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

RecruitingPhase 1Ages 18 Years - anyAllThe First Affiliated Hospital of Xiamen University
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In plain words

What the trial is, and whether it could suit you

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).

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ18 years, male or female, with an expected survival of more than 3 months; 3. Estimated creatinine clearance โ‰ฅ 50 mL/min; 4. AST and ALT โ‰ค 3.0 x ULN (unless considered due to leukemia organ involvement), bilirubin โ‰ค 3.0 x ULN (unless considered due to leukemia organ involvement); 5. ECOG โ‰ค 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.
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What it tests

  • CVA
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Where

1 site
The First Affiliated Hospital of Xiamen University
Xiamen, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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