Actively Recruiting
A Multicenter, Prospective, Single-arm Clinical Study of Chiglitazar Sodium Combined With Venetoclax and Azacitidine for Refractory/Relapsed Acute Myeloid Leukemia
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-24
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a treatment regimen called CVA, which combines Chiglitazar Sodium with Venetoclax and Azacitidine, for patients with refractory or relapsed acute myeloid leukemia (R/R AML). This phase 1, multicenter, single-arm clinical study aims to understand how well this combination works in patients who have not responded to previous treatments or whose disease has returned. The treatment involves taking Sogletanib at 48 mg once daily, Venetoclax at 400 mg once daily for 4 weeks, and Azacitidine at 100 mg daily on days 1 through 7 in 28-day cycles, with at least 2 cycles planned. Venetoclax dosage may be adjusted based on blood concentration one week after starting. Patients with stable or progressive disease after 2 cycles may receive up to 1 or 2 additional cycles. If no improvement occurs, patients may leave the study and consider other treatments such as stem cell transplantation. Hydroxyurea may be used to lower high white blood cell counts before starting Venetoclax if needed. Participants will undergo regular assessments during the study, including monitoring blood levels of Venetoclax, clinical evaluations, and laboratory tests to track response to treatment. Researchers will measure outcomes such as complete remission rate, complete remission with incomplete blood count recovery, and partial remission over a period of up to 36 months. The study is sponsored by The First Affiliated Hospital of Xiamen University and will run until the end of 2026.
CONDITIONS
Brief Title
Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of acute myeloid leukemia (AML) with relapsed or refractory disease
- Age 18 years or older, male or female, with expected survival over 3 months
- Estimated creatinine clearance of 50 mL/min or higher
- AST and ALT levels no more than 3 times the upper limit of normal (unless due to leukemia involvement)
- Bilirubin no more than 3 times the upper limit of normal (unless due to leukemia involvement)
- ECOG performance status of 2 or less
- Non-pregnant or using contraception during treatment
- Able to understand and voluntarily provide informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL)
- Active central nervous system leukemia
- Significant heart problems including QTc prolongation, ventricular tachycardia, atrial fibrillation, second-degree heart block, recent heart attack or congestive heart failure, or symptomatic coronary heart disease needing medication
- Active, uncontrolled severe infection
- Non-myeloid cancers within the past 2 years
- Mental disorders preventing participation
- Previous solid organ transplant (stem cell transplant before treatment allowed if no graft-versus-host disease or immunosuppressive treatment ongoing)
- Any other condition judged by investigators to make participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - At least 2 cycles of 28 days each, up to 4 cycles
Participants receive Chiglitazar Sodium combined with Venetoclax and Azacitidine in 28-day cycles. Venetoclax dose is adjusted based on drug concentration tested one week after starting. Participants receive at least 2 cycles and up to 4 cycles depending on disease response.
At least 2 cycles of treatment with regular monitoring visits including drug concentration testing after 1 week of Venetoclax
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
B
Bing Xu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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