This research study investigates the tolerability of substituting two cycles of chemotherapy into the standard pediatric acute myeloid leukemia (AML) chemotherapy treatment regimen for patients with newly diagnosed AML at intermediate-risk (IR) and high-risk (HR) of relapse. The goal is to achieve similar or better survival with chemotherapy cycles that are intensive but less likely to cause long-term complications. Patients will enroll on this trial at the end of their first induction cycle.
The two cycles to be substituted are:
"Ida-FLA" (idarubicin+fludarabine/cytarabine) as Induction 2
"VIA" (venetoclax+idarubicin+cytarabine) as Intensification 1 of the HR treatment regimen, and Intensification 2 of the IR treatment backbone.
Researchers will evaluate side effects and outcomes for up to three years after enrollment.
Participants will also have the opportunity to participate in optional research studies including patient surveys and blood and bone marrow sample testing.
Eligibility
Ages 1 month to 30 years
Diagnosed with AML or myeloid sarcoma
Must have completed Induction 1 chemotherapy (DA10+GO)
No FLT3-ITD mutation
Performance status score above 40 (Karnofsky/Lansky)
Adequate kidney, liver, heart, and blood clotting function
Specific genetic markers may be required (e.g., RUNX1::RUNX1T1, CBFB::MYH11, KMT2A rearrangement, etc.)
Detailed inclusion and exclusion criteria are listed on clinicaltrials.gov
To inquire about this trial, please visit our patient referral page:
