Relapsed Pediatric AML to Determine the Safety and Efficacy of the PARP Inhibitor Talazoparib in Combination With Conventional Chemotherapy

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Gemcitabine; Talazoparib; Topotecan

Criteria

Inclusion Criteria:

• 1. AML or acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia) and have (a) refractory leukemia, defined as persistent leukemia after at least two courses of induction chemotherapy, OR (b)relapsed leukemia, defined as ≥ 1% blasts in the bone marrow OR rising MRD by flow cytometry on two or more serial samples.

If an adequate bone marrow sample cannot be obtained, subjects may be enrolled if there is unequivocal evidence of leukemia with ≥ 5% blasts in the peripheral blood.

Exclusion Criteria:

• 1. Uncontrolled infection. Infections controlled on concurrent anti microbial agents are acceptable, and anti microbial prophylaxis per institutional guidelines are acceptable.