Chiglitazar, venetoclax and azacitidine for returning or resistant acute myeloid leukemia
Tests CVA drugs in returning or resistant acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML
Key facts
- Where
- Xiamen, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose acute myeloid leukemia (AML) came back or did not respond to earlier treatment. They will get chiglitazar sodium with venetoclax and azacitidine.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Relapsed or refractory AML confirmed by tissue test. Refractory means no remission after at least one earlier treatment. Relapse means 5% or more blasts in the bone marrow after remission. AML that arose from myelodysplastic syndromes or myeloproliferative neoplasms can also join.
- Earlier treatment
- At least one earlier treatment that did not lead to remission, or remission followed by relapse. A previous stem cell transplant is allowed, but not if graft-versus-host disease (GVHD) is present or immunosuppressive or GVHD treatment is still ongoing.
Main reasons for not taking part
- Acute promyelocytic leukemia (APL)
- Active leukemia in the central nervous system
- Serious heart rhythm problems or recent heart attack or heart failure
- Active, uncontrolled severe infection
- Other non-myeloid cancer within the past 2 years or earlier solid organ transplant
Read by machine on 12 November 2026.
Where in China
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaContact: Bing XuTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital of Xiamen University
- Trial code
- NCT06737523
- Record updated
- 24 February 2025
- Original description
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).Read full original descriptionShow less
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)
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).
Inclusion: 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: 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); Active, uncontrolled severe infection; Other non-myeloid malignancies within the past 2 years; Mental disorders that would impede study participation; Any other conditions that, in the opinion of the investigator, make the patient unsuitable to participate in this trial; 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; Acute promyelocytic leukemia (APL); Active central nervous system leukemia.