drugset / Trial / NCT04475731

Ponatinib in Adult Ph+ ALL Patients With MRD Positivity or Hematological Relapse

NCT04475731

Phase 2 Active not recruiting 67 enrolled GIMEMA Foundation
NaSingle-groupOpen-labelTreatment

Summary

This is a phase II interventional trial to evaluate if the use of ponatinib, with or without chemotherapy, can induce a molecular remission in MRD-positive patients, in patients in hematologic and extra-hematologic relapse and in the few patients who never achieved an hematologic remission after whatever prior treatment.

Timeline

Start
2021-05-04
Primary completion
2024-11
Completion
2024-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Ponatinib Small molecule 45 mg Oral
Background Cytarabine Small molecule
Background Leucovorin Small molecule
Background Methotrexate Small molecule
Background Prednisone Other / unclassified
Background Vincristine Small molecule