NCT03417427

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Xuejie Jiang · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myeloid

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2018-02-01
• Primary completion: 2022-01-31
• Completion: 2025-01-31
• First posted: 2018-01-31
• Last updated: 2020-04-27

Locations

1 site across 1 country: China