Efficacy of Decitabine in Clearance of MRD | NCT03021395

Studies
Efficacy of Decitabine in Clearance of MRD

NCT03021395

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Status

Withdrawn

Last Update Posted

May 30, 2025Actual

Enrollment

0Actual

Phase

Phase 1Phase 2

Conditions

Interventions

Decitabine

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No participants enrolled

Expanded Access Info

Start Date

Feb 8, 2017Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

Jan 12, 2017

First Submission Date that Met QC Criteria

Jan 12, 2017

First Posted Date

Jan 13, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2025

Last Update Posted Date

May 30, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In this open-label, prospective clinical trial, acute myeloid leukemia (AML) patients after consolidation therapy are enrolled. Patients with minimal residual disease (MRD) after consolidation therapy receive decitabine treatment if patients do not receive stem cell transplantation. The treatment regimen includes three course of decitabine regimen at a dose of 20mg/m² on day1-5. The MRD clearance rate is the primary outcome to measure the efficacy of decitabine regimen.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MRD-positive	Experimental	MRD-positive patients receive Decitabine regimen.	Drug: Decitabine
MRD-negative	No Intervention	MRD-negative patients receive no intervention.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Decitabine	Drug	Decitabine at a dose of 20mg/㎡/d on day 1-5.	MRD-positive

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Non-relapse Mortality		Within 5 years after treatment
Overall Survival Rate (OS)		Within 5 years after treatment
Cumulative incidence of relapse

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

55 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001374	Azacitidine
D001372	Aza Compounds
D009930	Organic Chemicals
D003562	Cytidine