drugset / Trial / NCT03895671

PONAZA : A COMBINATION OF PONATINIB AND 5-AZACITIDINE IN CHRONIC MYELOGENOUS LEUKAEMIA IN ACCELERATED PHASE OR IN MYELOID BLAST CRISIS

NCT03895671

Phase 2 Completed 32 enrolled Versailles Hospital
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This project is strategy aiming to improve the survival of patients with chronic myelogenous leukemia in advanced phase and myeloid blast crisis. The basis of this strategy is to add the demethylating agent 5-Azacitidine to the tyrosine kinase inhibitor ponatinib and evaluate its activity in 2 cohorts of patients with either chronic myelogenous leukemia in advanced phase or myeloid blast crisis.

Timeline

Start
2019-06-19
Primary completion
2025-08-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified 75 mg/m2 Subcutaneous
Subject Ponatinib Small molecule 15 mg Oral
Subject Ponatinib Small molecule 30 mg Oral
Subject Ponatinib Small molecule 45 mg Oral