PONAZA – Ponatinib and subcutaneous azacitidine in chronic myelogenous leukemia patients in accelerated phase or in myeloid blast crisis [France]

Type of study

Treatment of advanced phases

Current status

Recruiting

Study title

PONAZA – A combination of ponatinib and subcutaneous azacitidine in chronic myelogenous leukemia patients in accelerated phase or in myeloid blast crisis

Scientific title

Open Label Phase 2 Study on the efficacy and tolerance of a combination of ponatinib and 5-azacitidine in chronic myelogenous leukemia in accelerated phase or in myeloid blast crisis (ClinicalTrials.gov NCT03895671)

What is the purpose of the study

In this study, azacitidine will be given in addition to the tyrosine kinase inhibitor ponatinib to treat patients with either CML in advanced phase or myeloid blast crisis. The aim of the trial is to evaluate the activity of azacitidine in combination with ponatinib and to improve the survival of patients with CML in advanced phase and myeloid blast crisis. This treatment schedule will also reduce toxicity as compared to intensive chemotherapy + tyrosine kinase inhibitors.

What will happen during the study

Key inclusion criteria

This study includes patients who:
– are at least 18 years old
– have Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in blast crisis (CML-BP) or accelerated phase (CML-AP)
– have an Eastern Co-Operative Group (ECOG) status of 0-3
– have adequate kidney and liver function and normal pancreas status

Other criteria may apply.

Key exclusion criteria

Where can I find additional information

Study sponsor

Hôpitaux de Versailles, France

Scientific lead / contact

Philippe Rousselot, Hôpitaux de Versailles

Principal investigator

Philippe Rousselot, Hôpitaux de Versailles

Study centers / principal investigators

France

Amiens
Centre Hospitalier Universitaire D’Amiens
Delphine Lebon

Chambéry
Centre Hospitalier Metropole Savoie
Gian Matteo Pica

Grenoble
Centre Hospitalier Universitaire de Grenoble
Stéphane Courby

Paris
Hôpital St Louis
Emmanuel Raffoux

Versailles
Centre Hospitalier de Versailles
Philippe Rousselot