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

Nanfang Hospital, Southern Medical University

Status and phase

Completed

Phase 3

Phase 2

Conditions

Acute Myeloid Leukemia

Minimal Residual Disease

Treatments

Combination Product: MRD-directed therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT02870777

MRD directed therapy-AML-2016

Details and patient eligibility

About

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.

Enrollment

743 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Low-risk and intermediate-risk AML Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion criteria

Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) Patients with any conditions not suitable for the trial (investigators' decision)