Studies donor stem cell transplant in adults with newly diagnosed high-risk leukemia
Tests a donor stem cell transplant in adults with new high-risk AML.
Plain-language title generated from the registry record
Registry title: The Efficacy of Allo-HSCT in ND HR-CBF-AML
Key facts
- Where
- Shanghai, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 65 with newly diagnosed core-binding-factor acute myeloid leukemia (CBF-AML) at high risk of coming back. They get one cycle of induction and two cycles of consolidation chemotherapy, then a stem cell transplant from a donor.
- Age
- 18 to 65 years (18 years or older, younger than 65).
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed CBF-AML with a high risk of relapse: high-risk gene mutations, a complex karyotype, or a positive MRD test after two chemotherapy treatments. CBF-AML means the t(8;21) RUNX1-RUNX1T1 or the inv(16)/t(16;16) CBFβ-MYH11 change. Heart, liver and kidney function must be normal. ECOG score must be 0 to 2.
- Earlier treatment
- No chemotherapy before induction, except hydroxyurea. If white blood cells were 50*109/L or more at the start, cytarabine is also allowed before induction.
- Biomarker or test result
- The t(8;21)(q22;q22)/RUNX1-RUNX1T1 fusion gene, or inv(16)(p13.1q22)/t(16;16)(p13.1;q22) with the CBFβ-MYH11 fusion gene. Plus high-risk gene mutations (for example TP53, FLT3, NRAS, KRAS, KIT, ASXL1), a complex karyotype, or a positive MRD test (flow cytometry threshold 0.0001%).
Main reasons for not taking part
- AML that came from MDS or from earlier cancer treatment, or relapsed AML
- Leukemia in the central nervous system or outside the bone marrow at diagnosis
- Heart disease (EF below 50%, NYHA III/IV) or lung disease such as pulmonary edema or pleural effusion
- Another cancer at the same time, or active hepatitis A, B, C, tuberculosis, or HIV-positive
- Pregnant or breastfeeding women
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06458244, who can take part
Where in China
- Ruijin Hospital Affiliated to Shanghai Jiaotong University School of MedicineShanghai, ChinaContact: Jian Li, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Ruijin Hospital
- Trial code
- NCT06458244
- Record updated
- 16 April 2026
- Original description
For newly diagnosed high-relapse-risk core-binding-factor acute myeloid leukemia participants, the investigators aim to perform allogeneic hematopoietic stem cell transplantation after participants finished one cycle of induction and two cycles of consolidation. To access whether the therapeutic regimen is effective for high-relapse-risk core-binding-factor acute myeloid leukemia, the disease-free-survival (DFS), overall survival (OS), non-relapse-mortality of participants is evaluated.Read full original descriptionShow less
The Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation in Newly Diagnosed High-relapse-risk Core-binding-factor Acute Myeloid Leukemia
For newly diagnosed high-relapse-risk core-binding-factor acute myeloid leukemia participants, the investigators aim to perform allogeneic hematopoietic stem cell transplantation after participants finished one cycle of induction and two cycles of consolidation. To access whether the therapeutic regimen is effective for high-relapse-risk core-binding-factor acute myeloid leukemia, the disease-free-survival (DFS), overall survival (OS), non-relapse-mortality of participants is evaluated.
Inclusion: Participants with confirmed CBF-AML. Diagnostic criteria include the presence of t(8; 21)(q22; q22)/RUNX1-RUNX1T1 fusion gene detected at the molecular level; or chromosome presence of inv(16)(p13.1q22)/t(16; 16)(p13.1; q22) /Detection of CBFβ-MYH11 fusion gene at the molecular level; Participants with high-risk gene mutations or complex karyotypes for disease recurrence, or flow cytometry/gene MRD positivity after two chemotherapy treatments; High-risk gene mutations include: TP53, RTK/RAS signaling (FLT3, NRAS, KRAS, KIT, JAK2, CSF3R), chromatin modification (ASXL1, ASXL2, KMD6A, EZH2, SETD2) or mutations listed as intermediate-risk or high-risk in the 2022NCCN guidelines; The positive threshold for flow cytometry MRD was 0.0001%; The MRD threshold of molecular biology is the lowest value of the detection protocol of the center; Medical history and diagnosis of MICM, exclusion of MDS, transformation and treatment-related AML; Age 18-65 years old (18 years old ≤Age< 65 years old); Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal, serum creatinine ≤ 150 μmol/L; Normal cardiac function (EF≥50%, New York Cardiac Function Classification NYHA I/II); Physical condition score 0-2 (ECOG score); For participants with peripheral blood leukocytes < 50*109/L at the initial onset, no chemotherapy has been given except for hydroxyurea before the start of induction therapy; For participants with peripheral blood leukocytes ≥ 50*109/L at the initial onset, cytarabine and hydroxyurea are allowed to be treated before the start of induction therapy; Non-pregnant and lactating women; For all women of childbearing age, a pregnancy test must be performed to measure hCG to rule out pregnancy; Obtain informed consent signed by the patient or family member.
Exclusion: Concomitant other hematologic diseases (including coagulation abnormalities unrelated to leukemia); Allergies or contraindications to any of the drugs involved in the protocol; Lung diseases: pulmonary edema, pleural effusion (CTCAE score >2); Suffering from malignant tumors of other organs at the same time; Active patients with HAV, HBV, HCV and tuberculosis, HIV-positive patients; Those who participate in other clinical studies at the same time; Presence of any other condition that would preclude the conduct of the study; Cardiac disease: including echocardiogram EF <50%, cardiac insufficiency (New York cardiac function classification NYHA: III/IV), pericardial effusion (CTCAE score >2) within six months after acute myocardial infarction, ECG QTc >470ms; MDS-converted AML, treatment-related AML; mixed cell leukemia; AML with central nervous system infiltrates and extramedullary lesions at the time of onset; Relapse AML; Liver and kidney function are obviously abnormal, exceeding the enrollment criteria; Inability to understand or follow the study protocol.