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

Part of paid clinical trials in Houston, Texas.

Sponsor
Joanna Yi
Study ID
NCT07059975
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Month - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Idarubicin Hydrochloride — DRUG
    Idarubicin is given in combination with fludarabine and cytarabine for Ida-FLA, and in combination with venetoclax and cytarabine for VIA.
  • Fludarabine — DRUG
    Fludarabine is given in combination with idarubicin and cytarabine for Ida-FLA.
  • Cytarabine (Ara-C) — DRUG
    Cytarabine is given in combination with other chemotherapy agents in every cycle and both arms.
  • Venetoclax — DRUG
    Venetoclax is given in combination with idarubicin and cytarabine for VIA.
  • Etoposide — DRUG
    Etoposide is given in combination with cytarabine for AE, as Intensification 1 for IR patients.
  • Asparaginase Erwinia Chrysanthemi (recombinant) — DRUG
    Rylaze is given in combination with cytarabine for Intensification 3 for IR patients.
  • Intrathecal triple — DRUG
    Methotrexate, hydrocortisone and cytarabine are combined into one preparation for intrathecal administration at multiple time points during treatment.
  • SOC — OTHER
    Low-Risk Patients will receive Texas childern's Hospital practice standard for de novo AML.

Study Details

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.

Key Dates

Start date
Oct 22, 2025
Status verified
Nov 2025
Primary completion
Oct 31, 2028
Completion
Aug 31, 2031

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intermediate Risk (IR) AML
    Patients will receive Ida-FLA as Induction 2, cytarabine/etoposide ("AE") as Intensification 1, VIA as Intensification 2, and Capizzi AraC as intensification 3.
  • Experimental: High risk (HR) AML
    Patients will receive Ida-FLA as Induction 2 and VIA as Intensification 1. These patients will then proceed on to a hematopoietic stem cell transplantation if an appropriate donor is found, otherwise will receive 2 more cycles of chemotherapy following the IR regimen.
  • Other: Low risk (LR)
    Low risk pediatric AML patients will receive standard of care chemotherapy but have the option to participate in correlative studies

Primary Outcome Measure

Tolerability rate of Ida-FLA [ Time Frame: From Day 1 of Ida-FLA through up to 50 days after completion of Ida-FLA ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Children's Cancer and Hematology CenterHoustonTexas77030
Joanna S Yi, MD
[email protected]
832-824-6699
Alexandra M Stevens, MD, PhD
[email protected]
832-824-4824

Find similar trials in Houston, TX

By condition
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By research site
Texas Children's Cancer and Hematology Center· Houston, TX

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