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 description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Scientific abstract on the combination of a TKI and azacytidine in CML patients in advanced phases
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