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Recruiting NCT07131059

MRD-positive AML Clinical Study

No phase Interventional AML, Adult

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ivosidenib, Gilteritinib, Venetoclax, Avapritinib.
Who it may be relevant to
Registry conditions: AML, Adult. Basic parameters: from 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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.

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.

Interventions

  • 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.

Primary outcome measures

  • relapse-free survival rate [Time frame: up to 6 months]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Blood Diseases Hospital — Tianjin

Identifiers

NCT: NCT07131059 · IIT2024032

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗