NCT07302776

TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT

TACTICAL: TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Tacrolimus	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.
OTHER	Early 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.

Timeline

• Start date: 2026-06-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2025-12-24
• Last updated: 2026-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study