Adjusted chemotherapy with venetoclax for newly diagnosed acute myeloid leukemia in younger adults

Trial details

Who runs it

Ruijin Hospital

Trial code

NCT06652685

Record updated

22 October 2024

Original description

This study aims to investigate the safety and efficacy of drug "X" in combination with intensive chemotherapy in subjects with newly diagnosed AML (excluding APL and CBF-AML). "X" drugs included BCL-2 inhibitor venetoclax and FLT3 inhibitor Gilteritinib.Read full original descriptionShow less

Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Young Treatment-naive Acute Myeloid Leukemia: a Multicenter, Phase II Study

This study aims to investigate the safety and efficacy of drug "X" in combination with intensive chemotherapy in subjects with newly diagnosed AML (excluding APL and CBF-AML). "X" drugs included BCL-2 inhibitor venetoclax and FLT3 inhibitor Gilteritinib.

Subjects will receive standard intensive chemotherapy during induction and consolidation. Early induction response will be evaluated according to the results of peripheral blood blast clearance rate on the fifth day after induction therapy (D5-PBCR). Venetoclax will be added in D5-PBCR positive subjects. For subjects with FLT3 mutations, Gilteritinib will be combined.

Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet recommendations (ELN risk) and MRD status to receive specific consolidation therapy after the induction therapy.

Inclusion: Bone marrow morphology and immunology confirmed newly diagnosed AML patients (according to 2022 ICC criteria); Exclude patients with APL and CBF-AML (according to fusion genes and chromosomes); Performance status score 0-2 (ECOG score); Age 18~59 years old; Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal, creatinine ≤ 150 μmol/L; Normal cardiac function (EF ≥50%); Obtained informed consent signed by the patient or family member.

Exclusion: Previous or present concomitant malignancies (except for basal cell carcinoma of the skin that have been effectively controlled as non-melanoma, carcinoma in situ of the breast/cervix, and other malignancies that have not been effectively controlled for more than 6 months, and patients who have been receiving long-term non-chemotherapy treatments such as hormonal therapy); Allergy to any of the drugs involved in the protocol; Medical condition or organ system dysfunction that precludes the inability to swallow capsules or tablets, or has a disease that significantly affects gastrointestinal function and/or inhibits small bowel absorption (including malabsorption syndrome, small bowel resection, or poorly controlled inflammatory bowel disease); Other uncontrolled active infection (as judged by the investigator); Cardiac function and disease consistent with one of the following: a) long QTc syndrome or QTc interval >480 ms; b) second- or third-degree atrioventricular block; Severe, uncontrolled cardiac arrhythmias requiring medication; c) United States New York College of Cardiology Grade ≥ III; d) Ventricular ejection fraction (LVEF) less than 50%; e) History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, history of clinically severe pericardial disease, or ECG evidence of acute ischemic or active conduction abnormalities within 6 months prior to recruitment; Significant abnormalities in liver and kidney function (serum bilirubin, aspartate aminotransferase, alanine aminotransferase or serum creatinine more than 2 times the upper limit of normal reference values; Excluded from AML-related as judged by the investigator); Patients who have previously used other drugs for the treatment of AML (except hydroxyurea and cytarabine for cell count control), including but not limited to BCL2, FLT3, IDH1, IDH2 inhibitors, or other drugs in clinical trials; HIV infection, syphilis infection, HCV infection, active HBV infection (HBsAg positive, or HBsAg negative but HBcAb positive with HBV DNA > 1.0 ×ULN); FAB classification is M3, or confirmed APL at the molecular level; CBF-AML; Patients who have already been treated; Comfirmed central nervous system leukemia; Coagulopathy not associated with AML; Pregnant or lactating women; Inability to understand or follow the study protocol; Participation in other relevant clinical studies within 30 days (except diagnostic clinical studies); Patients who in the opinion of the investigator, are not suitable to participate in this study.

ClinicalTrials.gov NCT06652685