RecruitingEarly Phase 1NCT07059975

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

UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML: A Pilot Trial

Sponsor

Joanna Yi

Enrollment

36 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Myeloid Leukemia Pediatric AML

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.

Eligibility

Min Age: 1 MonthMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an updated treatment approach for pediatric and young adult patients with acute myeloid leukemia (AML), a serious blood cancer. It incorporates real-time disease monitoring using sensitive molecular tests to guide when and how intensively to treat — aiming to improve survival while reducing side effects. **You may be eligible if...** - You are between 1 month and 30 years of age - You have been newly diagnosed with AML or a related condition called myeloid sarcoma, confirmed by the WHO 2022 classification - Your bone marrow shows at least 20% leukemic (cancer) cells, or you have a specific genetic change associated with AML even at lower blast counts - You have not received prior treatment for AML (some limited exceptions apply) **You may NOT be eligible if...** - You have received prior therapy for AML (beyond emergency stabilization) - You have a different type of leukemia or blood cancer - You have AML secondary to prior cancer treatment (treatment-related AML) in some cases - You have serious organ problems that make intensive chemotherapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

DRUGIntrathecal triple

Methotrexate, hydrocortisone and cytarabine are combined into one preparation for intrathecal administration at multiple time points during treatment.

OTHERSOC

Low-Risk Patients will receive Texas childern's Hospital practice standard for de novo AML.

Locations(1)

Texas Children's Cancer and Hematology Center

Houston, Texas, United States

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NCT07059975

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