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
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%.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Dongguan General Hosptial
Dongguan, Guangdong, China
RECRUITINGFoshan First People's Hospital
Foshan, Guangdong, China
Composite complete remission (CRc)
composite complete remission,CRc: CR + CRi + MLFS
Time frame: 2 months
the rate of MRD turn negative
minimal residual disease turn negative
Time frame: 6 months
DoR
Duration of remission
Time frame: 2 year
RFS
Relapsed-free survival
Time frame: 1 year
OS
Overall survival
Time frame: 1 year
AE
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
Time frame: Throughout the study until the end, up to 2 years
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Induction Therapy
Induction Therapy
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGThe Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
RECRUITINGThe Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
RECRUITINGShenzhen second people's Hospital
Shenzhen, Guangdong, China
RECRUITING...and 3 more locations