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

NCT ID: NCT06737523

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2026-12-31

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).

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 If the disease still shows no improvement, they will be withdrawn from the clinical study and other treatment options will be considered, including allogeneic hematopoietic stem cell transplantation.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.

Conditions

Acute Myeloid Leukemia; Relapse; Refractory AML

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CVA

Chiglitazar Sodium in combination with Venetoclax and Azacitidine

Group Type: EXPERIMENTAL

CVA

Intervention Type: DRUG

Chiglitazar Sodium in combination with Venetoclax and Azacitidine

Interventions

CVA

Chiglitazar Sodium in combination with Venetoclax and Azacitidine

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Bing, Xu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bing Xu

Role: PRINCIPAL_INVESTIGATOR

The First Aiffiliated hosptical of xiamen University

Locations

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bing Xu

Role: CONTACT

xubingzhangjian@126.com

18750918842

Facility Contacts

Bing Xu

Role: primary

xubingzhangjian@126.com

18750918842

Other Identifiers

XMDYYYXYK-15

Identifier Type: -

Identifier Source: org_study_id