Risk Stratification-directed Therapy for AML With t(8;21) /AML1-ETO+

Not Applicable

Completed

• Conditions: Acute Myeloid Leukemia; Risk Stratification
• Interventions: Other: Consolidation with auto-HSCT or HLA-matched HSCT; Other: Consolidation with chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT); Other: allogeneic HSCT

• Registration Number: NCT02936089
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

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. For example, patients with c-kit mutation had higher relapse rate and lower overall survival, compared with those without c-kit mutation. Therefore, risk stratification-directed therapy is very necessary for AE AML. The purpose of this study is to establish risk stratification-directed therapy for AE AML.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-10-11
• Study First Submitted QC: 2016-10-14
• Study First Posted: 2016-10-18
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermediate risk group	Consolidation with auto-HSCT or HLA-matched HSCT	Patients with KIT+/ASXL1+ (single mutation, 1M) and acquiring MMR after two cycles of consolidation.
Low risk group	Consolidation with chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT)	Patients with KIT-ASXL1- (non-mutation, NM) and acquiring main molecular response (MMR) after two cycles of consolidation.
High risk group	allogeneic HSCT	Patients with KIT+ASXL1+ (two mutations ,2M) or without acquiring MMR after two cycles of consolidation.

Primary Outcome Measures

Name	Time	Method
overall survival (OS)	3 year

Secondary Outcome Measures

Name	Time	Method
event Free Survival (EFS)	3 year
leukemia relapse rate	3 year
disease-free survival (DFS)	3 year