NCT07131059

MRD-positive AML Clinical Study

MRD-positive AML: a Prospective, Single-arm, Multicenter Platform Clinical Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is a platform-type clinical study intended to investigate the efficacy and safety of MRD-positive acute myeloid leukemia patients after comprehensive treatment, which includes but is not limited to the following drugs and protocols: Chemotherapy, small molecule targeted drugs, demethylation drugs, liposome drugs and the combination of these drugs to form a combination of treatment regimen, the specific treatment regimen will be updated according to the results of this trial and the latest research progress at home and abroad.

Detailed description

Patients aged 14 years or older with diagnosed AML (non-M3) who have achieved complete remission in bone marrow morphology but are positive for minimal residual disease by flow cytometry or have the following genetic mutations that can be detected by PCR: NPM1 mutation, IDH1/2 mutation, DEK-NUP214 (DEK-CAN), RUNX1-RUNX1T1(AML 1-ETO), or CBFβ-MYH 11\[4\]. NGS can detect mutations such as FLT3. For eligible patients, the treatment plan is selected by the doctor in charge according to the specific conditions of the patient. During the treatment, patients can have hematopoietic stem cell transplantation at any time. This study compared relapse-free survival and overall survival of MRD-positive patients after effective and persistent MRD treatment, and based on the results, observed the efficacy and safety of different treatment regiments for MRD-positive AML patients.

Conditions

• AML, Adult

Interventions

Type	Name	Description
DRUG	Ivosidenib	500mg d1-28
DRUG	Gilteritinib	120mg d1-28
DRUG	Venetoclax	400mg d1-21 ; 400mg d1-7;400mg d1-28; 600mg d1-21
DRUG	Avapritinib	200mg d1-28.
DRUG	Daunorubicin	45mg/m2/d d1-2;
DRUG	Cytarabine	100mg/m2/d d1-5
DRUG	Idarubicin	10mg/m2/d d1-2
DRUG	MTZ	8mg/m2/d d1-2
DRUG	HHT	2mg/m2/d d1-5
DRUG	Azacitidine	75mgd/m2 d1-7.

Timeline

• Start date: 2024-05-11
• Primary completion: 2026-05-10
• Completion: 2028-04-30
• First posted: 2025-08-20
• Last updated: 2025-08-20

Locations

1 site across 1 country: China