Combination treatment for newly diagnosed acute myeloid leukemia

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

This study is testing a new combination treatment for adults with newly diagnosed acute myeloid leukemia who can't have standard chemotherapy to see if it can help them safely and effectively.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 184 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06386302 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility, effectiveness, and safety of a combination treatment using chidamide, venetoclax, and azacitidine for patients with newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy. The trial focuses on individuals aged 18 and older, specifically targeting those with certain comorbidities or age-related factors that make them ineligible for standard treatment options. By assessing the outcomes of this combination therapy, the study aims to provide a viable alternative for patients with limited treatment options.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with non-M3 AML who are ineligible for intensive chemotherapy due to age or comorbidities.

Not a fit: Patients who have previously received treatment for AML or those with M3 subtype of AML may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with acute myeloid leukemia who cannot undergo intensive chemotherapy.

How similar studies have performed: While this approach is innovative, similar studies exploring combination therapies for AML have shown promising results, indicating potential for success.

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;

Where this trial is running

Tianjin, Tianjin Municipality

• Blood Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Jianxiang Wang, MD — Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
• Study coordinator: Jianxiang Wang, Medical PhD

Conditions: AML, Acute Myeloid Leukemia