Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy (NCT05101551)

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. Aged ≤ 21 years.
2. Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia), specified as either refractory (persistent leukemia after at least 2 courses of induction chemotherapy) or relapsed, and further defined as any one of the criteria below:
3. Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics Inc.
4. A single bone marrow specimen with at least 2 tests demonstrates ≥ 1% leukemic blasts by flow cytometry (as assessed by Hematologics Inc), AND at least one of the following:
5. Karyotypic abnormality with at least 1 metaphase similar or identical to diagnosis
6. FISH abnormality identical to one present at diagnosis
7. PCR or NGS-based demonstration of leukemogenic lesion identical to diagnosis
8. Rising MRD \> 0.1% by flow cytometry on ≥ 2 serial samples, as assessed by Hematologics Inc.
9. If an adequate bone marrow sample is not obtained, subjects may be enrolled if there is unequivocal evidence of leukemia based on ≥ 5% blasts in the peripheral blood
10. \> 60 days has passed since hematopoietic stem cell transplant.
11. Patients who have undergone previous allogeneic stem cell transplantation who are otherwise eligible must also be without evidence of any active graft versus host disease (GVHD), and off calcineurin inhibitors for at least 28 days (four weeks) prior to therapy. A physiologic dose of prednisone up to 3 mg/m2 (and a maximum of 7.5 mg) or equivalent other steroid dose is allowable.
12. A minimum of 14 days has passed since completion of myelosuppressive therapy or gemtuzumab ozogamicin and all nonhematologic toxicities have resolved to Grade 0 or 1.

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

📍 All Participating Trial Locations (9 Sites)

• Phoenix Children's Hospital — Phoenix, Arizona
• Arkansas Children's Hospital — Little Rock, Arkansas
• City of Hope — Duarte, California
• Stanford University — Stanford, California
• Cincinnati Children's Hospital — Cincinnati, Ohio
• Pennsylvania State University Hershey Medical Center — Hershey, Pennsylvania
• St. Jude Children's Research Hospital — Memphis, Tennessee
• University of Utah — Salt Lake City, Utah
• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin

💰 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.