Acute myeloid leukemia
Conditions
Interventions
Group 1 (Combined with standard-intensity chemotherapy group):chidamide 20mg biw po d1, d4, d8, d11
azacitidine 100mg Qd iH d1-d5
daunorubicin 40mg/m2 Qd d4-d6
cytarabine 100mg/m2 Qd d4-d10
Group 2 (Combined with lower-intensity chemotherapy group):Chidamide 20mg biw Po D1, D4, D8, D11
Azacitidine 100mg Qd iH d1-d5
Homoharringtonine 1mg Qd d4-17
Cytarabine 15mg/m2 Q12h iH d4-17
Recombin
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients with primary AML meeting the 2016 WHO AML diagnostic criteria as confirmed by bone marrow morphology and immunology. 2) Chromosomal or genetic requirements: -7/del(7q) or translocation of the q23 segment of chromosome 11 to other chromosomes, including but not limited to t(4;11)(q21;q23)(MLL-AF4), t(9;11)(p22;q23)(MLL-AF9), t(11;19)(q23;p13.3)(MLL-ENL) , t(10; 11)(p12; q23)(MLL-AF10) and t(6; 11)(q27; q23)(MLL-AF6), or TP53 pathogenic somatic mutations on chromosome 17 (mutant allele frequency of at least 10% with or without wild-type TP53 allele deletion), and i(17q), -17/add(17p ) or del(17p). 3) ECOG score <3 and age 18-75 years (including 18 and 75 years) 4) Bone marrow morphology suggesting active myeloproliferation (5) Normal liver and kidney function, blood bilirubin = 35 µmol/L, AST/ALT below 2 times the upper limit of normal value, blood creatinine = 150 µmol/L (6) Normal cardiac function (7) Informed consent signed by the patient or family
Exclusion criteria
Exclusion criteria: 1) Patients with clear central nervous system invasion 2) Significant abnormalities in liver and kidney function beyond the inclusion criteria 3) Severe heart disease, including myocardial infarction, cardiac insufficiency (4) ECG results: QT interval greater than 450 ms 5) Simultaneous malignant tumors of other organs 6) Patients with active tuberculosis and HIV-positive patients 7) Pregnant or lactating women 8) allergy or significant contraindication to any of the drugs involved in the program 9) Patients with ECOG = 3, CCI > 1 (comorbidity index), ADL < 100 (scale of daily living) (10) unable to understand or comply with the study protocol (11) previous history of intolerance or allergy to similar drugs 12) Patients with MDS under 18 years of age or over 75 years of age (excluding 18 and 75 years of age) (13) MDS patients who have previously received demethylation drugs (14) Concurrent participants in other clinical studies 15) The presence of any other circumstances that prevent the study from being conducted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relapse-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response; with incomplete count recovery;Partial remission;stable disease;Cytogenetic response rates;Overall survival rate;Early mortality; | — |
Countries
China
Contacts
Public ContactYu Wu
West China Hospital of Sichuan University
Outcome results
None listed