MRD-positive AML Clinical Study

Institute of Hematology & Blood Diseases Hospital, China120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

AML, Adult

Interventions

IvosidenibDRUG

500mg d1-28

GilteritinibDRUG

120mg d1-28

VenetoclaxDRUG

400mg d1-21 ; 400mg d1-7;400mg d1-28; 600mg d1-21

Avapritinib

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

Inclusion Criteria: * AML (non-M3) compliant with WHO (2016) standards; * In morphological complete remission. * Mrd-positive patients: including bone marrow flow cytometry, PCR quantification of NPM1 mutations, PCR quantification of fusion genes (RUNX 1-RUNX1T1, CBFB-MYH11 and DEK-NUP214), or NGS detection of FLT3 mutation positive. * Age over 14 years old, male or female. Informed consent must be signed prior to the commencement of all specific study procedures, and for those 14 years of age and older, informed consent must be signed by the patient or an immediate family member. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the condition, the informed consent shall be signed by the legal guardian or the patient's immediate family. Exclusion Criteria: * Patients who intend to undergo hematopoietic stem cell transplantation within 4 weeks * The diagnosis is APL * Those who were not considered suitable for inclusion by the researchers.

Locations (1)

Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Outcomes

Primary Outcomes

relapse-free survival rate

Time frame: up to 6 months

Secondary Outcomes

Measurable Residual Disease

Time frame: up to 6 months

Proportion of MRD turning negative

Time frame: up to 6 months

Overall survival(OS ) rate

Time frame: From the time the patients participated in the clinical trial until the patient died

Cumulative relapse rate

Time frame: From the time the patients participated in the clinical trial until the patient relapsed

Adverse Events (AEs)

Time frame: up to 2 years

The incidence of adverse events such as serious infections during treatment

Time frame: up to 2 years

Central Contacts

Hui Wei, Doctor

CONTACT

13132507161 weihui@ihcams.ac.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.