TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07302776
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tacrolimus — DRUG
    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.
  • Early Tacrolimus Taper Strategy — OTHER
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Feb 29, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Risk-Adapted Early Tacrolimus Taper Strategy
    Initial tacrolimus dosing will be as per Standard of Care protocol. Tacrolimus is initiated at day 5 post-HCT at with initial dosing as described in Section 6.2.3, and converted to oral formulation as soon as appropriate level is achieved and the patient are able to tolerate oral dosing. Oral tacrolimus is dosed in 0.5mg increments up to two times daily. Tacrolimus levels are assessed up to three times weekly in the inpatient or outpatient setting starting 1 - 3 days after initiation to target a level of 5 - 10 ng/mL. Trough levels will be assessed as close to 12 (twice daily dosing) or 24 (daily dosing) hours as feasible after most recent dose. Starting on day 60, patients on Stratum A will taper tacrolimus by approximately 20% of pre-taper dose per week, rounded to the nearest 0.5 mg. Participants who meet criteria and will be completely off tacrolimus by day 88 (+/- 5 days).

Primary Outcome Measure

Safety and Feasibility of Early Tacrolimus Discontinuation [ Time Frame: Day 0 through Day 180 post-transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Kelly Chyan
[email protected]
650-625-8130
Vanessa Kennedy, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Stanford University· Palo Alto, CA

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