Chiglitazar Sodium Combined With Venetoclax and Azacitidine (CVA) for the Treatment of R/R AML
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CVA.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia, Relapse, Refractory AML. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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).
Detailed description
1. Sogletanib 48mg per dose, once daily; Venetoclax 400mg per dose, once daily for 4 weeks; Azacitidine 100mg, once daily, days 1-7. 28 days/cycle, at least 2 cycles. 2. The drug concentration of Venetoclax will be tested one week after oral administration, and the dose will be adjusted according to the concentration. 3. After 2 treatment courses, patients with stable disease (SD) or progressive disease (PD) may receive up to 1-2 additional courses. If the disease still shows no improvement, they will be withdrawn from the clinical study and other treatment options will be considered, including allogeneic hematopoietic stem cell transplantation.
Note: In special circumstances based on the patient's condition, laboratory test indicators, and adverse reactions, etc.; for Venetoclax dosage, if the white blood cell count is \>25×10\^9/L before administration, hydroxyurea may be given first to reduce the count to less than 25×10\^9/L before adding Venetoclax, and then the concentration of Venetoclax will be tested and the dose adjusted according to the concentration.
Interventions
- Drug CVA
Chiglitazar Sodium in combination with Venetoclax and Azacitidine
Primary outcome measures
- Complete remission rate (CR) [Time frame: Up to 36 months]
- Complete Remission with Incomplete Count Recovery (CRi) [Time frame: Up to 36 months]
- Partial remission rate (PR) [Time frame: Up to 36 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Xiamen University — Xiamen
Identifiers
NCT: NCT06737523 · XMDYYYXYK-15