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

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)

Indication and most important 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.

Short description of intervention

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.

Type of study

Treatment of advanced phases

Current status

Recruitment on hold

Study sponsor

Hôpitaux de Versailles, France

Scientific lead / contact

Philippe Rousselot, Hôpitaux de Versailles

Principal investigator

Philippe Rousselot, Hôpitaux de Versailles

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 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