Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML

Launched by THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY · Dec 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with acute myeloid leukemia (AML) that has come back or has not responded to previous treatments. The treatment being tested combines three medications: Chiglitazar Sodium, Venetoclax, and Azacitidine. The goal of the study is to determine how safe this combination is and whether it can help patients with this challenging condition.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of AML that is either relapsed or resistant to treatment. They should have a good chance of living for more than three months and meet certain health criteria, such as having acceptable kidney and liver function. Participants should expect to receive the new treatment and will be monitored closely by the study team for any side effects and how well the treatment works. It’s important to know that not everyone is eligible; for instance, patients with specific types of leukemia or other serious health issues may not be able to join.

Gender

ALL

Eligibility criteria

• 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.