Clinical trial · Interventional
Risk Stratification-directed Therapy for AML With t(8;21) /AML1-ETO+
Risk Stratification-directed Therapy for Acute Myeloid Leukemia With t(8;21) /AML1-ETO-positive
NCT02936089CI-TRIAL-00068646completedN/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)
Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease entailing different prognoses. There were significant differences in the therapeutic effect between different subgroups of AE AML. Therefore, risk stratification-directed therapy is very necessary for AE AML.
Conditions
Conditions (2)
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 |
| Risk Stratification | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| allogeneic HSCT | Other | — | UNRESOLVED |
| Consolidation with auto-HSCT or HLA-matched HSCT | Other | — | UNRESOLVED |
| Consolidation with chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Low risk group
- description
- Patients with KIT-ASXL1- (non-mutation, NM) and acquiring main molecular response (MMR) after two cycles of consolidation.
- interventionNames
- Other: Consolidation with chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT)
- type
- EXPERIMENTAL
- label
- Intermediate risk group
- description
- Patients with KIT+/ASXL1+ (single mutation, 1M) and acquiring MMR after two cycles of consolidation.
- interventionNames
- Other: Consolidation with auto-HSCT or HLA-matched HSCT
- type
- EXPERIMENTAL
- label
- High risk group
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * AE AML aged 14-70 * No abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Expected survival time is more than 2 months Exclusion Criteria: * Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
References
Publications (1)
- DERIVEDXu D, Yang Y, Yin Z, Tu S, Nie D, Li Y, Huang Z, Sun Q, Huang C, Nie X, Yao Z, Shi P, Zhang Y, Jiang X, Liu Q, Yu G. Risk-directed therapy based on genetics and MRD improves the outcomes of AML1-ETO-positive AML patients, a multi-center prospective cohort study. Blood Cancer J. 2023 Nov 13;13(1):168. doi: 10.1038/s41408-023-00941-4. No abstract available. PMID 37957175