Newly Diagnosed Clinical Trial
Official title:
A Multicenter, Randomized, Controlled Clinical Trial of Venetoclax, Azacytidine Combined With Chidamide for the Treatment of Newly Diagnosed Acute Monocytic Leukemia Patients That Are Ineligible for Intensive Chemotherapy
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
Status | Recruiting |
Enrollment | 92 |
Est. completion date | September 30, 2025 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | The First Affliated Hospital of Soochow University | Suzhou | Jiangsu |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Soochow University | Affiliated Hospital of Nantong University, First Affiliated Hospital Bengbu Medical College, Jining Medical University, Northern Jiangsu Province People's Hospital, Suzhou Hospital of Traditional Chinese Medicine, Taizhou University, The Second People's Hospital of Huai'an |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite Complete Remission Rate | The composite complete remission rate(complete remission plus complete remission with incomplete blood cell count recovery) | At the end of Cycle 1 or 2 (each cycle is 28 days) | |
Primary | Overall response rate (ORR) | The overall response (completed remission without minimal residual disease, completed remission with incomplete blood count recovery, morphologic leukemia-free state and partial remission) | At the end of Cycle 1 or 2 (each cycle is 28 days) | |
Secondary | Duration of Response (DOR) | It is measured the time from initial response to subsequent disease progression or relapse | 1 year | |
Secondary | Overall Survival (OS) | It is measured from the time of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive | 1 year | |
Secondary | Progression-Free Survival (PFS) | It is measured from the time from randomization to progression or death | 1 year | |
Secondary | Adverse reactions in hematology | Record of adverse events in hematological system during and after VEN+AZA+Chidamide regimen induction (agranulocytosis days, PLT/RBC transfusion units) | At the end of Cycle 1 (each cycle is 28 days) | |
Secondary | Nonhematological adverse reactions | Record of adverse events in other organs or systmes during and after VEN+AZA+Chidamide regimen induction (infection and organ injury) | At the end of Cycle 1 (each cycle is 28 days) |
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