NCT03417427

Brief Summary

It is often impossible to find therapeutic target in intermediate-risk AML, so it is very important to select appropriate chemotherapy protocol to eliminate minimal residual disease (MRD) in these AML patients. Recent studies demonstrated that leukemia microenvironment is the shelter nich for leukemia stem cells and the essential reason for impossibly eliminating MRD. Demethylation drug not only prove the effect of chemotherapy, but also change leukemia microenvironment through epigenetics modification. Both of them will result in eliminating MRD in patients with AML. The investigators designed a multicenter randomized control clinical trail to evaluate the effect of demethylation drug combined with chemotherapy in AML patients with intermediate-risk factors after hematological complete remission. Efficacy will be evaluated through MRD detected by flow cytometry every 1 month. Continuous negative MRD indicates a good prognosis. The patients with continuous negative MRD can select auto-HSCT or consolidation chemotherapy, those with continuous positive MRD should be considered as candidates of allo-HSCT. Overall survival and relapse free survival will be recorded after follow-up every 3 months. It will provide a basis for precision therapy and a new way for designing a novel protocol for intermediate-risk AML. This clinical trail will benefit to the AML patients with intermediate-risk factors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

4 years

First QC Date

May 13, 2017

Last Update Submit

April 24, 2020

Conditions

Leukemia, Myeloid

Keywords

acute myeloid leukemiaIntermediate-riskdemethylation drugcomplete remission

Outcome Measures

Primary Outcomes (1)

  • Minimal residual disease

    Minimal residual disease is detected by flow cytometry every 1 month in AML patients.

    1 month

Secondary Outcomes (2)

  • Overall survival

    3 months

  • Relapse free survival

    3 months

Study Arms (2)

Decitabine and Ara-C

ACTIVE COMPARATOR

Intermediate-risk AML patients with hematological complete remission and positive minimal residual disease (MRD) will receive decitabine (15mg/m2 d1-5) combined with high-dose of Ara-C (2g/m2 d4-6) consolidation chemotherapy.

Drug: Decitabine and Ara-C

Ara-C

PLACEBO COMPARATOR

Intermediate-risk AML patients with hematological complete remission and positive minimal residual disease (MRD) will receive high-dose of Ara-C (2g/m2 d4-6) consolidation chemotherapy.

Drug: Ara-C

Interventions

Decitabine and Ara-CDRUG

Decitabine in combination with high-dose of Ara-C is used to improve the effect of consolidation chemotherapy. It is expected to make minimal residual disease (MRD) become negative in more patients with intermediate-risk AML.

Also known as: Decitabine in combination with high-dose of Ara-C
Decitabine and Ara-C
Ara-CDRUG

Intermediate-risk AML patients with hematological complete remission and positive minimal residual disease (MRD) will receive high-dose of Ara-C (2g/m2 d4-6) consolidation chemotherapy.

Also known as: High-dose of Ara-C
Ara-C

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • AML patients with normal heart, lung, liver and renal function, or without serious infection. ECOG score is below 2

You may not qualify if:

  • AML patients with abnormal heart, lung, liver and renal function, or with serious infection. ECOG score is over 2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guanzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

Leukemia, MyeloidLeukemia, Myeloid, AcutePathologic Complete Response

Interventions

DecitabineCytarabine

Condition Hierarchy (Ancestors)

LeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesArabinonucleosides

Central Study Contacts

Xuejie Jiang, Doctor

CONTACT

+8618688869522jxj3331233@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 13, 2017

First Posted

January 31, 2018

Study Start

February 1, 2018

Primary Completion

January 31, 2022

Study Completion

January 31, 2025

Last Updated

April 27, 2020

Record last verified: 2020-04

Locations

CN(1)