Clinical trial · Observational
Risk-stratified Therapy Based on Molecular Cytogenetic Aberration and Treatment Response in AML
Risk-stratified Therapy Based on Molecular and Cytogenetic Aberration and Treatment Response in Acute Myeloid Leukemia
- 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)
Risk-stratified therapy based on molecular and cytogenetic for acute myeloid leukemia (AML) is well accepted and benefits patients' survival. However, neither every patient with low risk factors obtains better survival, nor all high risk patients experience worse outcome. Lots of data have shown that the early treatment response presenting as minimal residual disease (MRD) has an important role in prognostic prediction. In this study, we perform risk stratification based on not only Cytogenetic and Molecular characteristic, but also MRD after three courses of chemo therapy in AML cohort. Patients with MRD positive would be moved to a higher risk class. And then the risk-stratified therapy should be considered according to the new risk stratification.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cytogenetic Abnormality | — | UNRESOLVED | — |
| Molecular Abnormality | — | UNRESOLVED | — |
| MRD | — | UNRESOLVED | — |
| Risk-directed Therapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Justified risk stratification based on MRD after three course chemo therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Risk stratification
- description
- Risk stratification based on cytogenetic and molecular and MRD level after three courses of chemo therapy.
- interventionNames
- Other: Justified risk stratification based on MRD after three course chemo therapy
Primary outcomes (1)
- measure
- relapse rate
- timeFrame
- 2 year
Secondary outcomes (2)
- measure
- overall survival (OS)
- timeFrame
- 2 year
- measure
- disease-free survival (DFS)
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: All newly diagnosed AML exclusively of APL with age range from 14 to 60-year old Exclusion Criteria: Any abnormality in a vital sign (e.g., organ function failure, serious infection ) Patients with any conditions not suitable for the trial (investigators' decision)
References
Publications (2)
- DERIVEDYu S, Liu H, Zhao W, Yu G, Shi P, Nie D, Sun Z, Liu Q, Shao R, Feng Z, Liang X, Zhang X, Du X, Xu X, Wang S, Zhang Q, Jiang Y, Zhang H, Guo Z, Dai M, Jiang X, Xu D, Huang F, Fan Z, Xu N, Liu Q, Liang Q, Liu C, Wu M, Weng G, Lin R, Jin H, Sun J, Wang Y, Xuan L, Zhang Y, Liu Q. Autologous transplant versus matched sibling donor transplant in intermediate-risk AML in CR1 with no detectable MRD: a biological assignment comparative study. Exp Hematol Oncol. 2026 Jul 6;15(1):67. doi: 10.1186/s40164-026-00807-y. PMID 42410464
- DERIVEDZhang Y, Feng Z, Du J, Liu H, Yu S, Liang X, Zhao W, Zhang Q, Zhang X, Nie D, Sun Z, Du X, Xu X, Yu G, Shi P, Liu Q, Shao R, Qu H, Xiong W, Wang S, Jiang Y, Zhang H, Guo Z, Dai M, Jiang X, Xu D, Huang F, Fan Z, Xu N, Liu C, Wu M, Lin R, Jin H, Sun J, Liu Q, Xuan L. High-dose cytarabine with idarubicin consolidation for acute myeloid leukemia in first complete remission: a randomized controlled trial. Leukemia. 2025 Aug;39(8):1857-1864. doi: 10.1038/s41375-025-02655-x. Epub 2025 May 28. PMID 40437173