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

NCT06386302 | Recruiting

• 1 other identifier: IIT2023074
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Composite complete remission rate

  Composite complete remission rate after 2 cycles of treatment \[Complete remission, CR) + complete remission with incomplete blood count (CR with incomplete blood count recovery, CRi); CR + CRi \]

  2 months

Secondary Outcomes (3)

• Overall response rate (ORR)

  24months

• Overall survival (OS)

  24months

• MRD response rate

  24months

Study Arms (2)

Chidamide combined with venetoclax, azacitidine group

EXPERIMENTAL

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).

Drug: Chidamide; Drug: Venetoclax; Drug: azacitidine

venetoclax, azacitidine group

ACTIVE COMPARATOR

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).

Drug: Venetoclax; Drug: azacitidine

Interventions

Chidamide DRUG

30 mg/d orally twice-weekly

Chidamide combined with venetoclax, azacitidine group

Venetoclax DRUG

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

Chidamide combined with venetoclax, azacitidine group; venetoclax, azacitidine group

azacitidine DRUG

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

Chidamide combined with venetoclax, azacitidine group; venetoclax, azacitidine group

Eligibility Criteria

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

You may qualify if:

• （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.

You may not qualify if:

• (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;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Blood Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

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

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Jianxiang Wang, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianxiang Wang, Medical PhD

CONTACT

022-23909273; wangjx@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 26, 2024
• Study Start: August 5, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: August 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)