Can patients stop Anti-Rejection drugs sooner after transplant?
NCT ID NCT07302776
First seen Jun 25, 2026 · Last updated Aug 18, 2026 · Updated 3 times
Summary
This study tests whether patients can safely stop the drug tacrolimus earlier than usual after a stem cell transplant. Tacrolimus is given to prevent graft-versus-host disease (GVHD), but newer methods have lowered GVHD risk. The trial will enroll 50 people with blood cancers and see if tapering off tacrolimus by day 88 is safe and does not cause severe GVHD by day 180.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tacrolimus
- What this could lead to
- If successful, this could show that stopping immunosuppression earlier after transplant is safe, potentially reducing side effects and improving recovery.
- What could go wrong
- This is a small, early-phase trial. Early tapering may increase the risk of graft-versus-host disease, which can be serious. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Stanford University
RECRUITINGPalo Alto, California, 94304, United States
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- Blood cancer registry tracks thousands to map disease course