UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age1-30
SponsorJoanna Yi

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

36 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Joanna Yi

Lead sponsor

Baylor College of Medicine

Sponsor institution

Baylor College of Medicine

Collaborator