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TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT

NCT07302776 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Vanessa Kennedy, MD · Stanford University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07302776 on ClinicalTrials.gov