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
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.
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
11 years to 56 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.
|
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.
|
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.
|
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.
Collaborators
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
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