Acute Myeloid Leukemia
Conditions
Interventions
Treatment group:Venetoclax 100mg d1,200mg d2,400mg d3-14 po
Azacitidine 75mgm2 d1-7 sc
Cladribine 5mg/m2 d1-5 iv
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Patients=18 years old with previously untreated acute myeloid leukemia (AML). Prior therapy with hydroxyurea, hematopoietic growth factors, all-trans retinoic acid (ATRA), or a total dose of cytarabine up to 2 g (for emergency use for stabilization) is allowed. a. Patients aged=60 years or b. Patients who are unfit for standard induction therapy may be eligible after discussion with primary investigator. c. Patients aged (See Annex I for details) 2) The main organ function is not obviously damaged: Creatinine =1.5 x upper limit of normal (ULN), bilirubin=2mg/dl. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =2.5x ULN. 3)Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol. 4)Life expectancy =12 weeks
Exclusion criteria
Exclusion criteria: 1)Pregnant women, family plan and lactating patient 2)Prior therapy with venetoclax or HAM. 3)Patient with documented hypersensitivity to any of the components of the chemotherapy program. 4)Acute promyelocytic leukemia (AML-M3) 5)WBC=25X109/L before treatment(Arac or hydroxyurea can be used for tumor burden reduction) 6) Received strong and/or moderate CYP3A inducers within 7 days before treatment 7) Mental illness or other medical condition that does not fully comply with trial treatment or follow-up requirements 8)Uncontrolled active infection 9)Patients with central nervous system leukemia 10) HIV-positive patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite complete remission rate;median remission time; | — |
Secondary
| Measure | Time frame |
|---|---|
| composite complete remission rate;MRD negative rate;Median time for blood cell recovery;CRc for different risk stratified subgroups;overall survival;progression free survival;safety; | — |
Countries
China
Contacts
Public ContactGao Sujun
The First Hospital of Jilin University
Outcome results
None listed