Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

NCT ID: NCT06386302

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-05
• Study Completion Date: 2027-12-30

Brief Summary

To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy.

Conditions

AML; Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chidamide combined with venetoclax, azacitidine group

Chidamide (C): 30 mg/d orally on d1, 4, 8, 11 or 10 mg QD, d1-d14, adjusted according to patient tolerance Azacitidine (A): 75 mg/m 2 /d subcutaneous injection d1-d7 Venetoclax (V): 100 mg d1 200 mg d 2 400 mg d3-d28 Orally

A treatment cycle is 28 days , and subjects will continue to receive treatment allocation according to the investigator's assessment until documented disease progression, intolerable toxicity, withdrawal of consent, or the subject meets other conditions for terminating treatment. Program Standards (whichever occurs first).

Group Type: EXPERIMENTAL

Chidamide

Intervention Type: DRUG

30 mg/d orally twice-weekly

Venetoclax

Intervention Type: DRUG

100 mg d1 200 mg d 2 400 mg d3-d28 Orally

azacitidine

Intervention Type: DRUG

75 mg/m 2 /d subcutaneous injection or IV d1-d7

venetoclax, azacitidine group

azacitidine: 75 mg/m 2 /d subcutaneous injection d1-d7 Venetoclax: 100 mg day 1, 200 mg day 2, 400 mg day 3-d28 orally A treatment cycle is 28 days , and subjects will continue to receive treatment allocation according to the investigator's assessment until documented disease progression, intolerable toxicity, withdrawal of consent, or the subject meets other conditions for terminating treatment. Program Standards (whichever occurs first).

Group Type: ACTIVE_COMPARATOR

Venetoclax

Intervention Type: DRUG

100 mg d1 200 mg d 2 400 mg d3-d28 Orally

azacitidine

Intervention Type: DRUG

75 mg/m 2 /d subcutaneous injection or IV d1-d7

Interventions

Chidamide

30 mg/d orally twice-weekly

Intervention Type: DRUG

Venetoclax

100 mg d1 200 mg d 2 400 mg d3-d28 Orally

Intervention Type: DRUG

azacitidine

75 mg/m 2 /d subcutaneous injection or IV d1-d7

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• （1）Age ≥18 years old, no gender limit ;
• （2）be diagnosed with AML (non-M3) according to WHO 2016 standards;
• （3）No previous treatment;
• （4）Ineligible for intensive chemotherapy based on the following definitions: ≥75 years of age or 18 to 74 years of age with at least one of the following comorbidities: Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3 A history of cardiac disease such as congestive heart failure Treatment is required, or ejection fraction ≤ 50%, or chronic stable angina, diffusing capacity of lung for carbon monoxide (DLCO) ≤ 65%, or forced expiratory volume in first second (FEV1) ≤ 65%, creatinine clearance ≥ 30 mL/min to < 45 mL/min, moderate hepatic impairment, total bilirubin > 1.5 to ≤ 3.0 × ULN, other comorbidities that are not suitable for intensive chemotherapy in the physician's judgment.
• （5）Subjects must have an ECOG performance status score of: 0 to 2 for subjects aged ≥ 75 years or 0 to 3 for subjects aged ≥ 18 to 74 years.
• （6）Other comorbidities that are not suitable for intensive chemotherapy in the doctor's judgment;
• （7）Expected survival time ≥3 months;
• （8）Have the ability to understand and be willing to sign the informed consent form for this study.

Exclusion Criteria

• (1) Combined with other malignant tumors
• (2) Have ever received treatment with chidamide and / or venetoclax or azacitidine;
• (3) The risk is assessed as low risk according to the NCCN 2022 guidelines [t(8;21)(q22;q22.1);RUNX1-RUNX1T1, inv(16)(p13.1q22) or t(16;16 )(p13.1;q22);CBFB-MYH11 ] ;
• (4) The subject is known to have AML central nervous system (CNS) infiltration;
• (5) Have undergone cardiac angioplasty or stent placement within 12 months before signing the informed consent form , or have a history of myocardial infarction, unstable angina, or other clinically significant heart disease;
• (6 ) Active infections (including bacterial, fungal or viral infections) and organ bleeding that cannot be controlled clinically;
• (7) Pregnant or lactating women;
• (8) Participated in any other clinical research within 3 months before signing the informed consent form ;
• (9 ) The researcher believes that it is not suitable to participate in this study;

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

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianxiang Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Locations

Blood Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianxiang Wang, Medical PhD

Role: CONTACT

wangjx@ihcams.ac.cn

022-23909273

Facility Contacts

hui wei, MD

Role: primary

weihui@ihcams.ac.cn

86-13132507161

Other Identifiers

IIT2023074

Identifier Type: -

Identifier Source: org_study_id