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

NCT06737523 | Recruiting Phase 1

• 1 other identifier: XMDYYYXYK-15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Myeloid Leukemia; Relapse; Refractory AML

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 36 months

• 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.

  Up to 36 months

• 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%.

  Up to 36 months

Study Arms (1)

CVA

EXPERIMENTAL

Chiglitazar Sodium in combination with Venetoclax and Azacitidine

Drug: CVA

Interventions

CVA DRUG

Chiglitazar Sodium in combination with Venetoclax and Azacitidine

CVA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bing Xu

  The First Aiffiliated hosptical of xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xu

CONTACT

18750918842; xubingzhangjian@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 17, 2024
• Study Start: March 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)