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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06386302
• Other study ID #: CSIIT-A36
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: December 30, 2027

Study information

• Verified date: April 2024
• Source: Institute of Hematology & Blood Diseases Hospital, China
• Contact: Jianxiang Wang, Medical PhD
• Phone: 022-23909273
• Email: wangjx[@]ihcams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 184
• Est. completion date: December 30, 2027
• Est. primary completion date: December 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• AML
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Chidamide
30 mg/d orally twice-weekly
• Venetoclax
100 mg d1 200 mg d 2 400 mg d3-d28 Orally
• azacitidine
75 mg/m 2 /d subcutaneous injection or IV d1-d7

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Hematology & Blood Diseases Hospital, China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall response rate (ORR)	Overall response rate (ORR), including complete remission (Complete remission (CR), complete remission with incomplete blood count (CR with incomplete blood count recovery (CRi), morphological leukemia free state (MLFS), and partial remission (PR) as a percentage of the total number of patients participating in the efficacy analysis.	24months
Secondary	Overall survival (OS)	Overall survival (OS): defined as the number of days from the date of randomization to the date of death. Subjects who have not died will be censored on the last date they are known to be alive .	24months
Secondary	MRD response rate	Minimal residual disease (MRD)rate: defined as less than 0.1% remaining blasts per white blood cell, as measured by bone marrow examination. Other thresholds can also be explored and correlated with efficacy results. Subjects who are randomized but not assessed for MRD will be considered MRD response rate non-responders. The proportion of subjects achieving an MRD response (CR + CRi) was calculated.	24months