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
Phase
Current status
It is unknown whether this trial is still recruiting participants.
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
Other trial ID
ClinicalTrials.gov NCT03895671
What is the purpose of the study
The aim of the trial is to evaluate the azacitidine in combination with ponatinib and to improve the survival of patients with CML in advanced phase and myeloid blast crisis.
What will happen during 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. This treatment schedule will also reduce toxicity as compared to intensive chemotherapy + tyrosine kinase inhibitors.
Key inclusion criteria
This study includes patients of all sexes who:
- are aged 18 years or older
- 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, 1, 2, or 3
- have adequate kidney and liver function and normal pancreas status
Further criteria may apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- are pregnant or lactating women,
- have participated in another clinical trial with any investigative drug within 30 days prior to study enrolment,
- have undergone hematopoietic stem cell transplantation
Further criteria may apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US register ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
You can also find a 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