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Trial Title:
Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia
NCT ID:
NCT05566054
Condition:
Acute Monocytic Leukemia
Newly Diagnosed
Conditions: Official terms:
Leukemia
Leukemia, Monocytic, Acute
Azacitidine
Venetoclax
Conditions: Keywords:
Chidamide
Azacitidine
Venetoclax
Study type:
Interventional
Study phase:
Phase 2
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:
Chidamide 10mg orally daily for 7 days (d1-d7)
Arm group label:
VAC group
Intervention type:
Drug
Intervention name:
Azacitidine
Description:
azacytidine 75mg/m2 daily for 7 days (d1-d7)
Arm group label:
VA group
Arm group label:
VAC group
Intervention type:
Drug
Intervention name:
Venetoclax
Description:
Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-28)
Arm group label:
VA group
Arm group label:
VAC group
Summary:
This study is to investigate the therapeutic efficacy and side effect of venetoclax,
azacytidine combined with chidamide for newly diagnosed acute monocytic leukemia patients
that are ineligible for intensive chemotherapy
Detailed description:
Acute myeloid leukemia (AML) is one of the most aggressive blood cancers, with a very low
survival rate and few options for patients who are unable to undergo intensive
chemotherapy. Venetoclax in combination with hypomethylation agents or cytarabine has
been approved by the Food and Drug Administration (FDA) for the treatment of patients
with newly diagnosed AML unfit for intensive chemotherapy. However, resistance to
venetoclax can be acquired through the upregulation of anti-apoptotic proteins in the
BCL2 family, such as myeloid cell leukaemia 1 (MCL1). MCL1 plays a critical role in cell
apoptosis regulation and high expression of MCL1 is observed in acute monocytic leukemia
(AML-M5) . Chidamide, a newly designed selective histone deacetylase inhibitor, resulted
in a decrease in the protein level of MCL1. This study is to investigate the therapeutic
efficacy and side effect of venetoclax, azacytidine combined with chidamide for newly
diagnosed AML-M5 patients that are ineligible for intensive chemotherapy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Confirmation of acute monocytic leukemia( AML-M5) diagnosis by the
French-American-British (FAB) Classification and/or characterized for expression of
monocytic and myeloid differentiation markers, have a projected life expectancy of at
least 12 weeks, previously untreated, and ineligible for treatment with intensive
chemotherapy.
Patients must be considered ineligible for induction therapy defined by the following:
1. >= 60 years of age
2. >=18 to 59years of age with at least one of the following comorbidities:
Any other comorbidity that the physician judges to be incompatible with intensive
chemotherapy:
(A)Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.
(B)Cardiac history of congestive heart failure requiring treatment or ejection
fraction <= 50% or chronic stable angina.
(C)Diffusing capacity of the lung for carbon monoxide (DLCO) <= 65% or forced
expiratory volume during the first second (FEV1) <= 65%.
(D)Creatinine clearance >= 30 mL/min to < 45 mL/min. (E)Moderate hepatic impairment
with total bilirubin > 1.5 to <= 3.0 × upper limit of normal (ULN).
3. Must meet the laboratory requirements per the protocol.
4. Female participant must not be pregnant or breastfeeding and is not considering
becoming pregnant or donating eggs during the study or for approximately 90 days
after the last dose of study drug.
5. Female participants of childbearing potential must agree to use at least 1
protocol-specified method of birth control and male participants, if sexually active
with female partner(s) of childbearing potential, must agree to practice the
protocol-specified contraception.
6. Did not receive radiotherapy, chemotherapy, targeted therapy or hematopoietic stem
cell transplantation within 4 weeks before enrollment;
7. Other comorbidities that are not suitable for intensive chemotherapy;
8. The patient refused to receive intensive chemotherapy;
9. Ability to understand and willing to sign the informed consent for this trial.
Exclusion Criteria:
1. Patients who are allergic to the study drug or drugs with similar chemical
structures
2. Pregnant or lactating women, and women of childbearing age who do not want to
practice effective methods of contraception
3. Active infection
4. Active bleeding
5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a
medical history within one year before enrollment
6. Patients with mental disorders or other conditions whereby informed consent cannot
be obtained and where the requirements of the study treatment and procedures cannot
be met
7. Liver function abnormalities (total bilirubin > 1.5 times the upper limit of the
normal range, ALT/AST > 2.5 times the upper limit of the normal range or patients
with liver involvement whose ALT/AST > 1.5 times the upper limit of the normal
range), or renal anomalies (serum creatinine > 1.5 times the upper limit of the
normal value)
8. Patients with a history of clinically significant QTc interval prolongation (male >
450 ms; female > 470 ms), ventricular heart tachycardia and atrial fibrillation,
II-degree heart block, myocardial infarction attack within one year before
enrollment, and congestive heart failure, and patients with coronary heart disease
who have clinical symptoms and requiring drug treatment
9. Urgery on the main organs within the past six weeks
10. Drug abuse or long-term alcohol abuse that would affect the evaluation results
11. Patients who have received organ transplants (excepting bone marrow transplantation)
12. Patients not suitable for the study according to the investigator's assessment
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Sheng-Li Xue, M.D.
Phone:
+86 512 6778 1139
Email:
slxue@suda.edu.cn
Start date:
March 1, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
The First Affiliated Hospital of Soochow University
Agency class:
Other
Collaborator:
Agency:
Jining Medical University
Agency class:
Other
Collaborator:
Agency:
The Second People's Hospital of Huai'an
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Bengbu Medical College
Agency class:
Other
Collaborator:
Agency:
Northern Jiangsu People's Hospital
Agency class:
Other
Collaborator:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Collaborator:
Agency:
Suzhou Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Taizhou University
Agency class:
Other
Source:
The First Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05566054
