AML (Acute Myelogenous Leukemia)Phase 3NCT07761702
Umbilical Cord Blood Consolidation for Older Adults With Intermediate- and High-Risk AML
A Phase 3 study testing Unrelated Umbilical Cord Blood Infusion and Standard consolidation chemotherapy with high-dose cytarabine in people with AML (Acute Myelogenous Leukemia), run by Shanghai Jiao Tong University School of Medicine.
Trial summary
Acute myeloid leukemia (AML) is a serious blood cancer that commonly affects older adults. Although patients may achieve complete remission after initial treatment, relapse remains common, especially in patients with intermediate- or adverse-risk disease. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- AML (Acute Myelogenous Leukemia)
- What is being tested?
- Unrelated Umbilical Cord Blood Infusion and Standard consolidation chemotherapy with high-dose cytarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 60 and 80 years old, inclusive.
- 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.
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- 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.
- 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.
- 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.
- Adequate cardiac function: resting left ventricular ejection fraction (LVEF) ≥50% on echocardiogram.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. Written informed consent signed by the patient and/or legal guardian.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized-Controlled Study of Cord Blood Consolidation Therapy for Intermediate- and High-Risk Elderly Acute Myeloid Leukemia
Acute myeloid leukemia (AML) is a serious blood cancer that commonly affects older adults. Although patients may achieve complete remission after initial treatment, relapse remains common, especially in patients with intermediate- or adverse-risk disease.
This prospective, multicenter, randomized, open-label study will evaluate whether umbilical cord blood infusion used as consolidation therapy can improve outcomes in older patients with AML who have achieved complete remission after induction therapy. The study will enroll approximately 132 patients aged 60 to 80 years with newly diagnosed AML classified as intermediate or adverse risk according to the 2022 European LeukemiaNet criteria. Patients with acute promyelocytic leukemia, TP53 mutations, complex karyotypes, relapsed or refractory AML, or other conditions specified in the eligibility criteria will be excluded.
Read more
Participants will be randomly assigned in a 2:1 ratio to an experimental group or a control group. Participants in the experimental group will receive two cycles of consolidation treatment with decitabine, intermediate-dose cytarabine, and unrelated umbilical cord blood infusion. After completion of the two cord blood infusions, maintenance treatment with azacitidine will be recommended for up to 12 months. Participants in the control group will receive two cycles of standard consolidation chemotherapy with intermediate-dose cytarabine, followed by the same recommended azacitidine maintenance treatment.
Participants will be followed during maintenance treatment and for up to 2 years after consolidation therapy, or until disease progression, relapse, death, or another study endpoint occurs. The primary outcome is the proportion of participants who remain alive without leukemia relapse or additional anti-leukemia treatment at 2 years. Secondary outcomes include overall survival, conversion of measurable residual disease to negative status and duration of negativity, recovery of neutrophil and platelet counts, treatment-related mortality, and blood-related and non-blood-related toxicities. Exploratory outcomes include donor cell chimerism, immune status, and, where available, single-cell RNA sequencing or RNA sequencing results.
- Conditions
- AML (Acute Myelogenous Leukemia)
- Being tested
- Unrelated Umbilical Cord Blood Infusion, Standard consolidation chemotherapy with high-dose cytarabine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unrelated Umbilical Cord Blood InfusionBiological
Subjects in the experimental arm receive consolidation chemotherapy with decitabine plus cytarabine, followed by unrelated cord blood infusion, then maintenance azacitidine after completion of two cord blood infusions.
Decitabine is administered at 15 mg/m² per day intravenously on Days 1-5 of each consolidation cycle. Cytarabine 1.0 g/m² is given intravenously every 12 hours on Days 6-7 of each cycle. Unrelated umbilical cord blood (UCB) is infused on Day 9 of each consolidation cycle. UCB eligibility criteria: total nucleated cell (TNC) count >3×10⁷/kg pre-cryopreservation, HLA matching at 4/6 to 5/6 loci, ABO and Rh blood type compatibility preferred.
The above consolidation regimen is repeated on Day 30 (counting Day 1 of decitabine as cycle Day 1), or earlier upon hematologic recovery. After completing two UCB infusions, maintenance therapy with azacitidine is initiated the following month: azacitidine 75 mg/m² subcutaneously on Days 1-7 of each 28-day cycle for a total of 12 con
Standard consolidation chemotherapy with high-dose cytarabineDrug
Standard consolidation chemotherapy with high-dose cytarabine identical azacitidine maintenance therapy as experimental arm, no UCB infusion.
| Study group | Role | What they receive |
|---|---|---|
| Umbilical Cord Blood Consolidation Therapy | Experimental | Not described Receives: Biological: Unrelated Umbilical Cord Blood Infusion |
| Standard Cytarabine Consolidation Therapy | Active comparator | Not described Receives: Drug: Standard consolidation chemotherapy with high-dose cytarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Leukemia-Free Survival (LFS)
Time from initiation of study consolidation therapy until hematologic relapse, additional anti-leukemia salvage treatment initiation, or all-cause death within 2 years; proportion of participants without LFS events at 2 years. MRD defined negative by flow cytometry <0.1%.
Measured: Up to 24 months post randomization
Secondary outcomes (5)
2-Year Overall Survival (OS)
Proportion of participants alive from treatment initiation to 2 years; all-cause mortality counted as event.
Measured: Up to 24 months post randomization
MRD Negative Conversion Rate and Sustained MRD-Negative Duration
Percentage of subjects achieving MRD negative (<0.1%) during follow-up; continuous duration of sustained MRD negativity after first negative test.
Measured: Once monthly during the consolidation and maintenance treatment period, and once every three months during the first year after completion of maintenance treatment.
Median Time to Neutrophil and Platelet Recovery
Neutrophil recovery: first day of 3 consecutive days ANC >0.5×10⁹/L. Platelet recovery: first day of 3 consecutive days PLT>50×10⁹/L without transfusion support.
Measured: Baseline (Day 1) and up to 30 days of Consolidation Cycle 1 and Consolidation Cycle 2.
Treatment-Related Mortality (TRM) Rate
The proportion of participants who die as a result of treatment-related complications during the study period.
Measured: First 100 days after initial study consolidation
Incidence of Hematologic & Non-Hematologic Adverse Events
Frequency of Grade 1-5 toxicities assessed per CTCAE Version 5.0.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myelogenous Leukemia)Studies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junmin Li, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761702
- Sponsor's protocol ID
- 2026-UCB&AML
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized-Controlled Study of Cord Blood Consolidation Therapy for Intermediate- and High-Risk Elderly Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07761702
- Acronym / sponsor ID
- 2026-UCB&AML
- Conditions
- AML (Acute Myelogenous Leukemia)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute myeloid leukemia (AML) is a serious blood cancer that commonly affects older adults. Although patients may achieve complete remission after initial treatment, relapse remains common, especially in patients with intermediate- or adverse-risk disease.
This prospective, multicenter, randomized, open-label study will evaluate whether umbilical cord blood infusion used as consolidation therapy can improve outcomes in older patients with AML who have achieved complete remission after induction therapy. The study will enroll approximately 132 patients aged 60 to 80 years with newly diagnosed AML classified as intermediate or adverse risk according to the 2022 European LeukemiaNet criteria. Patients with acute promyelocytic leukemia, TP53 mutations, complex karyotypes, relapsed or refractory AML, or other conditions specified in the eligibility criteria will be excluded.
Participants will be randomly assigned in a 2:1 ratio to an experimental group or a control group. Participants in the experimental group will receive two cycles of consolidation treatment with decitabine, intermediate-dose cytarabine, and unrelated umbilical cord blood infusion. After completion of the two cord blood infusions, maintenance treatment with azacitidine will be recommended for up to 12 months. Participants in the control group will receive two cycles of standard consolidation chemotherapy with intermediate-dose cytarabine, followed by the same recommended azacitidine maintenance treatment.
Participants will be followed during maintenance treatment and for up to 2 years after consolidation therapy, or until disease progression, relapse, death, or another study endpoint occurs. The primary outcome is the proportion of participants who remain alive without leukemia relapse or additional anti-leukemia treatment at 2 years. Secondary outcomes include overall survival, conversion of measurable residual disease to negative status and duration of negativity, recovery of neutrophil and platelet counts, treatment-related mortality, and blood-related and non-blood-related toxicities. Exploratory outcomes include donor cell chimerism, immune status, and, where available, single-cell RNA sequencing or RNA sequencing results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Umbilical Cord Blood Consolidation Therapy | Experimental | Biological: Unrelated Umbilical Cord Blood Infusion |
| Standard Cytarabine Consolidation Therapy | Active comparator | Drug: Standard consolidation chemotherapy with high-dose cytarabine |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age between 60 and 80 years old, inclusive.
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unrelated Umbilical Cord Blood InfusionSubjects in the experimental arm receive consolidation chemotherapy with decitabine plus cytarabine, followed by unrelated cord blood infusion, then maintenance azacitidine after completion of two cord blood infusions. Decitabine is administered at 15 mg/m² per day intravenously on Days 1-5 of each consolidation cycle. Cytarabine 1.0 g/m² is given intravenously every 12 hours on Days 6-7 of each cycle. Unrelated umbilical cord blood (UCB) is infused on Day 9 of each consolidation cycle. UCB eligibility criteria: total nucleated cell (TNC) count >3×10⁷/kg pre-cryopreservation, HLA matching at 4/6 to 5/6 loci, ABO and Rh blood type compatibility preferred. The above consolidation regimen is repeated on Day 30 (counting Day 1 of decitabine as cycle Day 1), or earlier upon hematologic recovery. After completing two UCB infusions, maintenance therapy with azacitidine is initiated the following month: azacitidine 75 mg/m² subcutaneously on Days 1-7 of each 28-day cycle for a total of 12 con | Biological | Umbilical Cord Blood Consolidation Therapy |
| Standard consolidation chemotherapy with high-dose cytarabineStandard consolidation chemotherapy with high-dose cytarabine identical azacitidine maintenance therapy as experimental arm, no UCB infusion. | Drug | Standard Cytarabine Consolidation Therapy |
Primary outcome
2-Year Leukemia-Free Survival (LFS)
Time frame: Up to 24 months post randomization
Time from initiation of study consolidation therapy until hematologic relapse, additional anti-leukemia salvage treatment initiation, or all-cause death within 2 years; proportion of participants without LFS events at 2 years. MRD defined negative by flow cytometry <0.1%.
5 secondary outcomes
2-Year Overall Survival (OS)
Time frame: Up to 24 months post randomization
MRD Negative Conversion Rate and Sustained MRD-Negative Duration
Time frame: Once monthly during the consolidation and maintenance treatment period, and once every three months during the first year after completion of maintenance treatment.
Median Time to Neutrophil and Platelet Recovery
Time frame: Baseline (Day 1) and up to 30 days of Consolidation Cycle 1 and Consolidation Cycle 2.
Treatment-Related Mortality (TRM) Rate
Time frame: First 100 days after initial study consolidation
Incidence of Hematologic & Non-Hematologic Adverse Events
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Unrelated Umbilical Cord Blood Infusion and Standard consolidation chemotherapy with high-dose cytarabine in people with AML (Acute Myelogenous Leukemia), run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JunMin Li (86-21-64374756, drlijunmin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Year Leukemia-Free Survival (LFS) (time frame: Up to 24 months post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.