About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tacrolimus
- Early Tacrolimus Taper Strategy
Treatment groups
Sponsors and collaborators
Stanford University
Lead sponsor
Eurofins Viracor Biopharma
Collaborator