Venetoclax and Azacitidine Combined With Chidamide (VAC) for the Treatment of Newly Diagnosed Acute Monocytic Leukemia

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Sep 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment combination of three medications—venetoclax, azacitidine, and chidamide—for patients with newly diagnosed acute monocytic leukemia, a type of blood cancer. This trial is specifically looking for patients who are unable to undergo intensive chemotherapy due to their age or other health issues. To participate, candidates should be at least 60 years old or between 18 and 59 with certain health conditions that make intensive treatment risky. Patients must also have a confirmed diagnosis of acute monocytic leukemia and a life expectancy of at least 12 weeks.

Participants in this trial will receive the combination of medications and will be monitored for how effective the treatment is and any side effects they might experience. It’s important for potential participants to know that they must not have had any prior chemotherapy or radiation treatment and should not be pregnant or breastfeeding. Additionally, they will need to agree to use effective birth control if they are of childbearing age. This trial offers a chance to explore a new treatment option for those who need it most, and interested individuals should talk to their healthcare provider to see if they qualify.

Gender

ALL

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