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TACrolimus Targeted Immunosuppression Cessation in ALlogeneic HCT

Phase 1RecruitingNCT07302776
Stanford University50 enrolled

Overview

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

Conditions

GVHDHematopoietic Cell Transplantation (HCT)Acute Myeloid Leukemia (AML)Myelodysplastic SyndromesMyelofibrosis (MF)Chronic Myeloid Leukemia (CML)Chronic Myelomonocytic Leukemia (CMML)

Interventions

TacrolimusDRUG

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 StrategyOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years
Medical Language ↔ Plain English
Inclusion Criteria: * 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. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA). * 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. A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). -Ability to understand and the willingness to provide written informed consent. Exclusion Criteria: * 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: 1. Positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or 2. Presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) \>1000 by solid phase immunoassay. * 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. \*History of hepatitis B or hepatitis C is permitted if viral load is undetectable per quantitative PCR and/or NAT. Known allergy or hypersensitivity to planned GVHD prophylactic medications including PTCy, tacrolimus * 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. (FCBP definition: A female of childbearing potential (FCBP) is a female who: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). -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. \* All subject files must include supporting documentation to confirm subject eligibility.

Locations (1)

Stanford University

Palo Alto, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Kelly Chyan

CONTACT

650-625-8130kchyan@stanford.edu
Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.