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

Sponsor

Nanfang Hospital of Southern Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02936089

Collaborator

Zhujiang Hospital (Other)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia Risk Stratification	Drug: Ara-C Other: autologous HSCT Other: allogeneic HSCT	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Risk Stratification-directed Therapy for Acute Myeloid Leukemia With t(8;21) /AML1-ETO-positive

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Sep 1, 2019

Anticipated Study Completion Date :

Sep 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Risk Stratification-directed Therapy AE AML patients first received IA or DA induction therapy, and then received two courses of IDAC (Ara-C 1-2 g/m2 q12 h ×6 cycles). Subsequently, different subgroups of AE AML received different treatment based on risk stratification. For low-risk AE AML, they randomly received consolidation chemotherapy (two or three courses of IDAC) or autologous HSCT. For intermediate-risk AE AML, they randomly received consolidation chemotherapy (two or three courses of IDAC) or allogeneic HSCT. High-risk AE AML all received allogeneic HSCT.	Drug: Ara-C Ara-C was administered at 1-2 g/m2 q12 h ×6 cycles Other: autologous HSCT Other: allogeneic HSCT

Arm

Intervention/Treatment

Experimental: Risk Stratification-directed Therapy

AE AML patients first received IA or DA induction therapy, and then received two courses of IDAC (Ara-C 1-2 g/m2 q12 h ×6 cycles). Subsequently, different subgroups of AE AML received different treatment based on risk stratification. For low-risk AE AML, they randomly received consolidation chemotherapy (two or three courses of IDAC) or autologous HSCT. For intermediate-risk AE AML, they randomly received consolidation chemotherapy (two or three courses of IDAC) or allogeneic HSCT. High-risk AE AML all received allogeneic HSCT.

Drug: Ara-C

Ara-C was administered at 1-2 g/m2 q12 h ×6 cycles

Other: autologous HSCT

Other: allogeneic HSCT

Outcome Measures

Primary Outcome Measures

overall survival (OS) [3 year]

Secondary Outcome Measures

leukemia relapse rate [3 year]
disease-free survival (DFS) [3 year]
event Free Survival (EFS) [3 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

AE AML aged 15-60
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University
Zhujiang Hospital

Investigators

Principal Investigator: Dan Xu, Nanfang Hospital of Southern Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dan Xu, Professor, Nanfang Hospital of Southern Medical University

ClinicalTrials.gov Identifier:

NCT02936089

Other Study ID Numbers:

Risk stratification-AEAML-2016

First Posted:

Oct 18, 2016

Last Update Posted:

Oct 18, 2016

Last Verified:

Oct 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Oct 18, 2016