Clinical trial · Interventional
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）
NCT06301425CI-TRIAL-00078694recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control group | Other | — | UNRESOLVED |
| Intervention group | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- According to the MFC MRD status after the first consolidation (MRDcon1), the MRDcon1 positive patients were categorized into high-risk group (i.e., risk stratification). All the patients in high-risk group who fulfilled all inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to receive a second consolidation therapy (intervention group) or receive allo-HSCT directly (control group).
- interventionNames
- Other: Intervention group
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- According to the MFC MRD status after the first consolidation (MRDcon1), the MRDcon1 positive patients were categorized into high-risk group (i.e., risk stratification). All the patients in high-risk group who fulfilled all inclusion/exclusion criteria were randomly assigned in a 1:1 ratio to receive a second consolidation therapy (intervention group) or receive allo-HSCT directly (control group).
- interventionNames
- Other: Control group
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.