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New treatment option for AML
Official title Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06386302
What this study is testing
What is Chidamide?
Chidamide is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for aml.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- （5）people must have an ECOG performance status score of: 0 to 2 for people aged ≥ 75 years or 0 to 3 for people aged ≥ 18 to 74 years.
You likely can't join 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...
- (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...
- (6 ) Active infections (including bacterial, fungal or viral infections) and organ bleeding that cannot be controlled clinically;
See the full eligibility 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)...
- （5）people must have an ECOG performance status score of: 0 to 2 for people aged ≥ 75 years or 0 to 3 for people 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.
- (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...
- (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;
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.