Actively Recruiting
UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML
Led by Joanna Yi · Updated on 2025-11-04
36
Participants Needed
1
Research Sites
301 weeks
Total Duration
On this page
Sponsors
J
Joanna Yi
Lead Sponsor
B
Baylor College of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 1 month to 30 years old
- Diagnosed with AML or myeloid sarcoma as defined by 2022 WHO criteria
- AML diagnosis includes either 20% bone marrow blasts or specific genetic abnormalities if blasts <20%
- Alternatively, diagnosis by blood counts or biopsy-proven myeloid sarcoma
- Received standard induction 1 chemotherapy (DA10+GO or TXCH practice standard)
- Karnofsky/Lansky performance score above 40
- Adequate kidney, liver, coagulation, and heart function within specified laboratory limits
- Informed consent and assent obtained according to institutional guidelines
You will not qualify if you...
- Presence of Fanconi anemia, Schwachman Diamond Syndrome, telomere disorders, or constitutional trisomy 21
- Known or suspected germline predisposition increasing AML therapy toxicity
- Therapy-related AML
- Concurrent malignancies including juvenile myelomonocytic leukemia, Philadelphia chromosome positive AML, mixed phenotype acute leukemia, acute promyelocytic leukemia, or AML with FLT3-ITD
- Pregnant or breastfeeding females
- Patients of reproductive potential not using effective contraception
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Texas Children's Cancer and Hematology Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
J
Joanna S Yi, MD
CONTACT
A
Alexandra M Stevens, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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