NCT06737523 Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML
| NCT ID | NCT06737523 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The First Affiliated Hospital of Xiamen University |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-15 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-03-15 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 ≥18 years, male or female, with an expected survival of more than 3 months; 3. Estimated creatinine clearance ≥ 50 mL/min; 4. 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); 5. ECOG ≤ 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.
Contact & Investigator
Bing Xu
PRINCIPAL INVESTIGATOR
The First Aiffiliated hosptical of xiamen University
Frequently Asked Questions
Who can join the NCT06737523 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06737523 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06737523 currently recruiting?
Yes, NCT06737523 is actively recruiting participants. Contact the research team at xubingzhangjian@126.com for enrollment information.
Where is the NCT06737523 trial being conducted?
This trial is being conducted at Xiamen, China.
Who is sponsoring the NCT06737523 clinical trial?
NCT06737523 is sponsored by The First Affiliated Hospital of Xiamen University. The principal investigator is Bing Xu at The First Aiffiliated hosptical of xiamen University. The trial plans to enroll 30 participants.
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