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

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 expan

Trial Details

NCT ID
NCT05101551
Phase
PHASE1
Sponsor
Norman J. Lacayo
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Talazoparib
  • Topotecan
  • Gemcitabine
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Duarte, California, United States|34.13945,-117.97729
  • Stanford, California, United States|37.42411,-122.16608
  • Cincinnati, Ohio, United States|39.12711,-84.51439

Key Eligibility Criteria

  • Aged ≤ 21 years.
  • Acute myeloid leukemia (AML) OR acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia), specified …
  • Bone marrow specimen ≥ 5% leukemic blasts by flow, as assessed by Hematologics Inc.
  • A single bone marrow specimen with at least 2 tests demonstrates ≥ 1% leukemic blasts by flow cytometry (as assessed by Hematologics Inc), AND at l…

For full eligibility, visit ClinicalTrials.gov.

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