Acute Myeloid Leukemia
Conditions
Keywords
ABC-14 regimen, 3+7 regimen, AB-14 regimen
Brief summary
To compare the efficacy and safty of ABC-14 regimen with the traditional 3+7 regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia
Detailed description
Acute myeloid leukemia (AML) is a clonal malignant blood disease with genetic heterogeneity and originated from hematopoietic stem progenitor cells.In the past 50 years, the 3+7 induction regimen represented by cytotoxic drugs (including anthracyclines/anthraquinones combined with cytarabine) has remained the standard induction regimen for newly diagnosed AML patients with intensive chemotherapy. In AML patients \<60 years old, the 3+7 regimen induces a complete response rate of 60% to 80%, but the treatment-related mortality is as high as 13%, and more than half of the patients face the threat of relapse, and the 5-year overall survival rate is about 35% to 40%.
Interventions
DRUGChidamide
Induction Therapy
DRUGVenetoclax
Induction Therapy
DRUGazacitidine
Induction Therapy
DRUGAnthracyclines or anthraquinones
Induction Therapy
DRUGcytarabine
Induction Therapy
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with AML (the diagnostic criteria refer to WHO2022 standard, non-APL), and have not received systemic anti-leukemia therapy (except hydroxyurea, low-dose cytarabine and other tumor reduction pretreatments); 2. Age ≥18 years old; 3. ECOG≤4; 4. The fertile woman agrees to use effective contraception during the treatment period and up to 3 months after the end of the treatment; Sign the informed consent form.
Exclusion criteria
1. Known history of allergy to the investigational drug; 2. Resistance to azacytidine, azacitidine, Venetoclax; 3. Inability to take oral medication; 4. Combined with uncontrolled active infections (including bacterial, fungal or viral infections); 5. Combined with uncontrolled major organ dysfunction: cardiac insufficiency, decompensated liver insufficiency, moderate/severe renal insufficiency, etc.; 6. Participating in other clinical studies that affect the main purpose of this study; Patients deemed unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite complete remission (CRc) | 2 months | composite complete remission，CRc: CR + CRi + MLFS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RFS | 1 year | Relapsed-free survival |
| OS | 1 year | Overall survival |
| the rate of MRD turn negative | 6 months | minimal residual disease turn negative |
| DoR | 2 year | Duration of remission |
| AE | Throughout the study until the end, up to 2 years | Incidence of of grade 3-4 adverse events/Duration of severe myelosuppression/ Incidence of severe infection/Treatment-related mortality, according to Common Terminology Criteria for Adverse Events, versions 5.0 |
Countries
China
Contacts
Primary ContactJianyu Weng
Backup ContactDu Xin
Outcome results
None listed