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

Type of study

Treatment of advanced phases

Phase

2

Current status

It is unknown whether this trial is still recruiting participants.

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:

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

December 2023

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