Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
876 participants
INTERVENTIONAL
2025-01-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IC regiment for Fit-AML
Standard Chemotherapy
Standard Chemotherapy includes IA(Idarubicin combined with Cytarabine) or DA(Daunorubicin combined with Cytarabine). IDA is given by venous drip daily at 12mg/m2, or DNR is given by venous drip daily at 60mg/m2, from day 1-3, combined with Ara-C at 100mg/m2 by continuously venous drip from day 1-7.
HVA regiment for Fit-AML
HVA
Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7. Venetoclax (VEN) is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 14. Azacitidine (AZA) is given 75 mg/m2 subcutaneously from day 1 to 7.
VA regiment for unfit-AML
VA
VEN is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 28, and AZA (75 mg/m2) is given subcutaneously from day 1 to 7.
HVA regiment for unfit-AML
HVA
Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7. Venetoclax (VEN) is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 14. Azacitidine (AZA) is given 75 mg/m2 subcutaneously from day 1 to 7.
Interventions
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HVA
Homoharringtonine (HHT) is given by venous drip daily at 1 mg/m2 from day 1 to 7. Venetoclax (VEN) is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 14. Azacitidine (AZA) is given 75 mg/m2 subcutaneously from day 1 to 7.
VA
VEN is given 100 mg on day 1, 200 mg on day 2, and 400 mg orally from day 3 to day 28, and AZA (75 mg/m2) is given subcutaneously from day 1 to 7.
Standard Chemotherapy
Standard Chemotherapy includes IA(Idarubicin combined with Cytarabine) or DA(Daunorubicin combined with Cytarabine). IDA is given by venous drip daily at 12mg/m2, or DNR is given by venous drip daily at 60mg/m2, from day 1-3, combined with Ara-C at 100mg/m2 by continuously venous drip from day 1-7.
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years old;
* High-risk patients should meet any of the following criteria: ① High risk group according to the European Leukemia Risk stratification (ELN) 2022; (2) Secondary AML (sAML) which develops from myelodysplastic syndrome (MDS), bone marrow hyperplastic tumor (MPN) or chronic myeloid cell leukemia, et.; (3) Treatment-related AML (t-AML), Patients have a history of cytotoxic treatment record or ionizing radiation therapy.
* Patients did not receive anti-AML therapy (except leukopenia therapy, such as hydroxyurea or cytarabine \< 1.0g/d) after the diagnosis of AML;
* Expected survival ≥12 weeks;
* The eastern tumor cooperation group (ECOG) score 3 points or less;
* Kidney function: creatinine clearance acuity 30 ml/min;
* Liver function: ALT \< 5 times normal value, bilirubin \< 3 times normal value;
* Sign the informed consent form and understand and abide by the plan calls for process.
Exclusion Criteria
* With central nervous system leukemia (CNSL) ;
* The cardiac function \> level 2;
* The AIDS virus (HIV) infection;
* Other clinical significance of uncontrolled condition, including but not limited to: (1) out of control, or active systemic infection (viruses, bacteria or fungi); (2) chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) requiring treatment; (3) need to actively deal with the merger of the second tumor;
* Can't take oral treatment or having a gastrointestinal disease impact ing the absorption;
* Being allergy to the experimental drugs;
* Pregnant and lactating women;
* Patients who could not understand or adhere to the study protocol;
* Patients deemed by the investigator to be ineligible for enrollment.
18 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Guangzhou First People's Hospital
OTHER
Guangdong Second Provincial General Hospital
OTHER
Jiangmen Central Hospital
OTHER
Shenzhen Second People's Hospital
OTHER
First Affiliated Hospital of Guangxi Medical University
OTHER
Dongguan People's Hospital
OTHER_GOV
First People's Hospital of Foshan
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Huizhou Municipal Central Hospital
OTHER
Shenzhen Hospital of Southern Medical University
OTHER
Affiliated Hospital of Guangdong Medical University
OTHER
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
First People's Hospital of Chenzhou
OTHER
Hunan Provincial People's Hospital
OTHER
Ganzhou City People's Hospital
OTHER
First Affiliated Hospital of Gannan Medical University
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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Guopan Yu
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NFEC-2024-576
Identifier Type: -
Identifier Source: org_study_id
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