Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of R/R AML

NCT ID: NCT05305859

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-12
• Study Completion Date: 2027-06-30

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) in the Treatment of relapsed and/or refractory AML

Detailed Description

Patients with relapsed and/or refractory AML have inferior outcomes. The regimen of Venetoclax and Azacitidine has been widely used in the treatment of RR AML and has proved to achieve CR rate of 30% ~ 40%. However, the median duration of response (DOR) of this regimen is about one year. Chidamide is a histone deacetylase (HDAC) inhibitor and preclinical data showed adding low-dose Chidamide to venetoclax could significantly promoted apoptosis of leukemia cell lines. Meanwhile, the Venetoclax Combining Chidamide and Azacitidine (VCA) regimen was applied to 2 patients with refractory AML. This regimen was well tolerated and both patients achieved CR after one cycle. Thus, we register this clinical trial and evaluate the safety and efficacy of VCA regimen.

Conditions

Leukemia, Myeloid, Acute; Relapsed Adult AML; Refractory Leukemia

Study Design

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

Study Groups

venetoclax combining chidamide and azacitidine (VCA)

28 days per cycle × at least 2 cycles；

1) chidamide 30mg biw × 2weeks；2) venetoclax 200mg/d × 2 weeks 3) azacitidine 100mg/d d1-7

Group Type: EXPERIMENTAL

venetoclax combining chidamide and azacitidine (VCA)

Intervention Type: DRUG

information already included in arm/group descriptions

Interventions

venetoclax combining chidamide and azacitidine (VCA)

information already included in arm/group descriptions

Intervention Type: DRUG

Other Intervention Names

VCA

Eligibility Criteria

Inclusion Criteria

• Age ≥18
• Relapsed and refractory patients with acute myeloid leukemia via morphology and immunology
• ECOG：0-2
• Life expectancy ≥ 3 months
• Adequate laboratory parameters during the screening period as evidenced by the following:

1. Creatinine clearance≥30 mL/min and serum Creatinine ≤ 160µmol/L

2. ALT and AST ≤ 3 × upper limit of normal (ULN)

3. Able to understand and sign an informed consent form (ICF).

Exclusion Criteria

• Diagnosis of acute promyelocytic leukemia (APL)
• Central nervous system leukemia
• Uncontrolled or significant cardiovascular disease, including any of the following:

1. Bradycardia of less than 50 beats per minute, unless the subject has a pacemaker; Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);

2. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg; History of clinically relevant ventricular arrhythmias (eg, ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes);

3. History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);

4. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening;

5. History of New York Heart Association Class 3 or 4 heart failure;

6. Complete left bundle branch block;

7. Known history of left ventricular ejection fraction (LVEF) ≤45% or less than the institutional lower limit of normal;

• Active acute or chronic systemic fungal, bacterial, or viral infection not well controlled by antifungal, antibacterial or antiviral therapy;
• Suffered from other non-myeloid malignancies within 2 years, except adequately treated non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated with no evidence of disease
• Females who are pregnant or breastfeeding;
• Mental disorders that hinder research participation
• Previous solid organ transplantation (SCT treatment is allowed in advance, but if the patient has GVHD or is still receiving immunosuppression/GVHD treatment, it is not allowed)
• Any other situation where the investigator believes that the patient should not participate in this trial

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

Sponsors

Fujian Provincial Hospital

OTHER

Sponsor Role: collaborator

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Zhangzhou manicipal hospital of Fujian Province

UNKNOWN

Sponsor Role: collaborator

Jieyang People's Hospital

OTHER

Sponsor Role: collaborator

Dongguan People's Hospital

OTHER_GOV

Sponsor Role: collaborator

Huizhou Municipal Central Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bing Xu

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Xiamen University

Locations

Bing Xu

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Bing Xu, M.D.

Role: CONTACT

xubingzhangjian@126.com

+865922137255

Facility Contacts

Bing Xu

Role: primary

Other Identifiers

ChiCTR2200056657

Identifier Type: REGISTRY

Identifier Source: secondary_id

FXMH-AML-001

Identifier Type: -

Identifier Source: org_study_id