Acute Myeloid Leukemia
Conditions
Interventions
Intervention group:Treatment induction: Venetoclax 100mg d1,200mg d2,400mg d3-28,Azacitidine 75mg/m^2 d1-7
Consolidation therapy:Cytarabine 2-3g/m^2 q12h d1-3
Maintenance therapy:
Favorable risk groups: AML with MRD- :Venetoclax 400mg d1-14,Azacitidine 75mg/m^2 d1-5,6cycles
AML with MRD+: Allogeneic HCT or Maintenance therapy
Intermediate, Poor/adverse risk groups: Allogeneic HCT or Maintenance therapy
Sponsors
the Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Gender: Male or female; 2. Age: 18–65 years; 3. Capable of tolerating intensive chemotherapy; 4. Confirmed diagnosis of newly diagnosed AML per the *World Health Organization (WHO) Classification of Tumors of Hematopoietic and Lymphoid Tissues, 2016*; 5. Untreated AML (prior use of hydroxyurea, cumulative low-dose cytarabine =30 mL/min; 9. Ability to comprehend the study protocol and voluntary willingness to participate; 10. Provision of written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Patients with acute promyelocytic leukemia (APL); 2. Patients with ETO-positive AML; 3. Patients with AML complicated by central nervous system (CNS) infiltration; 4. Patients with myeloid sarcoma; 5. Patients with prior exposure to hypomethylating agents or BCL-2 inhibitors; 6. Patients with active, investigator-judged uncontrollable infection; 7. Patients with active hepatitis B,hepatitis C, or human immunodeficiency virus (HIV) infection; 8. Patients with heart failure (New York Heart Association [NYHA] functional class 3–4); 9. Pregnant or lactating patients; 10. Other patients deemed ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete blood count;Bone marrow aspirate;immunophenotyping;chromosome analysis;Fusion gene;gene mutation;Bone marrow biopsy;The composite complete remission rate(CRc) at the end of the 4-cycle induction therapy;The complete remission rate at the end of the 1-cycle therapy;The complete remission rate at the end of the 2-cycle therapy;Secondary reseaThe rate of MRD negativity at the end of induction treatmentrch endpoints;The rate of MRD negativity at the end of consolidation therapy;overall survival(OS);progression free survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| performance status;C-reactive protein(CRP); | — |
Countries
China
Contacts
Public ContactChunting Zhao
the Affiliated Hospital of Qingdao University
Outcome results
None listed