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New study aims to outsmart relapse in aggressive blood cancers after transplant

NCT ID NCT07319793

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways of giving donor immune cells (DLI) after a stem cell transplant to prevent cancer from coming back in people with relapsed or hard-to-treat acute myeloid leukemia or myelodysplastic syndromes. One approach gives the cells early as a preventive measure, while the other waits for signs of remaining cancer. The trial will enroll 200 patients across multiple centers and track relapse rates, survival, and side effects like graft-versus-host disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Donor lymphocyte infusion (DLI) with short-course immunosuppressive therapy (cyclosporine A or methotrexate)
What this could lead to
If successful, this could establish a better way to prevent cancer relapse after stem cell transplant, improving survival for patients with aggressive blood cancers.
What could go wrong
This is an early-stage study with no phase assigned, so results are uncertain. The infusions can cause serious side effects like graft-versus-host disease or severe infections.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Eligible patients were those who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) for myeloid neoplasms (MN), excluding Philadelphia chromosome-positive (Ph+) disease, regardless of age. MN included acute myeloid leukemia (AML) and myelodysplastic syndrome with increased blasts (MDS-IB). Patients were required to have refractory or relapsed disease at the time of transplantation, defined as \>5% blasts in the bone marrow after salvage chemotherapy and prior to the transplant conditioning regimen. Additionally, patients must have achieved minimal residual disease (MRD)-negative remission within 1 month post-transplantation. All participants provided voluntary written informed consent. Exclusion Criteria: * Early mortality or relapse within 30 days post-transplantation. * Active graft-versus-host disease (GVHD) not under control between 30 and 60 days post-transplantation. * Presence of severe or uncontrolled infections. * Presence of significant organ dysfunction, defined as: Hepatic dysfunction: Known severe cirrhosis, portal hypertension, or active liver disease; or laboratory-confirmed alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3.0 × the upper limit of normal (ULN) and/or total bilirubin (TBIL) \> 1.5 × ULN. Renal dysfunction: Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73m² (calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation) or serum creatinine \> 1.5 × ULN; or requirement for regular hemodialysis or peritoneal dialysis. Cardiac dysfunction: New York Heart Association (NYHA) functional class III or IV; unstable angina, acute myocardial infarction, coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 6 months prior to enrollment; left ventricular ejection fraction (LVEF) \< 50% (confirmed by echocardiography or other Doppler examination); clinically significant, uncontrolled arrhythmia. Respiratory dysfunction: Chronic obstructive pulmonary disease (COPD) or other pulmonary disease requiring long-term oxygen therapy; resting oxygen saturation (SpO₂) \< 92% on room air. * Participation in another investigational drug trial within the 3 months prior to enrollment. * Any other condition deemed by the investigator to make the patient unsuitable for the study.

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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

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  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

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