New study aims to outsmart relapse in aggressive blood cancers after transplant
NCT ID NCT07319793
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
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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
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 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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Children (under 18), adults (18 to 64) and older adults (65 and over)
- 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 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
Only the study team decides who joins. These are the ways to reach them.
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?
- New drug combination targets Hard-to-Treat blood cancers