🏛️ Verified NIH Record • Updated 2026-08-21

UPDATE AML: UPdated Disease Monitoring And Treatment for Enhanced Outcomes for Pediatric AML (NCT07059975)

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

🟢 Recruiting Early Phase1 💊 Investigational Drug / Biologic Sponsor: Baylor College of Medicine

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (29 items) and avoid the listed exclusions (18 items).

Location: Texas Children's Cancer and Hematology Center — Houston, Texas

Age range: 1 Month to 30 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Patients with the following constitutional conditions are not eligible:
  • Fanconi anemia
  • Schwachman Diamond Syndrome
  • Telomere Disorders
  • Patients with constitutional trisomy 21 or with constitutional mosaicism of trisomy 21
  • Germline predispositions known, or suspected by the treating physician, to increase risk of toxicity with AML therapy
  • Therapy-related AML
  • Patients with any of the following oncologic diagnoses are not eligible:
  • Any concurrent malignancy
  • Juvenile myelomonocytic leukemia
  • Philadelphia chromosome positive AML

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

  • Texas Children's Cancer and Hematology Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: (832) 824-6699

Email: jsyi@texaschildrens.org

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
  • 💵 Compensation indicated: Newly diagnosed patients will receive standard Induction 1 treatment off study.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗