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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
50
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.
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.
Stanford University
Palo Alto, California, United States
Safety and Feasibility of Early Tacrolimus Discontinuation
Proportion of patients who are low risk for acute graft-versus-host disease (aGVHD) who are able to discontinue tacrolimus by day 88 and who do not develop moderate to severe aGVHD by day 180.
Time frame: Day 0 through Day 180 post-transplant
Incidence and Severity of Chronic Graft-Versus-Host Disease
Proportion of participants who develop chronic graft-versus-host disease, reported as all grades and severe chronic graft-versus-host disease.
Time frame: Through 1 year after transplantation
Incidence of Non-Relapse Mortality
Incidence of death without relapse of the underlying disease.
Time frame: 1 year post-HCT
Incidence of Disease Relapse
Proportion of participants who experience relapse of their underlying disease.
Time frame: Through 1 year after transplantation
Overall Survival
Survival from the time of transplantation to death from any cause.
Time frame: Through 1 year after transplantation
Relapse-Free Survival
Time from transplantation to relapse of the underlying disease or death from any cause.
Time frame: Through 1 year after transplantation
Graft-Versus-Host Disease-Free, Relapse-Free Survival
Time to the first occurrence of grade III through IV acute graft-versus-host disease, chronic graft-versus-host disease requiring systemic therapy, relapse, or death.
Time frame: Through 1 year after transplantation
Incidence and Severity of Infectious Complications
Proportion of participants who develop infectious complications, reported as all grades, grade 2 through 3, and grade 3.
Time frame: Through 1 year after transplantation
Incidence and Severity of Acute Graft-Versus-Host Disease
Proportion of participants who develop acute graft-versus-host disease, reported as all grades, grade II through IV, and grade III through IV.
Time frame: Through Day 180 after transplantation
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