Back to search results

Study of Talazoparib with Chemotherapy for Relapsed Pediatric AML

This study is for children and young adults up to 21 years old with acute myeloid leukemia (AML) that has come back or hasn't responded to previous treatments. It's testing a new combination of medicines: Talazoparib, Topotecan, and Gemcitabine. The main goal is to find the safest and most effective dose of these three drugs when given together. Researchers will also look at how well this combination works to treat AML. This study is currently unclear regarding its recruitment status and plans to enroll 34 participants.

Study design
This is a Phase 1, open-label study, meaning both you and your doctors will know which treatments you are receiving. It aims to find the right dose of the study drugs and will involve about 34 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoint, dose limiting toxicity, is measured 28 days after starting therapy.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05101551

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

Recruiting
PHASE1Up to 21InterventionalTreatment
Norman J. Lacayo
~34 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:TalazoparibTopotecanGemcitabine

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose limiting toxicity (DLT).
Measured over 28 days after starting therapy (ie, single course of therapy).

Conditions

Acute Myeloid Leukemia

Explore related trials

Acute Myeloid LeukemiaAcute Undifferentiated LeukemiaMixed Phenotype Acute Leukemia

Where it's being run

9 sites across 8 states
California2
Arizona1
Arkansas1
Ohio1
Pennsylvania1
Tennessee1
Utah1
Wisconsin1

Study leadership

  • Norman Lacayo, MD · PRINCIPAL_INVESTIGATOR · Stanford Universiy

Who to contact

Stefania Chirita
[email protected]
(650)721-4087
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Karyotypic abnormality with at least 1 metaphase similar or identical to diagnosis
FISH abnormality identical to one present at diagnosis
PCR or NGS-based demonstration of leukemogenic lesion identical to diagnosis 3. Rising MRD \> 0.1% by flow cytometry on ≥ 2 serial samples, as assessed by Hematologics Inc. 4. 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 3. \> 60 days has passed since hematopoietic stem cell transplant. 4. 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. 5. 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. 6. A minimum of 24 hours has elapsed since the patient has completed any low-dose or non-myelosuppressive therapy (e.g., hydroxyurea or low-dose cytarabine (up to 100 mg/m2). 7. Lansky (subjects ≤ 16 years old) or Karnofsky (subjects \> 16 years old) score ≥ 50. 8. WBC ≤ 50,000/uL. This may be achieved using cytoreductive therapy such as hydroxyurea or low-dose cytarabine (up to 100 mg/m2/dose) 9. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age. 10. AST/ALT ≤ 5 x ULN for age 11. Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%. 12. Estimated serum creatinine ≥ 60 mL/min/1.73m2

What this trial measures

  • Dose limiting toxicity (DLT).28 days after starting therapy (ie, single course of therapy).

    Patient safety is assessed as dose limiting toxicity (DLT). The outcome is the number of DLT events. A DLT event is defined as: * Hematologic DLT - Failure to recover peripheral ANC to \> 200/µL or non-transfusion-dependent platelets to \> 20,000/µL by Day 43 from the start of Cycle 1 of chemotherapy will be considered a DLT, unless the delay in count recovery is due to another identifiable factor * Non-Hematologic DLT-Any ≥ Grade 4 non-hematological organ toxicity, including Hy's Law case is a DLT with the following exceptions: * Grade 4 infection or fever ≤ 7 days in duration. * Grade 4 electrolyte or laboratory abnormalities correctable with supportive therapy or that resolve to \< Grade 3 within 72 hours. * Grade 4 elevation in hepatic transaminases that resolves to ≤ Grade 2 within 7 days. * Grade 4 tumor lysis syndrome must resolve in ≤ 7 days without evidence of end-organ damage.