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

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: Risk Stratification; Acute Myeloid Leukemia

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT02936089

NFEC-2017-168

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 3 patient groups

Low risk group

Experimental group

Description:

Patients with KIT-ASXL1- (non-mutation, NM) and acquiring main molecular response (MMR) after two cycles of consolidation.

Treatment:

Other: Consolidation with chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT)

Intermediate risk group

Experimental group

Description:

Patients with KIT+/ASXL1+ (single mutation, 1M) and acquiring MMR after two cycles of consolidation.

Treatment:

Other: Consolidation with auto-HSCT or HLA-matched HSCT

High risk group

Experimental group

Description:

Patients with KIT+ASXL1+ (two mutations ,2M) or without acquiring MMR after two cycles of consolidation.

Treatment:

Other: allogeneic HSCT