NCT03021395

Brief Summary

In this open-label, prospective clinical trial, the investigators enrolled acute myeloid leukemia (AML) patients after consolidation therapy. Patients with minimal residual disease (MRD) receive decitabine treatment if patients do not receive stem cell transplantation. The MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2017

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

February 8, 2017

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

May 30, 2025

Status Verified

March 1, 2019

Enrollment Period

4.8 years

First QC Date

January 12, 2017

Last Update Submit

May 26, 2025

Conditions

AML

Outcome Measures

Primary Outcomes (1)

  • MRD Clearance Rate

    MRD Clearance Rate is defined as the ratio patients that transform from MRD-positive to MRD-negative after treatment in all of the MRD-positive patients.

    Within 6 months after decitabine treatment

Secondary Outcomes (3)

  • Non-relapse Mortality

    Within 5 years after treatment

  • Overall Survival Rate (OS)

    Within 5 years after treatment

  • Cumulative incidence of relapse

    Within 5 years after treatment

Study Arms (2)

MRD-positive

EXPERIMENTAL

MRD-positive patients receive Decitabine regimen.

Drug: Decitabine

MRD-negative

NO INTERVENTION

MRD-negative patients receive no intervention.

Interventions

DecitabineDRUG

Decitabine at a dose of 20mg/㎡/d on day 1-5.

MRD-positive

Eligibility Criteria

Age14 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age of 14 to 55 years old;
  • Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML after consolidation regimen.
  • Patients who had received induction and consolation therapy and reached CR.
  • ECOG score of ≤ 2;
  • Patients with eligible laboratory examination including liver,renal and heart function.
  • Adult patients are willing to participate in the study and sign the informed consent by themselves or by their immediate family. Patients under 18 years old willing to participate should have their legal guardians sign the informed consent.

You may not qualify if:

  • Secondary leukemia.
  • Patients had other tumor at active stage or had received radiotherapy or chemotherapy in the last 6 months due to other tumor.
  • Patients with other blood diseases(for example, haemophiliacs) are excluded.However, undiagnosed MDS or MPD patients are included.
  • Acute panmyelosis with myelofibrosis and myeloid sarcoma patients;
  • With BCR-ABL fusion gene;
  • Pregnant or lactating women;
  • With ineligible renal or liver function;
  • With active cardiovascular disease;
  • Severe infection disease including uncured tuberculosis pulmonary aspergillosis;
  • AIDS;
  • Patients had central nervous system involvement when they were diagnosed as AML.
  • Patients with epilepsy or dementia or other mental disease who couldn't understand or follow the research.
  • Drugs, medical, mental or social situation may distract patients from following the research or being evaluated the results.
  • Patients with other factors which were considered unsuitable to participate in the study by the investigators.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Interventions

Decitabine

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Jianxiang Wang, Dr

    Institute of Hematology & Blood Diseases Hospital, China

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 13, 2017

Study Start

February 8, 2017

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

May 30, 2025

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)