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New gentle chemo combo after transplant aims to stop leukemia relapse

NCT ID NCT06129734

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a low-dose, weekly chemotherapy combination (decitabine and venetoclax) given after a bone marrow transplant can help prevent high-risk myeloid cancers like acute myeloid leukemia from coming back. About 20 participants will receive the treatment for up to one year, alongside standard post-transplant care. The main goals are to see if this approach is safe and practical, and whether it improves survival without causing severe side effects.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of Acute myeloid leukemia, MDS, MDS/AML with high-risk for post-transplant relapse identified by: * Very high or high risk by CIBMTR Disease Risk Index (DRI) and/or adverse risk by ICC 2022 criteria and/or MDS/AML by ICC 2022 criteria. * Very high or high risk by CIBMTR DRI and/or by IPSS-M \> 0.510-12 and/or MDS/AML by ICC 2022 criteria. * Bone marrow myeloblasts \<5% at pre-transplant bone marrow aspirate and biopsy with no circulating blasts. * Participants must be planned for or have received alloSCT. Any conditioning regimen intensity or graft source (MRD/MUD/Haplo/UCB) is permitted. * Participants must be 18 years of age or older. * Total bilirubin \< 2.0 mg/dL (with the exception of participants with known Gilbert's syndrome, who should have direct bilirubin \< 2 × ULN). * Creatinine clearance (CrCl) \> 30 ml/min. * ECOG 0-1 performance status. * Subjects must have the ability to understand and the willingness to sign a written informed consent document and complete study related procedures. * Participants may enroll prior to or after alloSCT. Participants should enroll no later than post transplant day 40, and the the following post-AlloHSCT inclusion criteria must be met in order to initiate the maintenance study treatment: * Successful engraftment defined by absolute neutrophil count (ANC) of ≥500/ul and platelet count of ≥50,000/uL sustained for at least three consecutive days. * These criteria for engraftment should be met on or before Day +50. * No active infection * No GVHD ≥ overall grade II (Grade 1 GVHD of the skin acceptable). * Participants must continue to meet additional inclusion criteria * \<5% myeloblasts in a bone marrow aspirate with spicules, that is to be obtained, if all the above inclusion criteria are satisfied. Exclusion Criteria: * Prior disease progression on HMA/VEN therapy, single agent venetoclax. * Other planned post-transplant maintenance therapy, such as FLT3-ITD targeting agents, as determined by the treating physician * Currently pregnant or breast-feeding. Females of childbearing (FOCBP) potential must have negative serum pregnancy test within 72 hours from treatment start. (NOTE: FOCBP is any biologic female, regardless of sexual or gender orientation, having undergone tubal ligation, or remaining celibate by choice, who has not undergone a documented hysterectomy or bilateral oophorectomy or has had a menses any time in the preceding 12 months (therefore not naturally post-menopausal for \> 12 months) * Uncontrolled comorbid illness that could limit life expectancy or ability to complete study correlates. This includes, but is not limited to: * Active infection * Uncontrolled concurrent malignancy * Congestive heart failure of NYHA class III/IV. Participants with compensated heart failure are permitted. * Unstable angina pectoris * New or unstable cardiac arrhythmia. Stable or controlled arrhythmias are permitted * Decompensated liver cirrhosis (Child-Pugh score ≥12 or a MELD score ≥21 * Psychiatric illness/social situations that would limit compliance with study requirements. * Any other prior or ongoing condition, in the opinion of the investigator, that could adversely affect the safety of the participants or impair the assessment of study results. * FOCBP and males that are unwilling to agree to use dual contraceptive measures (i.e., hormonal or barrier method of birth control; abstinence, condom) prior to study entry and for the duration of study participation. Should a female subject become pregnant or suspect she is pregnant while participating in this study, they should inform the treating physician immediately * Sexually active male who is unwilling to use a condom when engaging in any sexual contact with a female with child-bearing potential, beginning at the screening visit and continuing until 4 weeks after taking the last dose of decitabine/venetoclax. * Participants with known active HIV infection, as this will further increase the risk for opportunistic infections. However, participants with chronic HIV with undetectable viral load by PCR, without opportunistic infection, and on a stable regimen of antiretroviral therapy would be eligible. * Known allergy or hypersensitivity to any component of decitabine/venetoclax

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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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • University Hospitals Seidman Cancer, Case Comprehensive Cancer Center

    RECRUITING

    Cleveland, Ohio, 44106, United States

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Other studies related to the condition(s) this trial covers.