Clinical trial NCT06386302: Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia
Official title: A Multicenter, Randomized, Controlled Clinical Trial of Chidamide Combined With Venetoclax and Azacitidine in the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML) Who Are Not Suitable for Intensive Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: AML
Acute Myeloid Leukemia
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2024-04-26
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Composite complete remission rate
timeFrame: 2 months
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: 24months
measure: Overall survival (OS)
timeFrame: 24months
measure: MRD response rate
timeFrame: 24months
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Blood Hospital
state: Tianjin
Study officials:
affiliation: Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
name: Jianxiang Wang, MD
role: PRINCIPAL_INVESTIGATOR
References: