drugset / Trial / NCT07059975

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

NCT07059975

Phase 0 Recruiting 36 enrolled Joanna Yi Baylor College of Medicine · collab
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-10-22
Primary completion
2028-10
Completion
2031-08

Drugs

EvaluationDrugModalityDoseRoute
Background Cytarabine Small molecule
Subject Fludarabine Small molecule
Subject Idarubicin Small molecule
Subject Venetoclax Small molecule
Background Asparaginase Erwinia chrysanthemi Protein / enzyme biologic
Background Cytarabine Small molecule Intrathecal
Background Etoposide Small molecule
Background Hydrocortisone Other / unclassified Intrathecal
Background Methotrexate Small molecule Intrathecal