MRD Response-adapted Allo-HSCT for Adverse-risk AML
Measurable Residual Disease Response-adapted Allogeneic Hematopoietic Stem Cell Transplantation for Adverse-risk Acute Myeloid Leukemia: an Open-label, Randomized, Controlled Trial（TROPHY-AML01）
Peking University People's Hospital
178 participants
May 24, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Newly diagnosed AML;
- Categorized into adverse-risk group according to ELN 2022 criteria;
- years of age at the time of diagnosis;
- achieving CR after 1 or 2 courses of induction chemotherapies;
- \) 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 Criteria5
- Newly diagnosed AML, but categorized into favorite- or intermediate-risk group according to ELN 2022 criteria;
- \< 16 years, or older than 65 years at the time of diagnosis;
- Achieving CR after 3 or more courses of induction chemotherapies, or could not achieve CR after induction chemotherapies;
- ECOG PS score of 2 or more;
- 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.
Interventions
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.
Receive allo-HSCT directly without the second consolidation chemotherapy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06301425