drugset / Trial / NCT05306301

Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients

NCT05306301

Phase 2 Active not recruiting 32 enrolled GIMEMA Foundation
NaSingle-groupOpen-labelTreatment

Summary

Acute lymphoblastic leukemia (ALL) is the most frequent cancer in children, decreases in adolescence and adulthood, and a second peak can be recorded starting from the 6th decade of life. While the outcome in children is excellent, in the adolescent/adult population, the prognosis, though improved over the decades, it is still unsatisfactory and novel biologically-driven approaches are urgently needed. In this setting, thanks to the introduction of genome wide technologies, it was possible to recognize specific subset of ALL. Among those, the BCR/ABL1-like ALL are of extreme importance, since they are characterized by an unfavourable outcome and, on the other hand, can benefit of a targeted treatment, in particular with the pan-tyrosine kinase inhibitor ponatinib. The primary objective is to evaluate the clinical response - in terms of MRD negativity - in patients with a BCR/ABL1-like profile, according to the BCR/ABL1-like predictor tool, treated with Ponatinib in combination with chemotherapy.

Timeline

Start
2022-10-05
Primary completion
2026-03-01
Completion
2028-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ponatinib Small molecule 15 mg Oral
Subject Ponatinib Small molecule 30 mg Oral