NCT02870777

MRD-directed Therapy for Low-risk and Intermediate-risk AML.

Minimal Residual Disease-directed Therapy for Low-risk and Intermediate-risk Acute Myeloid Leukemia.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 743 (actual)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Acute myeloid leukemia(AML) patients with favorable and intermediate cytogenetics at diagnosis are generally excluded from first-line allo-SCT. However, these patients may eventually relapse in some cases. Our previous study found that stratification of treatment based on cytogenetics and therapeutic response could benefit low and intermediate AML. To further verify the results, we conducted a prospective multi-center study. The purpose of this study is to establish risk stratification based on cytogenetics and minimal-residual-disease (MRD) analysis to determine whether a MRD-directed therapy for low and intermediate AML patients has positive results in terms of overall survival.

Conditions

• Acute Myeloid Leukemia
• Minimal Residual Disease

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MRD-directed therapy	The purpose of this study is to establish risk stratification based on cytogenetics at diagnosis and MRD analysis after induction chemotherapy and before consolidation chemotherapy to determine whether a MRD directed therapy for low and intermediate AML patients has positive results in terms of overall survival.

Timeline

• Start date: 2016-08-01
• Primary completion: 2019-08-31
• Completion: 2019-12-31
• First posted: 2016-08-17
• Last updated: 2020-03-04

Locations

1 site across 1 country: China