Acute myeloid leukaemia
Conditions
Interventions
Experimental group:All patients were given induction therapy with the GAL regimen: G-CSF: 300 ug intramuscularly once daily from day 1 to day 7 (if the weight is less than 40 kilograms or more than 10
AZA: 75 mg/m2 from day 1 to day 7
Lisaftoclax: 200 mg on day 1
400 mg on day 2
600mg d3-21
Sponsors
The Second Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Newly diagnosed patients with acute myeloid leukemia meeting the WHO (2016) criteria; (2) Age >= 18 years old, gender not restricted; (3) Expected survival time >= 3 months; (4) Male and female patients who may have children have agreed and taken effective contraceptive measures; (5) Before the start of all specific research procedures, informed consent must be signed, either by the patient themselves or by their immediate family members. Considering the patient's condition, if the patient's signature is not conducive to the treatment of the disease, the informed consent can be signed by the legal guardian or the patient's immediate family members.
Exclusion criteria
Exclusion criteria: (1) Acute promyelocytic leukemia with PML-RARA fusion gene; (2) AML patients with BCR/ABL1 mutation or CML blast crisis stage; (3) Patients with evidence of central nervous system leukemia before treatment; (4) Refractory patients (those who have received induction chemotherapy before but can receive hydroxyurea-based cell reduction therapy); (5) Patients with other organ malignancies (requiring treatment); (6) Pregnant or lactating women; (7) Severe uncontrolled active infections; (8) Severe heart disease; (9) Moderate to severe liver dysfunction (moderate to severe liver dysfunction according to Child-Pugh classification method); (10) Severe renal dysfunction (such as Ccr <=29 mL/min or requiring hemodialysis); (11) Positive HIV serum antibody; (12) Patients considered ineligible by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) rate;MRD negativity rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 30-day and 60-day mortality rate;The duration of 3-4 degree bone marrow suppression; | — |
Countries
China
Contacts
Public ContactLai Yinghui
The Second Affiliated Hospital of Guangxi Medical University
Outcome results
None listed