Venetoclax, Chidamide, and Chiglitazar Sodium (VCC) in Patients With Relapsed/Refractory Acute Myeloid Leukemia

NCT07783100 | Recruiting Phase 2

• 1 other identifier: 20260820VCC
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of venetoclax, chidamide, and chiglitazar sodium (VCC) in patients with relapsed or refractory acute myeloid leukemia (R/R AML).

Conditions

Relapsed or Refractory Acute Myeloid Leukemia

Keywords

venetoclax; chidamide; chiglitazar sodium

Outcome Measures

Primary Outcomes (1)

• Composite Complete Remission Rate (CR + CRi)

  The proportion of participants who achieve complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) following VCC treatment. Treatment response will be assessed according to the response criteria specified in the study protocol.

  Up to 12 months

Secondary Outcomes (4)

• 1-Year Progression-Free Survival (PFS)

  Up to 12 months

• 1-Year Overall Survival (OS)

  Up to 12 months

• Change in Health-Related Quality of Life Assessed by EQ-5D-5L

  Up to 24 months

• Incidence of Adverse Events

  Up to 12 months

Study Arms (1)

VCC

EXPERIMENTAL

Chidamide, venetoclax, chiglitazar sodium.

Drug: venetoclax, chidamide, and chiglitazar sodium (VCC)

Interventions

venetoclax, chidamide, and chiglitazar sodium (VCC) DRUG

Participants will receive oral chidamide 30 mg twice weekly for 2 weeks, venetoclax 200 mg once daily for 2 weeks, and chiglitazar sodium 48 mg once daily on Days 1-28 of each 28-day cycle. At least two cycles will be administered. Dose modifications are permitted according to clinical condition, laboratory findings, adverse events, and venetoclax plasma concentrations.

VCC

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed acute myeloid leukemia (AML) with relapsed or refractory disease, including:
• Refractory AML, defined as failure to achieve remission after at least one prior treatment;
• Relapsed AML, defined as ≥5% blasts in the bone marrow after a previous remission;
• AML arising from myelodysplastic syndrome (including CMML) or myeloproliferative neoplasms (secondary AML or therapy-related AML \[t-AML\]) is also eligible.
• Age ≥18 years, regardless of sex, with an expected survival of \>3 months.
• Estimated creatinine clearance ≥50 mL/min.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × the upper limit of normal (ULN), unless the abnormality is considered attributable to leukemic organ involvement; total bilirubin ≤3.0 × ULN, unless the abnormality is considered attributable to leukemic organ involvement.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
• Participants must not be pregnant and must agree to use effective contraception during study treatment.
• Ability to understand the study and willingness to provide written informed consent.

You may not qualify if:

• Acute promyelocytic leukemia (APL).
• Active central nervous system leukemia.
• Clinically significant cardiovascular disease, including any of the following:
• Clinically significant QTc prolongation (QTc \>450 ms in males or \>470 ms in females);
• Ventricular tachycardia;
• Second-degree atrioventricular block;
• Myocardial infarction within 1 year prior to enrollment;
• Congestive heart failure;
• Coronary artery disease requiring medical treatment.
• Active, uncontrolled severe infection.
• Other non-hematologic malignancies within the previous 2 years.
• Psychiatric disorders that may interfere with participation in the study.
• Previous solid organ transplantation. Prior stem cell transplantation (SCT) is permitted; however, patients with graft-versus-host disease (GVHD) or those receiving ongoing immunosuppressive or GVHD-directed therapy are not eligible.
• Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

the First affiliated hospital of xiamen university

Xiamen, Fujian, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Leukemia, Myeloid, Acute

Interventions

venetoclax; N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide

Condition Hierarchy (Ancestors)

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

Study Officials

• Bing Xu

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bing Xu, PhD

CONTACT

18750918842; xubingzhangjian@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Bing Xu

Model Details: Participants will receive oral chidamide 30 mg twice weekly for 2 weeks, venetoclax 200 mg once daily for 2 weeks, and chiglitazar sodium 48 mg once daily on Days 1-28 of each 28-day cycle. At least two cycles will be administered. Dose modifications are permitted according to clinical condition, laboratory findings, adverse events, and venetoclax plasma concentrations.

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): November 11, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

CN (1)