A Clinical Trail of Demethylation Drug Combined With Chemotherapy in Intermediate-risk AML

Leukemia, Myeloid Clinical Trial

Official title:

A Multicenter Randomized Control Clinical Trail of Evaluating Effect of Demethylation Drug Combined With Chemotherapy in Patients With Intermediate-risk AML After Hematological Complete Remission

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03417427
• Other study ID #: LC2016YM005
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2018
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2020
• Source: Nanfang Hospital of Southern Medical University
• Contact: Xuejie Jiang, Doctor
• Phone: +8618688869522
• Email: jxj3331233[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is often impossible to find therapeutic target in intermediate-risk AML, so it is very important to select appropriate chemotherapy protocol to eliminate minimal residual disease (MRD) in these AML patients. Recent studies demonstrated that leukemia microenvironment is the shelter nich for leukemia stem cells and the essential reason for impossibly eliminating MRD. Demethylation drug not only prove the effect of chemotherapy, but also change leukemia microenvironment through epigenetics modification. Both of them will result in eliminating MRD in patients with AML. The investigators designed a multicenter randomized control clinical trail to evaluate the effect of demethylation drug combined with chemotherapy in AML patients with intermediate-risk factors after hematological complete remission. Efficacy will be evaluated through MRD detected by flow cytometry every 1 month. Continuous negative MRD indicates a good prognosis. The patients with continuous negative MRD can select auto-HSCT or consolidation chemotherapy, those with continuous positive MRD should be considered as candidates of allo-HSCT. Overall survival and relapse free survival will be recorded after follow-up every 3 months. It will provide a basis for precision therapy and a new way for designing a novel protocol for intermediate-risk AML. This clinical trail will benefit to the AML patients with intermediate-risk factors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

Inclusion Criteria:

• AML patients with normal heart, lung, liver and renal function, or without serious infection. ECOG score is below 2

Exclusion Criteria:

• AML patients with abnormal heart, lung, liver and renal function, or with serious infection. ECOG score is over 2

Related Conditions & MeSH terms

• Leukemia, Myeloid

Intervention

Drug:
• Decitabine and Ara-C
Decitabine in combination with high-dose of Ara-C is used to improve the effect of consolidation chemotherapy. It is expected to make minimal residual disease (MRD) become negative in more patients with intermediate-risk AML.
• Ara-C
Intermediate-risk AML patients with hematological complete remission and positive minimal residual disease (MRD) will receive high-dose of Ara-C (2g/m2 d4-6) consolidation chemotherapy.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Xuejie Jiang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimal residual disease	Minimal residual disease is detected by flow cytometry every 1 month in AML patients.	1 month
Secondary	Overall survival	AML patients are followed up every 3 months to evaluate overall survival	3 months
Secondary	Relapse free survival	AML patients are followed up every 3 months to evaluate relapse free survival.	3 months