MRD-positive AML Clinical Study

NCT07131059 | Recruiting

• 1 other identifier: IIT2024032
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

AML, Adult

Keywords

Measurable Residual Disease

Outcome Measures

Primary Outcomes (1)

• relapse-free survival rate

  up to 6 months

Secondary Outcomes (6)

• Measurable Residual Disease

  up to 6 months

• Proportion of MRD turning negative

  up to 6 months

• Overall survival(OS ) rate

  From the time the patients participated in the clinical trial until the patient died

• Cumulative relapse rate

  From the time the patients participated in the clinical trial until the patient relapsed

• Adverse Events (AEs)

  up to 2 years

Study Arms (7)

With lDH1 gene mutation

EXPERIMENTAL

Ivosidenib 500mg/d d1-28 ；Azacitidine 75mg/m2/d d1-7；Venetoclax400mg/d:d1-28

Drug: Ivosidenib; Drug: Venetoclax

FLT3 gene mutation

EXPERIMENTAL

Gilteritinilb 120mg/d, d1 -28； Venetocax 400mg/d d1-28 400mg

Drug: Gilteritinib; Drug: Venetoclax

NPM1 mutation or IDH2 mutation

EXPERIMENTAL

Azacitidine 75mg/m2/d d1-7；Venetoclax400mg/d d1-21 or Cytarabine 20mg/m2/d d1-10；Venetoclax 600mg/d d1-21

Drug: Venetoclax

c-kit mutation

EXPERIMENTAL

Avapritinib 200mg/ day, 28 days a course

Drug: Avapritinib

Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax

EXPERIMENTAL

Cytarabine 100mg/m2/d, d1-5； Daunorubicin 45mg/m2/d，d1-2；or Idarubicin 10mg/ m2/d，d1-2；or MTZ 8mg/ m2/d d1-2; Venetoclax 400mg d1-7

Drug: Venetoclax; Drug: Daunorubicin; Drug: Cytarabine; Drug: Idarubicin; Drug: MTZ

Cytarabine+HHT+Venetoclax

EXPERIMENTAL

Cytarabine 100mg/ m2/d, d1-5; HHT 2mg/ m2 d1-5; Venetoclax 400mg d1-7

Drug: Venetoclax; Drug: Cytarabine; Drug: HHT

Venetoclax+Azacitidine/Venetoclax+Cytarabine

EXPERIMENTAL

Azacitidine75 mg/m2 day1-7；Venetoclax 400mg day1-21 or，Cytarabine 20mg/m2 /day，day1-10； Venetoclax 600mg day1-21

Drug: Venetoclax; Drug: Cytarabine; Drug: Azacitidine

Interventions

Ivosidenib DRUG

500mg d1-28

With lDH1 gene mutation

Gilteritinib DRUG

120mg d1-28

FLT3 gene mutation

Venetoclax DRUG

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

Cytarabine+HHT+Venetoclax; Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax; FLT3 gene mutation; NPM1 mutation or IDH2 mutation; Venetoclax+Azacitidine/Venetoclax+Cytarabine; With lDH1 gene mutation

Avapritinib DRUG

200mg d1-28.

c-kit mutation

Daunorubicin DRUG

45mg/m2/d d1-2;

Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax

Cytarabine DRUG

100mg/m2/d d1-5

Cytarabine+HHT+Venetoclax; Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax; Venetoclax+Azacitidine/Venetoclax+Cytarabine

Idarubicin DRUG

10mg/m2/d d1-2

Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax

MTZ DRUG

8mg/m2/d d1-2

Daunorubicin/MTZ/Idarubicin+Cytarabine +Venetoclax

HHT DRUG

2mg/m2/d d1-5

Cytarabine+HHT+Venetoclax

Azacitidine DRUG

75mgd/m2 d1-7.

Venetoclax+Azacitidine/Venetoclax+Cytarabine

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who intend to undergo hematopoietic stem cell transplantation within 4 weeks
• The diagnosis is APL

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasm, Residual

Interventions

ivosidenib; gilteritinib; venetoclax; avapritinib; Daunorubicin; Cytarabine; Idarubicin; Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Aza Compounds; Ribonucleosides

Study Officials

• Huui Wei, doctor

  Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Wei, Doctor

CONTACT

13132507161; weihui@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2024
• First Posted: August 20, 2025
• Study Start: May 11, 2024
• Primary Completion (Estimated): May 10, 2026
• Study Completion (Estimated): April 30, 2028
• Last Updated: August 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)