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Clinical Trials in China / NCT06737523
Recruiting Phase 1

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

NCT06737523 · tracked via the Priya Life Science China tracker
Sponsor
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)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting

More The First Affiliated Hospital of Xiamen University trials in China

Other trials for the same condition

Official registry record

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.

View NCT06737523 on ClinicalTrials.gov ↗ ← All trials in China