Acute myeloid leukemia (AML)
Conditions
Interventions
Intervention group:Chiglitazar Sodium combined with Venetoclax and Azacitidine (CVA).
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed acute myeloid leukemia. Refractory or relapsed AML, including: a. Refractory disease will be defined as at least 1 prior therapy without remission; b. Disease recurrence is defined as 5% or more blasts in the bone marrow after remission; c. Patients with AML caused by myelodysplastic syndromes (including CMML) or myeloproliferative neoplasms (secondary AML, t-AML) are also eligible; 2. Age>=18 years, male or female, with an expected survival period of more than 3 months; 3. Estimated creatinine clearance >= 50 mL/min; 4. AST and ALT <= 3.0 x ULN (unless thought to be due to leukemic organ involvement). Bilirubin < = 3.0 x ULN (unless thought to be due to leukemic organ involvement); 5.ECOG <=2; 6. Subjects are non-pregnant or have used contraceptive measures during treatment; 7. Able to understand and voluntarily provide informed consent.
Exclusion criteria
Exclusion criteria: 1) Acute promyelocytic leukemia (APL); 2) active central nervous system leukemia; 3) Has clinically significant QTc interval prolongation (> 450 ms in males; Female > 470 ms), patients with ventricular tachycardia and atrial fibrillation, second-degree heart block, onset of myocardial infarction and history of congestive heart failure in the year prior to enrollment, and patients with coronary artery disease with clinical symptoms requiring medication; 4) active, uncontrolled severe infection; 5) Other non-myeloid malignancies within 2 years; 6) psychiatric disorders that would preclude study participation; 7) previous solid organ transplantation (prior treatment with SCT is allowed, but not allowed if the patient has GVHD or is still receiving immunosuppression/GVHD therapy); 8) Any other condition that the investigator considers the patient to be inappropriate to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission (CR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission with incomplete recovery of blood counts (CRi);Partial remission (PR);Progression-free survival (PFS);Survival time (OS); | — |
Countries
China
Contacts
Public ContactBing Xu
The First Affiliated Hospital of Xiamen University
Outcome results
None listed