The purpose of this study is to test the feasibility and safety of early cessation of tacrolimus following allogeneic hematopoietic cell transplantation (HCT). Post-HCT tacrolimus is given to prevent graft-vs-host-disease (GVHD), but with the use of post-transplant cyclophosphamide (PTCy), the modern approach to GVHD prevention, GVHD rates have reduced markedly.
Acute myeloid leukemia (AML) in complete remission (CR), CR with incomplete hematologic recovery (CRi), or MLFS.
Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT based on IPSS-M of intermediate or higher, or IPSS-R of intermediate or higher, or refractory disease to standard growth factor or hypomethylating agent-based therapy
Myelofibrosis (MF)
Chronic myeloid leukemia (CML) in chronic phase with a prior history of accelerated phase or blast crisis or CML in chronic phase refractory to standard TKI therapy
Prior allogeneic HCT.
Planned donor lymphocyte infusion (DLI).
Positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or
Presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) >1000 by solid phase immunoassay.
Single group
Tacrolimus
DrugTacrolimus is initiated on Day 5 post-HCT and transitioned to oral dosing once therapeutic levels are achieved. Oral tacrolimus is given in 0.5 mg increments up to twice daily. Levels are monitored several times weekly to target a trough of 5-10 ng/mL.
Early Tacrolimus Taper Strategy
Other interventionEligible participants begin a taper on Day 60 (±5 days), reducing the tacrolimus dose by \~20% weekly, rounded to 0.5 mg, with planned discontinuation by Day 88 (±5 days). Tapering stops if significant acute GVHD develops or if unsafe.
Safety and Feasibility of Early Tacrolimus Discontinuation
Proportion of patients who are low risk for acute graft-versus-host disease (aGVHD) who are able to discontinue tacrolimus by day 88 and who do not develop moderate to severe aGVHD by day 180.
Incidence and Severity of Chronic Graft-Versus-Host Disease
Proportion of participants who develop chronic graft-versus-host disease, reported as all grades and severe chronic graft-versus-host disease.
Incidence of Non-Relapse Mortality
Incidence of death without relapse of the underlying disease.
Incidence of Disease Relapse
Proportion of participants who experience relapse of their underlying disease.
Overall Survival
Survival from the time of transplantation to death from any cause.
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Stanford University
Lead sponsor
Eurofins Viracor Biopharma
Collaborator
