NCT06301425 MRD Response-adapted Allo-HSCT for Adverse-risk AML
| NCT ID | NCT06301425 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 178 participants |
| Start Date | 2024-05-24 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 178 participants in total. It began in 2024-05-24 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Xiaodong Mo
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT06301425 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 65 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06301425 currently recruiting?
Yes, NCT06301425 is actively recruiting participants. Contact the research team at moxiaodong@pkuph.edu.cn for enrollment information.
Where is the NCT06301425 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06301425 clinical trial?
NCT06301425 is sponsored by Peking University People's Hospital. The principal investigator is Xiaodong Mo at Peking University People's Hospital. The trial plans to enroll 178 participants.
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