Multicenter Randomized Trial of Intermediate-Dose HAD Regimen for CEBPA Double-Mutated Acute Myeloid Leukemia

What this Trial Is About

Researchers are investigating treatments for acute myeloid leukemia (AML) with a specific genetic mutation called CEBPA double-mutated AML, which is common in China. This trial aims to compare the effectiveness of an intermediate-dose HAD chemotherapy regimen to the standard "3+7" induction therapy. The study is designed as a multi-center, randomized, controlled clinical trial to confirm if the intermediate-dose HAD regimen offers better outcomes for patients with this type of AML. Participants diagnosed with CEBPA double-mutated AML are randomly assigned to receive either the intermediate-dose HAD regimen, which includes homoharringtonine, cytarabine, and daunorubicin, or the conventional 3+7 induction regimen using cytarabine combined with daunorubicin or idarubicin. If patients reach complete remission after induction, they receive three courses of high-dose cytarabine for consolidation. Hematopoietic stem cell transplantation is recommended for those with persistent minimal residual disease. Patients not achieving remission after induction receive reinduction therapy with the IAC regimen, and those still not in remission after reinduction are removed from the study. Throughout the trial, participants are closely monitored with various laboratory tests including liver and kidney function, heart function via echocardiography, and other clinical assessments to ensure safety and treatment response. The main outcome measured is event-free survival up to two years after the last patient enrolls. This detailed follow-up helps researchers evaluate the long-term effects and benefits of the treatment regimens under study.

Intermediate-dose HAD Regimen for CEBPA Double-mutated AML