TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II
The study will test the ability of a type of immunotherapy called blinatumomab to clear persistent leukemia. Blinatumomab targets CD19 which is located on the leukemia cells outer membrane.
Sponsor: Tanja A. Gruber, MD
Protocol: POE23-01
Principal investigator: Tanja A. Gruber, MD
Site: 27 sites across North America
Estimated accrual years: 5.0
PARPAML: A Phase 1 Protocol for Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination with Chemotherapy
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.
Sponsor: Dr. Kamens
Protocol: POE22-01
Principal investigator: Jennifer Kamens, MD
Site: Stanford University
Estimated accrual years: 2.0
Safety and dose finding study of Neratinib in children and young adults with cancer that has returned or not responded to treatment
A Phase I/II study of Neratinib in pediatric patients with relapsed or refractory solid tumors or hematologic malignancies
Sponsor: Puma
Protocol: POE16-01
Principal investigator: Tanya Trippett, MD
Site: Memorial Sloan Kettering Cancer Center
Estimated accrual years: 1.0 (Phase I); 1.5 (Phase II)