RecruitingPhase 1NCT07302776

TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT

TACTICAL: TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT

Sponsor

Stanford University

Enrollment

50 participants

Start Date

Jul 21, 2026

Study Type

INTERVENTIONAL

Conditions

GvHD Myelodysplastic Syndromes Chronic Myeloid Leukemia (CML)Acute Myeloid Leukemia (AML)Chronic Myelomonocytic Leukemia (CMML)Myelofibrosis (MF)Hematopoietic Cell Transplantation (HCT)

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Early Tacrolimus Taper Strategy and a drug called Tacrolimus for people with acute myeloid leukemia (aml), chronic myeloid leukemia (cml), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTacrolimus

Tacrolimus 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.

OTHEREarly Tacrolimus Taper Strategy

Eligible 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.