Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of Xiamen University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
CVA
DrugChiglitazar Sodium in combination with Venetoclax and Azacitidine
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: CVAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete remission rate (CR)
The absolute neutrophil count is ≥1.0 × 10\^3/μL, the platelet count is ≥1.0 × 10\^5/μL, independent of red blood cell transfusions, and the percentage of bone marrow blasts is \<5%. There are no circulating bone marrow blasts and blasts with Auer rods in the peripheral blood; no extramedullary disease is present.
Time frame
Up to 36 months2
Complete Remission with Incomplete Count Recovery (CRi)
Meeting all CR criteria except for residual neutropenia \<1.0 × 10\^3/μL (1000/μL) or thrombocytopenia \<1.0 × 10\^5/μL (100,000/μL). Dependence on red blood cell (RBC) transfusions is also defined as CRi.
Time frame
Up to 36 months3
Partial remission rate (PR)
Meets all hematological criteria for CR, but the percentage of blasts in the bone marrow aspirate sample has decreased by at least 50%, reaching between 5% and 25%.
Time frame
Up to 36 monthsSponsors and contacts
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Source ClinicalTrials.gov