MRD response-adapted treatment for high-risk acute myeloid leukemia
Measurable Residual Disease Response-adapted Allogeneic Hematopoietic Stem Cell Transplantation for Adverse-risk Acute Myeloid Leukemia: an Open-label, Randomized, Controlled Trial（TROPHY-AML01）
This study is testing a new way to treat high-risk acute myeloid leukemia by personalizing stem cell transplant plans based on how much leukemia is still detectable after initial treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 178 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06301425 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a regimen that adapts allogeneic hematopoietic stem cell transplantation (allo-HSCT) based on measurable residual disease (MRD) response in patients with adverse-risk acute myeloid leukemia (AML). The study is open-label and randomized, focusing on patients who have achieved complete remission after one or two courses of induction chemotherapy. Given the high relapse rates in this patient population, the trial aims to improve long-term leukemia-free survival by tailoring post-chemotherapy treatment based on MRD levels. The trial is conducted at multiple hospitals in China, including Peking University People's Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults aged 16-65 newly diagnosed with adverse-risk acute myeloid leukemia who achieve complete remission after one or two courses of chemotherapy.
Not a fit: Patients who are categorized as having favorable or intermediate-risk AML or those who do not achieve complete remission after induction chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and reduce relapse in patients with high-risk acute myeloid leukemia.
How similar studies have performed: Other studies have shown promise in using MRD as a predictor for relapse in AML, suggesting that this adaptive approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- Peking University People's Hospital — Beijing, China (Recruiting)
Study contacts
- Principal investigator: Xiaodong Mo — Peking University People's Hospital
- Study coordinator: Xiaodong Mo
- Email: moxiaodong@pkuph.edu.cn
- Phone: 86-10-88326001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.