About this trial
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 criteria
Qualifiers
≥ 20% bone marrow blasts
t(8;21)(q22;q22.1) RUNX1::RUNX1T1
inv(16)(p13.1q22) or t(16;16)(p13.1;q22) CBFB::MYH11
Translocation involving 11q23.3 KMT2A rearrangement
Disqualifiers
Therapy-related AML
Mixed phenotype acute leukemia
Acute promyelocytic leukemia
AML with FLT3 internal tandem duplication (FLT3-ITD)
Trial design
Treatments tested in this trial
- Idarubicin Hydrochloride
- Fludarabine
- Cytarabine (Ara-C)
- Venetoclax
- Etoposide
- Asparaginase Erwinia Chrysanthemi (recombinant)
- Intrathecal triple
- SOC
Treatment groups
Sponsors and collaborators
Joanna Yi
Lead sponsor
Baylor College of Medicine
Sponsor institution
Baylor College of Medicine
Collaborator