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RecruitingPhase 1NCT06737523

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

A Multicenter, Prospective, Single-arm Clinical Study of Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of Refractory/Relapsed Acute Myeloid Leukemia (R/R AML)

Sponsor

The First Affiliated Hospital of Xiamen University

Enrollment

30 participants

Start Date

Mar 15, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid LeukemiaRelapseRefractory AML

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

Min Age: 18 Years

Inclusion Criteria7

  • 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;
  • Age ≥18 years, male or female, with an expected survival of more than 3 months;
  • Estimated creatinine clearance ≥ 50 mL/min;
  • 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);
  • ECOG ≤ 2;
  • Subjects are non-pregnant or using contraceptive measures during treatment;
  • Capable of understanding and voluntarily providing informed consent.

Exclusion Criteria8

  • Acute promyelocytic leukemia (APL);
  • Active central nervous system leukemia;
  • 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;
  • Active, uncontrolled severe infection;
  • Other non-myeloid malignancies within the past 2 years;
  • Mental disorders that would impede study participation;
  • 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);
  • Any other conditions that, in the opinion of the investigator, make the patient unsuitable to participate in this trial.

Interventions

DRUGCVA

Chiglitazar Sodium in combination with Venetoclax and Azacitidine

Locations(1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

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NCT06737523

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