Intervention group: Patients in interventional group could choose one of the following treatment protocols and then receive allo-HSCT if they were CR after the second consolidation:
1. . Venetoclax plus azacitidine: azacitidine 75mg/m2/d d1-7; venetoclax 400mg/d, d1-21;
2. . Venetoclax plus CAG: venetoclax 400mg qd d1-14; aclacinomycin 20mg qd d1-4; cytarabine 10mg/m2 q12h subcutaneous injection d1-14; G-CSF 300μg qd d1-14;
3. . Venetoclax plus IA: venetoclax 400mg qd d1-4; idarubicin 10mg qd d1-4; cytarabine 500mg qd d1-4;
4. . Venetoclax plus AA: venetoclax 400mg qd d1-7; aclacinomycin 20mg qd d1-7; cytarabine 100mg/m2 qd d1-7.
Control group: Receive allo-HSCT directly without the second consolidation chemotherapy.
Study summary
This TROPHY-AML01 regimen aims to identify the effectiveness and safety of MRD response-adapted allo-HSCT for adverse-risk acute myeloid leukemia in an open-label, randomized, controlled trial.
Eligibility
Sex
ALL
Min age
16 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Newly diagnosed AML;
2. Categorized into adverse-risk group according to ELN 2022 criteria;
3. 16-65 years of age at the time of diagnosis;
4. achieving CR after 1 or 2 courses of induction chemotherapies;
4\) ECOG PS score of 0 to 1 5) It needs consent from the patients or/and legal guardian, and signature on the Informed Consent.
Exclusion Criteria:
1. Newly diagnosed AML, but categorized into favorite- or intermediate-risk group according to ELN 2022 criteria;
2. \< 16 years, or older than 65 years at the time of diagnosis;
3. Achieving CR after 3 or more courses of induction chemotherapies, or could not achieve CR after induction chemotherapies;
4. ECOG PS score of 2 or more;
5. Patients with other comorbidities or mental diseases that influence the life safety and compliance of patients as well as affect informed consent, enrollment in the research, follow-up visit or result interpretation.
Primary outcome measure(s)
Event-free survival (EFS) — 1 year EFS, defined as the time from the date of randomization to the date of MRD positivity, relapse, or death due to any cause.
Trial sites (1)
Facility
City
Region
Status
Peking University People's Hospital
Beijing
China
Recruiting
More Peking University People's Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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