Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML) (NCT05183035)

🧪 Interventions in This Study

• Fludarabine (DRUG)
• Cytarabine (DRUG)
• Gemtuzumab Ozogamicin (DRUG)
• Azacitidine (DRUG)
• Venetoclax (DRUG)

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).

1. Participants must have enrolled on APAL2020SC, NCT Number: NCT04726241 prior to enrollment on ITCC-101/APAL2020D. (This is only applicable for participants in USA/Canada/Australia/New Zealand sites/Blood Cancer United territory).
2. Participants must be \>28 days of age and \< 22 years of age at enrollment.
3. Participants must have one of the following:
4. Children, adolescents, and young adults with AML without demonstrated FLT3/internal tandem duplication (ITD) mutation. Ideally, the status of the mutation needs to be proven in the current relapse. Nevertheless, patients with previous FLT3/ITD negative test from prior lines can be included based on local results in order to not delay the start of treatment.
5. And participants must have AML which is either:
6. Untreated second relapse, in participants who are sufficiently fit to undergo another round of intensive chemotherapy, or
7. Untreated first relapse, in participants who cannot tolerate additional anthracycline containing chemotherapy per investigator discretion.
8. Participants must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2 (≥ 50% Lansky or Karnofsky score).
9. Participants must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to start of protocol treatment:
10. Cytotoxic chemotherapy: Must not have received cytotoxic chemotherapy within 14 days prior to start of protocol treatment, except for corticosteroids, low dose cytarabine or hydroxyurea that can be given up to 24 hours prior to start of protocol treatment.
11. Intrathecal cytotoxic therapy: No wash-out time is required for participants having received any combination of intrathecal cytarabine, methotrexate, and/or hydrocortisone.
12. Antibodies: ≥ 21 days must have elapsed from infusion of last dose of an antibody-drug conjugate before start of protocol treatment. For unmodified antibodies or T cell engaging antibodies, 2 half-lives must have elapsed before start of protocol treatment. Any toxicity related to prior antibody therapy must be recovered to Grade ≤ 1.

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

📍 All Participating Trial Locations (90 Sites)

Showing the first 25 of 90 sites.

• Phoenix Children's Hospital — Phoenix, Arizona
• Arkansas Children's Hospital — Little Rock, Arkansas
• MemorialCare Miller Children's and Women's Hospital Long Beach — Long Beach, California
• Children's Hospital of Orange County Main Campus - Orange — Orange, California
• Benioff Children's Hospital - Mission Bay — San Francisco, California
• Children's Hospital Colorado — Aurora, Colorado
• Yale University — New Haven, Connecticut
• Nemours Alfred I. Dupont Hospital for Children — Wilmington, Delaware
• Children's National - Main Hospital — Washington D.C., District of Columbia
• Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida
• University of Florida Health Shands Children's Hospital — Gainesville, Florida
• Nemours Children's Specialty Care Jacksonville — Jacksonville, Florida
• Nemours Children's Hospital - Orlando — Orlando, Florida
• Saint Joseph's Hospital - Tampa — Tampa, Florida
• Children's Healthcare of Atlanta — Atlanta, Georgia
• Kapi'olani Medical Center for Women and Children — Honolulu, Hawaii
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
• Comer Children's Hospital — Chicago, Illinois
• Indiana University School of Medicine — Indianapolis, Indiana
• University of Iowa Stead Family Children's Hospital — Iowa City, Iowa
• Norton Children's Hospital — Louisville, Kentucky
• Dana-Farber Cancer Institute — Boston, Massachusetts
• C.S. Mott Children's Hospital — Ann Arbor, Michigan
• Children's Hospital of Michigan — Detroit, Michigan
• Masonic Cancer Center — Minneapolis, Minnesota

📞 Contact the Study Coordinator

Phone: (914) 821-8217

Email: gwen.nichols@lls.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: In Arm A (control arm), participants will receive azacitidine in monotherapy.

More studies in Acute Myeloid Leukemia

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• ONC-LEUK-2406: The Impact of Systematic Financial Navigation in Acute Myeloid Leukemia — Charlotte, North Carolina
• Gamma Delta T-cell Infusion for AML at High Risk of Relapse After Allo HCT — Tampa, Florida
• Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy — Little Rock, Arkansas
• A Study of the Combination of Ivosidenib, Azacitidine, and Venetoclax Followed by Ivosidenib Alone in People With Acute Myeloid Leukemia — Basking Ridge, New Jersey
• A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine, Venetoclax, 7+3, or 7+3+Quizartinib in Patients With AML — Phoenix, Arizona

Explore by condition: All Acute Myeloid Leukemia clinical trials

💡 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.