Efficacy of Decitabine in Clearance of MRD

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.

Study Overview

• Status: Withdrawn
• Conditions: AML
• Intervention / Treatment: Drug: Decitabine

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Institute of Hematology & Blood Diseases Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age of 14 to 55 years old;
2. Patients that meet the diagnostic criteria(WHO 2008 criteria) of AML after consolidation regimen.
3. Patients who had received induction and consolation therapy and reached CR.
4. ECOG score of ≤ 2;
5. Patients with eligible laboratory examination including liver,renal and heart function.
6. 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:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MRD-positive; MRD-positive patients receive Decitabine regimen.	Drug: Decitabine; Decitabine at a dose of 20mg/㎡/d on day 1-5.
No Intervention: MRD-negative; MRD-negative patients receive no intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China
• Investigators: Principal Investigator: Jianxiang Wang, Dr, Institute of Hematology & Blood Diseases Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2017
• Primary Completion (Estimated): December 1, 2021
• Study Completion (Estimated): December 1, 2022

Study Registration Dates

• First Submitted: January 12, 2017
• First Submitted That Met QC Criteria: January 12, 2017
• First Posted (Estimated): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 26, 2025
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Decitabine
• Other Study ID Numbers: IIT2016007（Decitabine）

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No