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

August 6, 2023 updated by: Nanfang Hospital, Southern Medical University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

207

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 58 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low risk group
Patients with KIT-ASXL1- (non-mutation, NM) and acquiring main molecular response (MMR) after two cycles of consolidation.
Other: 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.
Experimental: Intermediate risk group
Patients with KIT+/ASXL1+ (single mutation, 1M) and acquiring MMR after two cycles of consolidation.
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.
Experimental: High risk group
Patients with KIT+ASXL1+ (two mutations ,2M) or without acquiring MMR after two cycles of consolidation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival (OS)
Time Frame: 3 year
3 year

Secondary Outcome Measures

Outcome Measure
Time Frame
leukemia relapse rate
Time Frame: 3 year
3 year
disease-free survival (DFS)
Time Frame: 3 year
3 year
event Free Survival (EFS)
Time Frame: 3 year
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

Zhujiang Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

October 11, 2016

First Submitted That Met QC Criteria

October 14, 2016

First Posted (Estimated)

October 18, 2016

Study Record Updates

Last Update Posted (Actual)

August 8, 2023

Last Update Submitted That Met QC Criteria

August 6, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2017-168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected IPD, all IPD that underlie results will be shared in a publication. For the detail, those who are interested in can contact the authors.

IPD Sharing Time Frame

The data will be available after being published, for at least five years.

IPD Sharing Access Criteria

All collected IPD, all IPD that underlie results will be shared in a publication. For the detail, those who are interested in can contact the authors.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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