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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia Risk Stratification

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patients with newly diagnosed AML1/ETO-positive AML took risk-directed stratification therapy based on c-KIT and ASXL1 mutations and measurable residual disease (MRD). low risk (LR) group (KIT-ASXL1- with main molecular response (MMR)) was recommended to chemotherapy (CT) or autologous hematopoietic stem cell transplantation (auto-HSCT). Intermediate risk (IR) group (KIT+/ASXL1+ with MMR) was suggested for auto-HSCT or HLA-matched HSCT. High risk (HR) group (KIT+ASXL1+ or without MMR) was treated with allogeneic (allo-) HSCT.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low risk group

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

Group Type EXPERIMENTAL

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

Intervention Type OTHER

For CT, patients were treated with high dose cytarabine (HDAC), cytarabine at a dosage of 1-3 g/m2 q12 h ×6 doses, for 4-6 cycles.

For auto-HSCT, patients were treated with 3 cycles of HDAC and then bridged to auto-HSCT.

Intermediate risk group

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

Group Type EXPERIMENTAL

Consolidation with auto-HSCT or HLA-matched HSCT

Intervention Type OTHER

For auto-HSCT, patients were treated with 3 cycles of HDAC and then bridged to auto-HSCT.

For HLA-matched HSCT, patients were treated with 1-2 cycles of HDAC and then bridged to HLA-matched HSCT. HLA-matched donors were available in these patients.

High risk group

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

Group Type EXPERIMENTAL

allogeneic HSCT

Intervention Type OTHER

For allogeneic HSCT, patients were treated with 1-2 cycles of HDAC and then bridged to allogeneic HSCT, including HLA-matched and haploidentical transplantation.

Interventions

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

For CT, patients were treated with high dose cytarabine (HDAC), cytarabine at a dosage of 1-3 g/m2 q12 h ×6 doses, for 4-6 cycles.

For auto-HSCT, patients were treated with 3 cycles of HDAC and then bridged to auto-HSCT.

Intervention Type OTHER

Consolidation with auto-HSCT or HLA-matched HSCT

For auto-HSCT, patients were treated with 3 cycles of HDAC and then bridged to auto-HSCT.

For HLA-matched HSCT, patients were treated with 1-2 cycles of HDAC and then bridged to HLA-matched HSCT. HLA-matched donors were available in these patients.

Intervention Type OTHER

allogeneic HSCT

For allogeneic HSCT, patients were treated with 1-2 cycles of HDAC and then bridged to allogeneic HSCT, including HLA-matched and haploidentical transplantation.

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

14 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No