OncoMatch/Clinical Trials/NCT05101551
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
Is NCT05101551 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Talazoparib and Topotecan for acute myeloid leukemia.
Treatment: Talazoparib · Topotecan · Gemcitabine — This is a Phase 1, open label, multicenter, dose finding study with dose expansion intended to evaluate the safety and tolerability of talazoparib in combination with conventional chemotherapy. Preliminary estimates of efficacy will be obtain through a dose expansion cohort receiving the maximum tolerated dose from the dose escalation phase of the study. This study aims to determine the safety of talazoparib in combination with conventional chemotherapy and to establish the maximum tolerated dose of all 3 drugs when given in combination. A preliminary estimate of efficacy through a dose expansion phase is a secondary aim.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Prior therapy
Must have received: induction chemotherapy
refractory (persistent leukemia after at least 2 courses of induction chemotherapy) or relapsed
Lab requirements
Blood counts
WBC ≤ 50,000/uL (may be achieved using cytoreductive therapy such as hydroxyurea or low-dose cytarabine)
Kidney function
Estimated serum creatinine ≥ 60 mL/min/1.73m2
Liver function
Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age; AST/ALT ≤ 5 x ULN for age
Cardiac function
Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%
WBC ≤ 50,000/uL. Total bilirubin ≤ 2.0 x institutional upper limit of normal (ULN) for age. AST/ALT ≤ 5 x ULN for age. Left ventricular ejection fraction ≥ 40% or ECHO shortening fraction ≥ 25%. Estimated serum creatinine ≥ 60 mL/min/1.73m2
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial 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
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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