a New Treatment of Newly Diagnosed IDH1 Mutation Acute Myeloid Leukemia
This is a single arm, open-label, multicenter clinical trial to evaluate the efficacy and safety of ivosidenib+venetoclax+ azacitidine in adult Chinese subjects with newly diagnosed IDH1m AML.A total of approximately 42 China Nationwide subjects with newly diagnosed IDH1m AML will participate in the study.The primary e
| Condition(s) | Acute Myeloid Leukemia, IDH1 Gene Mutation, Ivosidenib |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | This is a single arm, open-label, multicenter clinical trial to evaluate the efficacy and safety of ivosidenib+venetoclax+ azacitidine in adult Chinese subjects with newly diagnosed IDH1m AML.A total of approximately 42 China Nationwide subjects with newly diagnosed IDH1m AML will participate in the study.The primary endpoint of the study is the complete remission(CR) + CR with partial hematologic recovery(CRh) rate, and the key secondary endpoints are CR rate,event-free survival (EFS),overall survival (OS),the objective response rate (ORR). |
| Who can participate | Inclusion Criteria: 1. Be ≥18 years of age 2. Have previously untreated AML, defined according to World Health Organization criteria. Subjects with extramedullary disease alone (ie, no detectable bone marrow and no detectable peripheral blood AML) are not eligible for the study. 3. Have an IDHl mutation resulting in an R132C, R132G, R132H, R132L, or R132S substitution. 4. Have an ECOG PS score of 0 to 2. 5. Have adequate hepatic function, as evidenced by: * Serum total bilirubin ≤2 × ULN, unless considered to be due to Gilbert's disease or underlying leukemia, where it must be \<3 x ULN. * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3.0 × ULN, unless considered to be due to underlying leukemia. 6. Have adequate renal function, as eviden |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital of Soochow University |
| Locations | Suzhou, Jiangsu, China |
| Start date | 2025-06-01 |
| NCT ID | NCT07007949 |
| Official listing | https://clinicaltrials.gov/study/NCT07007949 |