elderly de novo acute myeloid luekemia
Conditions
Interventions
Group 1 :VCA-DMAG
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed acute myeloid leukemia (non-M3). Have not received treatment before and cannot accept standard cytarabine and anthracycline induction regimen treatment due to age or comorbidity or patient preference; 2. Age >= 60 years old, male or female, expected survival time greater than 3 months; 3. Estimated creatinine clearance >= 30 mL/min; 4. AST and ALT <= 3.0 x ULN (unless considered due to leukemic organ involvement). Bilirubin <= 1.5 x ULN (unless considered due to leukemic organ involvement); 5. ECOG <= 2; 6. Able to understand and voluntarily provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16) or t(16;16); 2. Active central nervous system leukemia; 3. A history of myeloproliferative neoplasms (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myelogenous leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR- ABL1 translocation; 4. HIV-positive patients and/or HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive tests); 5. Suffering from chronic respiratory diseases requiring continuous oxygen inhalation, or having obvious history of kidney, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases; 6. Suffering from malabsorption syndrome or other diseases that exclude the enteral route of administration; 7. Clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, myocardial infarction and congestive heart failure within one year before enrollment patients, and patients with coronary heart disease who have clinical symptoms and need drug treatment; 8. Active, uncontrolled severe infection; 9. There is a history of other malignant tumors within 2 years, except for the following cases: adequately treated carcinoma in situ of the cervix or carcinoma in situ of the breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; 10. White blood cell count > 25 x 10^9/L (hydroxyurea or leukapheresis can meet this standard); 11. Mental disorders that will hinder research participation; 12. Participants have received the following treatments: hypomethylation agents, venetoclax and/or chemotherapy for myelodysplastic syndrome (MDS), solid organ transplantation; 13. Any other circumstances that the investigator believes that the patient is not suitable to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| complete remission;overall survival;overall response rate;General Health Status/Quality of Life; | — |
Countries
China
Contacts
Public ContactBing Xu
The First Affiliated Hospital of Xiamen University
Outcome results
None listed