Efficacy of Decitabine in Clearance of MRD

AML Clinical Trial

Official title:

Efficacy of Decitabine in Clearance of MRD

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03021395
• Other study ID #: IIT2016007-EC-1-4
• Status: Suspended
• Phase: Phase 1/Phase 2
• Start date: February 8, 2017
• Est. completion date: December 2022

Study information

• Verified date: March 2019
• Source: Institute of Hematology & Blood Diseases Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 300
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• AML

Intervention

Drug:
• Decitabine
Decitabine at a dose of 20mg/?/d on day 1-5.

Locations

Country	Name	City	State
China	Institute of Hematology & Blood Diseases Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Non-relapse Mortality		Within 5 years after treatment
Secondary	Overall Survival Rate (OS)		Within 5 years after treatment
Secondary	Cumulative incidence of relapse		Within 5 years after treatment