CarPAs = Cardiovascular assessment of ponatinib as third line treatment in CML [Italy]

What is the purpose of the study

The purpose of this study is to evaluate the therapeutic activity and cardiovascular safety of ponatinib in patients with chronic myeloid leukemia in chronic phase who were previously treated with imatinib and then switched to bosutinib (or vice versa) but shown resistance or intolerance to the treatment.

Patients with resistance to previous treatment will be given ponatinib 15 mg once daily as tablets by mouth.

Patients with intolerance to previous treatment will be given ponatinib 30 mg once daily as tablets by mouth. The dose will be reduced to 15 mg once daily as soon as complete cytogenetic response has been achieved. In patients who achieve major molecular response (MMR) or better, the dose can be further reduced to 15 mg every other day.

Key inclusion criteria

Male or female patients 18 years of age or older with a diagnosis of Chronic Myeloid Leukemia (CML) in chronic phase (CP).

Patients can be considered for inclusion in the study if they have been treated with imatinib and bosutinib or bosutinib only and are resistant or intolerant to imatinib and/or bosutinib. Previous treatment with dasatinib or nilotinib will not be allowed.

To be considered for inclusion, patients must have a life expectancy of at least 3 months, adequate organ function, and an Eastern Co-Operative Oncology Group (ECOG) status of 0, 1 or 2.

Key exclusion criteria

Estimated primary completion date

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study centers / principal investigators

Italy

Presidio Ospedaliero “Oncologico Businco”
Cagliari, 09121
Principal Investigator: Giovanni Caocci

AOU “Policlinico Vittorio Emanuele”
Catania, 95121
Principal Investigator: Fabio Stagno

Ospedale San Gerardo
Monza (MB)
Milano, 20090
Principal Investigator: Carlo Gambacorti Passerini

Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico
Milano, 20122
Principal Investigator: Alessandra Iurlo

Azienda Ospedaliera Universitaria “Federico II”
Napoli, 80131
Principal Investigator: Luigia Luciano

Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
Principal Investigator: Chiara Elena

Grande Ospedale Metropolitano “Bianchi-Melacrino-Morelli”
Reggio Calabria, 89133
Principal Investigator: Bruno Martino

AUSL Reggio Emilia
Reggio Emilia, 42122
Principal Investigator: Isabella Capodanno

ASL Roma 2 “Ospedale S. Eugenio”
Roma, 00144
Principal Investigator: Elisabetta Abruzzese

AOU Policlinico Umberto I “Università La Sapienza”
Roma, 00161
Principal Investigator: Roberto Latagliata

Azienda Ospedaliero-Universitaria Senese
Siena, 53100
Principal Investigator: Monica Bocchia

AOU Città della Salute e della Scienza
Torino, 10126
Principal Investigator: Patrizia Pregno

AOU Integrata Verona “Ospedale Borgo Roma”
Verona, 37134
Principal Investigator: Massimiliano Bonifacio