MRD Response-adapted Allo-HSCT for Adverse-risk AML

Recruiting now · Not applicable

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT06301425

Run by

Peking University People's Hospital

People needed

178

Starts

2024-05-24

Expected to finish

2028-05-01

Last updated by the study team

2024-07-10

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Newly diagnosed AML;
• Categorized into adverse-risk group according to ELN 2022 criteria;
• 16-65 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.

You may not qualify if…

• 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.

Where it is running

• Peking University People's Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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