Actively Recruiting
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
Led by Norman J. Lacayo · Updated on 2026-04-22
34
Participants Needed
9
Research Sites
214 weeks
Total Duration
On this page
Sponsors
N
Norman J. Lacayo
Lead Sponsor
G
Gateway for Cancer Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Talazoparib in Combination With Chemotherapy in Relapsed Pediatric AML to Determine Safety and Efficacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or younger
- Diagnosis of acute myeloid leukemia (AML) or acute leukemia of ambiguous lineage that is refractory or relapsed
- Bone marrow with at least 5% leukemic blasts by flow cytometry or evidence of leukemia by specific tests or peripheral blood
- More than 60 days since hematopoietic stem cell transplant
- No active graft versus host disease and off calcineurin inhibitors for at least 28 days if previously transplanted
- At least 14 days since last myelosuppressive therapy or gemtuzumab ozogamicin, with resolved toxicities
- At least 24 hours since low-dose or non-myelosuppressive therapy
- Lansky or Karnofsky performance score of 50 or higher
- White blood cell count 50,000/uL or less, possibly controlled with cytoreductive therapy
- Total bilirubin less than or equal to 2 times institutional upper limit of normal for age
- AST and ALT less than or equal to 5 times upper limit of normal for age
- Left ventricular ejection fraction 40% or higher or ECHO shortening fraction 25% or higher
- Estimated serum creatinine clearance 60 mL/min/1.73m2 or higher
You will not qualify if you...
- Receiving or planning to receive any other cancer therapy including chemotherapy, radiation, immunotherapy, or biologic therapy
- Diagnosis of Down syndrome
- Diagnosis of Acute Promyelocytic Leukemia (APL) or Juvenile Myelomonocytic Leukemia (JMML)
- Diagnosis of Bone Marrow Failure Syndrome
- Pregnancy or unwillingness to use effective birth control
- Female subjects with infants who do not agree to abstain from breastfeeding
- Inability or unwillingness of legal guardian or representative to provide written informed consent
- Uncontrolled systemic fungal, bacterial, viral, or other infections
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
2
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
4
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
5
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
6
Pennsylvania State University Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Actively Recruiting
7
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
8
University of Utah
Salt Lake City, Utah, United States, 84108
Actively Recruiting
9
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
S
Stefania Chirita
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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