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Early Tacrolimus Cessation After Stem Cell Transplant

This study is testing if it's safe and possible to stop taking tacrolimus early after an allogeneic hematopoietic cell transplant (HCT), also known as a stem cell transplant. Tacrolimus is a medicine usually given to prevent graft-versus-host disease (GVHD), a complication where the new immune cells attack the patient's body. Because modern transplant methods have reduced GVHD rates, researchers want to see if patients can safely stop tacrolimus sooner. You might be able to join if you are 18-80 years old and have certain types of acute myeloid leukemia (AML) or myelodysplastic syndromes. The study will look at how safe and practical this early stopping strategy is for 180 days after your transplant. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 50 participants. It is testing a specific strategy for reducing tacrolimus.
What's involved
You would start tacrolimus around Day 5 after your transplant. If eligible, you would begin reducing your tacrolimus dose around Day 60, aiming to stop by Day 88.
Compensation
Not stated in the trial record.
Follow-up
Your safety and the feasibility of the early tacrolimus discontinuation will be measured from Day 0 through Day 180 post-transplant.

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NCT07302776

TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT

Recruiting
PHASE1Ages 18–80InterventionalSupportive care
Stanford University
~50 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:TacrolimusEarly Tacrolimus Taper Strategy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Feasibility of Early Tacrolimus Discontinuation
Measured over Day 0 through Day 180 post-transplant

Conditions

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

Explore related trials

Acute Myeloid LeukemiaChronic Myeloid Leukemia, BCR-ABL1 PositiveChronic Myelomonocytic LeukemiaMyelodysplastic SyndromeMyelofibrosis

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Vanessa Kennedy, MD · PRINCIPAL_INVESTIGATOR · Stanford University

Who to contact

Kelly Chyan
[email protected]
650-625-8130
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Eligible diseases:
Acute myeloid leukemia (AML) in complete remission (CR), CR with incomplete hematologic recovery (CRi), or MLFS.
Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT based on IPSS-M of intermediate or higher, or IPSS-R of intermediate or higher, or refractory disease to standard growth factor or hypomethylating agent-based therapy
Myelofibrosis (MF)
Chronic myeloid leukemia (CML) in chronic phase with a prior history of accelerated phase or blast crisis or CML in chronic phase refractory to standard TKI therapy
Chronic myelomonocytic leukemia (CMML)
Age ≥ 18 and ≤ 80 years at the time of enrollment.
Planned for first myeloablative or reduced intensity allogenic transplant using a conditioning regimen listed in Appendix B.
Has a related or unrelated donor available who is 8/8 HLA match at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods.
Estimated glomerular filtration rate (eGFR) ≥ 50 mL/minute or creatinine \< 2 mg/dL.
Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%.
Total bilirubin \< 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included once hemolysis has been excluded).
Karnofsky Performance Score ≥70%
Negative serum or urine beta-HCG test in females of childbearing potential (FCBP) within 3 weeks of enrollment.
Ability to understand and the willingness to provide written informed consent.

Exclusion

Prior allogeneic HCT.
Planned donor lymphocyte infusion (DLI).
Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:
Uncontrolled bacterial, viral, or fungal infections at time of enrollment including known, active tuberculosis infection.
Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, and/or Hepatitis C antibody.
Any uncontrolled autoimmune disease requiring active immunosuppressive treatment.
Concurrent malignancy diagnosed within 12 months of enrollment, except non-melanoma skin cancers or other early-stage solid tumors that have been curatively resected or treated to curative intent. Patients with history of low grade concurrent blood cancers that are controlled will be eligible.
Females of childbearing potential (FCBP) or men who have sexual contact with FCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation.
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the recipient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.

What this trial measures

  • Safety and Feasibility of Early Tacrolimus DiscontinuationDay 0 through Day 180 post-transplant

    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.