NCT06301425Recruiting
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）
Source: ClinicalTrials.gov · Last updated 10 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 178 (estimated)
- First submitted
- 2 Mar 2024
- Start date
- 24 May 2024
- Primary completion date
- 1 May 2027
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Acute myeloid leukemia, Childhood cancers
- NCT number
- NCT06301425
What you commit to
- Study type: Interventional
- Planned participants: 178
- From 24 May 2024 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Age
- \< 16 years, or older than 65 years at the time of diagnosis;
Other
- Newly diagnosed AML, but categorized into favorite- or intermediate-risk group according to ELN 2022 criteria;
- 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;
Who the study is looking for
- 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;
- 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.
Age in the registry: 16 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.