Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Launched by RUIJIN HOSPITAL · Oct 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with newly diagnosed Acute Myeloid Leukemia (AML), a type of blood cancer. The researchers want to see how safe and effective a combination of a standard chemotherapy treatment and two specific drugs, called venetoclax and gilteritinib, can be. Participants will first receive intensive chemotherapy to help reduce the cancer, and their response will be checked after a few days. If they respond well, they may receive one of the new drugs to further improve their treatment based on their specific genetic characteristics.

To be eligible for this trial, participants need to be between 18 and 59 years old and have a confirmed diagnosis of AML (not including certain types of leukemia). They should have a good performance status, meaning they are able to carry out daily activities with minimal assistance. Participants will be monitored closely throughout the trial, and the study is not yet recruiting new patients, so those interested will need to wait for further announcements. It's important for potential participants to understand the specific health requirements and to discuss any questions or concerns with their healthcare provider before considering joining the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Bone marrow morphology and immunology confirmed newly diagnosed AML patients (according to 2022 ICC criteria)
• • 2. Exclude patients with APL and CBF-AML (according to fusion genes and chromosomes)
• • 3. Performance status score 0-2 (ECOG score)
• • 4. Age 18\~59 years old
• • 5. Liver and kidney function: blood bilirubin ≤ 35 μmol/L, AST/ALT below 2 times the upper limit of normal, creatinine ≤ 150 μmol/L
• • 6. Normal cardiac function (EF ≥50%)
• • 7. Obtained informed consent signed by the patient or family member
• Exclusion Criteria:
• • 1. FAB classification is M3, or confirmed APL at the molecular level
• • 2. CBF-AML
• • 3. Patients who have already been treated
• • 4. Comfirmed central nervous system leukemia
• • 5. Allergy to any of the drugs involved in the protocol
• • 6. 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)
• • 7. 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
• • 8. 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)
• • 9. 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)
• • 10. 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
• • 11. Coagulopathy not associated with AML
• • 12. HIV infection, syphilis infection, HCV infection, active HBV infection (HBsAg positive, or HBsAg negative but HBcAb positive with HBV DNA \> 1.0 ×ULN)
• • 13. Other uncontrolled active infection (as judged by the investigator)
• • 14. Pregnant or lactating women
• • 15. Inability to understand or follow the study protocol
• • 16. Participation in other relevant clinical studies within 30 days (except diagnostic clinical studies)
• • 17. Patients who in the opinion of the investigator, are not suitable to participate in this study