TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorStanford University

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

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Stanford University

Lead sponsor

Eurofins Viracor Biopharma

Collaborator