36
Participants
Start Date
October 1, 2025
Primary Completion Date
October 31, 2028
Study Completion Date
August 31, 2031
Idarubicin Hydrochloride
Idarubicin is given in combination with fludarabine and cytarabine for Ida-FLA, and in combination with venetoclax and cytarabine for VIA.
Fludarabine
Fludarabine is given in combination with idarubicin and cytarabine for Ida-FLA.
Cytarabine (Ara-C)
Cytarabine is given in combination with other chemotherapy agents in every cycle and both arms.
Venetoclax
Venetoclax is given in combination with idarubicin and cytarabine for VIA.
Etoposide
Etoposide is given in combination with cytarabine for AE, as Intensification 1 for IR patients.
Asparaginase Erwinia Chrysanthemi (recombinant)
Rylaze is given in combination with cytarabine for Intensification 3 for IR patients.
Intrathecal triple
Methotrexate, hydrocortisone and cytarabine are combined into one preparation for intrathecal administration at multiple time points during treatment.
SOC
Low-Risk Patients will receive Texas childern's Hospital practice standard for de novo AML.
Texas Children's Cancer and Hematology Center, Houston
Baylor College of Medicine
OTHER
Joanna Yi
OTHER