Actively Recruiting
MRD-positive AML: Prospective, Single-arm, Multicenter Platform Clinical Study
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-20
120
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients aged 14 and older with acute myeloid leukemia (AML) who have achieved complete remission but still show minimal residual disease (MRD) by specific tests or have certain genetic mutations. This study aims to investigate the safety and effectiveness of various treatment regimens for MRD-positive AML patients, including chemotherapy, targeted drugs, and combinations, adjusting regimens based on study findings and latest research. Patients receive different drug combinations selected by their doctor based on individual conditions. Treatments include drugs like Ivosidenib, Gilteritinib, Venetoclax, Avapritinib, Daunorubicin, Cytarabine, Idarubicin, MTZ, HHT, and Azacitidine with various dosing schedules over 28-day cycles. Hematopoietic stem cell transplantation can be performed at any time during treatment. The study uses a randomized design to compare relapse-free survival and overall survival among MRD-positive patients after treatment. Participants undergo monitoring for relapse-free survival up to 6 months and overall survival from enrollment until death. Other assessments include MRD levels, the proportion of patients turning MRD negative, cumulative relapse rates, and adverse events including serious infections over up to 2 years. The study involves regular evaluations to track treatment effects and safety over this period, contributing to understanding which treatments best manage MRD-positive AML.
CONDITIONS
Brief Title
MRD-positive AML Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with AML (non-M3) according to WHO (2016) standards
- In complete remission based on bone marrow morphology
- Positive for minimal residual disease by flow cytometry or PCR detection of specific mutations (NPM1, RUNX1-RUNX1T1, CBFB-MYH11, DEK-NUP214) or NGS detection of FLT3 mutation
- Age 14 years or older
- Male or female
- Signed informed consent by patient, legal guardian, or immediate family member prior to study procedures
You will not qualify if you...
- Planning to undergo hematopoietic stem cell transplantation within 4 weeks
- Diagnosis of acute promyelocytic leukemia (APL)
- Deemed unsuitable for inclusion by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive one of several drug regimens selected by their doctor based on their specific AML genetic mutations or condition. Treatments include drugs such as Ivosidenib, Gilteritinib, Venetoclax, Avapritinib, Daunorubicin, Cytarabine, Idarubicin, MTZ, HHT, and Azacitidine with varying dosing schedules over 28-day cycles.
Weekly visits for up to 6 months
Duration - Up to 2 years
Participants are monitored for relapse-free survival, overall survival, measurable residual disease, and adverse events after completing treatment.
Periodic visits depending on participant status
Trial Site Locations
Total: 1 location
1
Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
H
Hui Wei, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
FACTORIAL
Primary Purpose
TREATMENT
Number of Arms
7
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