Efficacy of Decitabine in Clearance of MRD

NCT ID: NCT03021395

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-08
• Study Completion Date: 2022-12-31

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.

Conditions

AML

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MRD-positive

MRD-positive patients receive Decitabine regimen.

Group Type: EXPERIMENTAL

Decitabine

Intervention Type: DRUG

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

MRD-negative

MRD-negative patients receive no intervention.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Decitabine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianxiang Wang, Dr

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, China

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Other Identifiers

IIT2016007（Decitabine）

Identifier Type: -

Identifier Source: org_study_id