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Can umbilical cord blood keep leukemia at bay in older patients?

NCT ID NCT07761702

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This phase 3 trial is testing whether adding an umbilical cord blood infusion to standard consolidation chemotherapy can help older adults with intermediate- or high-risk acute myeloid leukemia (AML) stay free of relapse. About 132 patients aged 60 to 80 who achieved remission after initial treatment will be randomly assigned to receive either cord blood plus chemo or chemo alone, followed by maintenance therapy. The main goal is to see if the cord blood approach improves leukemia-free survival at two years.

What this could mean

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

Active substance
Unrelated umbilical cord blood infusion combined with decitabine, cytarabine, and azacitidine
What this could lead to
If successful, this approach could offer a new consolidation strategy to reduce relapse and improve survival in older AML patients who have limited treatment options.
What could go wrong
This is a randomized trial, but cord blood infusion carries risks like graft failure, infection, and immune reactions. Results may not apply to all AML subtypes, and the benefit over standard chemo is unproven.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 132 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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

60 to 80 years

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: 1. Age between 60 and 80 years old, inclusive. 2. Diagnosis of acute myeloid leukemia (AML) confirmed by bone marrow morphology and immunophenotyping, meeting all sub-criteria below: ① Bone marrow morphology: Bone marrow blasts \<5%, without features of leukemic infiltration; ② Cytogenetics: Carrying common chromosomal abnormalities including t(8;21), t(16;16), t(9;11), t(6;9), t(9;22), etc. Patients with t(15;17)(q22;q21) are excluded; ③ Molecular genetics: Harboring common fusion genes including AML1-ETO, CBFβ-MYH1, MLL-related fusions; patients with positive PML-RARα are excluded. Common gene mutations include NPM1, FLT3-ITD, CEBPA and c-kit; ④ Immunophenotyping: Single-lineage AML with a lymphoid antigen score of 0. 3. Achieved complete remission (CR), complete remission with partial hematologic recovery (CRh), or complete remission with incomplete hematologic recovery (CRi) after frontline induction chemotherapy; OR achieved CR/CRh/CRi followed by one cycle of consolidation with the original induction regimen. 4. Stratified as intermediate-risk or high-risk AML per the 2022 European LeukemiaNet (ELN) risk classification; patients with TP53 mutation or complex karyotype are excluded. 5. Adequate hepatic and renal function: total bilirubin ≤35 μmol/L; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2× upper limit of normal (ULN); serum creatinine ≤150 μmol/L. 6. Adequate cardiac function: resting left ventricular ejection fraction (LVEF) ≥50% on echocardiogram. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. Written informed consent signed by the patient and/or legal guardian. Exclusion Criteria: * 1.Confirmed diagnosis of acute promyelocytic leukemia (APL). 2.Relapsed or refractory AML, mixed-phenotype acute leukemia, or concomitant other hematological malignancies (including but not limited to lymphoma, multiple myeloma, immune thrombocytopenia (ITP), and other diseases whose treatment with immunosuppressants may interfere with immune reconstitution after cord blood infusion). 3.Known hypersensitivity to any study drug specified in the protocol. 4.Clear contraindication to chemotherapy as judged by the investigator. 5.History of other malignant tumors within the past 5 years, excluding cured basal cell carcinoma of the skin, localized cutaneous squamous cell carcinoma, cervical carcinoma in situ or breast carcinoma in situ. 6.Clinically significant active infection requiring systemic antibiotic therapy (including bacterial, viral and fungal infections) as assessed by the investigator, or seropositive for human immunodeficiency virus (HIV). 7.Active autoimmune diseases requiring systematic treatment within the past 2 years (e.g., diseases requiring corticosteroids or immunosuppressive agents). 8.Pregnant or breastfeeding female patients. 9.Unable to understand or comply with the study protocol. 10.Concurrent participation in another interventional clinical trial. 11.Any other condition that may hinder the implementation of the study, as determined by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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