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Trial Title:
Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia
NCT ID:
NCT06386302
Condition:
AML
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Azacitidine
Venetoclax
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide
Description:
30 mg/d orally twice-weekly
Arm group label:
Chidamide combined with venetoclax, azacitidine group
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
100 mg d1 200 mg d 2 400 mg d3-d28 Orally
Arm group label:
Chidamide combined with venetoclax, azacitidine group
Arm group label:
venetoclax, azacitidine group
Intervention type:
Drug
Intervention name:
azacitidine
Description:
75 mg/m 2 /d subcutaneous injection or IV d1-d7
Arm group label:
Chidamide combined with venetoclax, azacitidine group
Arm group label:
venetoclax, azacitidine group
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.
Criteria for 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Blood Hospital
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Contact:
Last name:
hui wei, MD
Phone:
86-13132507161
Email:
weihui@ihcams.ac.cn
Start date:
August 5, 2024
Completion date:
December 30, 2027
Lead sponsor:
Agency:
Institute of Hematology & Blood Diseases Hospital, China
Agency class:
Other
Source:
Institute of Hematology & Blood Diseases Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06386302
