The First Affiliated Hospital of Xiamen University
Phase
Phase 1
Started
2025-03-15
Last updated
2025-02-24
Condition(s) studied
Acute Myeloid LeukemiaRelapseRefractory AML
Investigational drug(s) / intervention(s)
CVA
CVA: Chiglitazar Sodium in combination with Venetoclax and Azacitidine
Study summary
To investigate the safety and efficacy of the CVA regimen, composed of Chiglitazar Sodium in combination with Venetoclax and Azacitidine, in the treatment of patients with refractory/relapsed acute myeloid leukemia (R/R AML).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Acute myeloid leukemia (AML) confirmed by histology. Relapsed or refractory AML, including: a) Refractory disease is defined as no remission after at least one prior treatment. b) Disease relapse is defined as 5% or more blasts in the bone marrow after remission. c) Patients with AML arising from 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 of more than 3 months;
3. Estimated creatinine clearance ≥ 50 mL/min;
4. AST and ALT ≤ 3.0 x ULN (unless considered due to leukemia organ involvement), bilirubin ≤ 3.0 x ULN (unless considered due to leukemia organ involvement);
5. ECOG ≤ 2;
6. Subjects are non-pregnant or using contraceptive measures during treatment;
7. Capable of understanding and voluntarily providing informed consent.
Exclusion Criteria:
1. Acute promyelocytic leukemia (APL);
2. Active central nervous system leukemia;
3. Patients with clinically significant QTc interval prolongation (males \> 450 ms; females \> 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, history of myocardial infarction and congestive heart failure within the year prior to enrollment, and patients with clinically symptomatic coronary heart disease requiring medication;
4. Active, uncontrolled severe infection;
5. Other non-myeloid malignancies within the past 2 years;
6. Mental disorders that would impede study participation;
7. Previous solid organ transplantation (pre-treatment with SCT is allowed, but not allowed if the patient has GVHD or is still receiving immunosuppressive/GVHD treatment);
8. Any other conditions that, in the opinion of the investigator, make the patient unsuitable to participate in this trial.
Primary outcome measure(s)
Complete remission rate (CR) — Up to 36 months The absolute neutrophil count is ≥1.0 × 10\^3/μL, the platelet count is ≥1.0 × 10\^5/μL, independent of red blood cell transfusions, and the percentage of bone marrow blasts is \<5%. There are no circulating bone marrow blasts and blasts with Auer rods in the peripheral blood; no extramedullary disease is present.
Complete Remission with Incomplete Count Recovery (CRi) — Up to 36 months Meeting all CR criteria except for residual neutropenia \<1.0 × 10\^3/μL (1000/μL) or thrombocytopenia \<1.0 × 10\^5/μL (100,000/μL). Dependence on red blood cell (RBC) transfusions is also defined as CRi.
Partial remission rate (PR) — Up to 36 months Meets all hematological criteria for CR, but the percentage of blasts in the bone marrow aspirate sample has decreased by at least 50%, reaching between 5% and 25%.
Trial sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Xiamen University
Xiamen
Fujian
Recruiting
More The First Affiliated Hospital of Xiamen University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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