosuppression requiring chronic GVHD at one year post transplant. Death, Grade 3 or 4 acute GVHD, and immunosuppression-requiring chronic GVHD (of any severity) prior to 1 year will be considered as events.
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