UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML: A Pilot Trial
Joanna Yi
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.
Description
UPDATE AML is a research study that investigates the tolerability of substituting two cycles of chemotherapy into the standard pediatric acute myeloid leukemia (AML) chemotherapy treatment regimen for patients at intermediate-risk (IR) and high-risk (HR) of the leukemia coming back ("relapse"). Newly diagnosed patients will receive standard Induction 1 treatment off study. If they do not have a FLT3-ITD mutation, they will be eligible to complete treatment on the UPDATE AML study. Patients considered Low Risk will receive the standard treatments outside of the UPDATE AML trial but will be elig…
Eligibility
- Age range
- 0–30 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \- Age Patients ≥ 1 months old to ≤ 30 years old are eligible Patients must be diagnosed with AML or myeloid sarcoma according to the 2022 WHO classification with or without extramedullary disease. Patients with AML must have 1 of the following at initial diagnosis: 1. ≥ 20% bone marrow blasts • In cases where extensive fibrosis may result in a dry tap, blast count can be obtained from touch imprints or estimated from an adequate bone marrow core biopsy. 2. \< 20% bone marrow blasts with one or more of the genetic abnormalities below: * t(8;21)(q22;q22.1) RUNX1::…
Interventions
- DrugIdarubicin Hydrochloride
Idarubicin is given in combination with fludarabine and cytarabine for Ida-FLA, and in combination with venetoclax and cytarabine for VIA.
- DrugFludarabine
Fludarabine is given in combination with idarubicin and cytarabine for Ida-FLA.
- DrugCytarabine (Ara-C)
Cytarabine is given in combination with other chemotherapy agents in every cycle and both arms.
- DrugVenetoclax
Venetoclax is given in combination with idarubicin and cytarabine for VIA.
- DrugEtoposide
Etoposide is given in combination with cytarabine for AE, as Intensification 1 for IR patients.
- DrugAsparaginase Erwinia Chrysanthemi (recombinant)
Rylaze is given in combination with cytarabine for Intensification 3 for IR patients.
Location
- Texas Children's Cancer and Hematology CenterHouston, Texas