OPUS = Optimizing Ponatinib Use [Italy]
Study title
Optimizing Ponatinib Use (OPUS)
Scientific title
A GIMEMA Phase 2 Study of the Activity and Risk Profile of Ponatinib, 30 mg Once Daily, in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) Patients Resistant to Imatinib (EudraCT no. 2015-001102-34, ClinicalTrials.gov NCT02398825)
Type of study
Trial after therapy failure or intolerance
Current status
No longer recruiting
What is the purpose of the study
The purpose of this study is to evaluate ponatinib in patients with chronic myeloid leukemia in chronic phase who were previously treated with imatinib but shown resistance to it.
Patients will be given ponatinib 30 mg daily by mouth. Once a BCR-ABL1 level smaller or equal to 0.1% (MMR) has been achieved and confirmed by a second test after 4 weeks, the dose will be reduced to 15 mg daily. If BCR-ABL1 levels return to above 1%, the ponatinib dose will be increased again to 30 mg. The dose will be adjusted if adverse events occur. Each patient will be treated in the study for 52 weeks.
Key inclusion criteria
Male or female patients 18 years of age or older with a cytogenetic or molecular confirmed diagnosis of BCR-ABL1+ CML in chronic phase.
Patients can be considered for inclusion in the study if they have been treated with imatinib at any dose but not responded to treatment (as assessed according to any one of the ELN 2013 criteria).
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
Study sponsor
Gruppo Italiano Malattie EMatologiche dell’Adulto
Scientific lead / contact
Prof. Gianantonio Rosti
Department of Oncology and Hematology
O.U. of Hematology
S. Orsola-Malpighi University Hospital
Bologna, Italy
Principal investigator
Prof. Gianantonio Rosti
Department of Oncology and Hematology
O.U. of Hematology
S. Orsola-Malpighi University Hospital
Bologna, Italy
Study centers / principal investigators
Italy
Alessandria
V. Giai
Bologna
S. Orsola-Malpighi University Hospital
G. Rosti
Brescia
Spedali Civili – Azienda Ospedaliera
G. Rossi
Cagliari
Businco
E. Usala
Catania
Ospedale “Ferrarotto”
F. Di Raimondo
Catanzaro
Molica
Cuneo
D. Rapezzi
Ferrara
A. Cuneo
Genova
IRCCS
Prof. M.Gobbi
Lecce
N. Di Renzo
Meldola
A. Lucchesi
Messina
Policlinico G. Martino
C. Musolino
Milano
IRCCS Ospedale
A. Iurlo
Milano
Ist. Nazionale Tumori
F. Spina
Milano
San Raffaele
F. Ciceri
Napoli
Cardarelli
M. Annunziata
Napoli
Univ. Studi Napoli – Federico II
F. Pane
Orbassano
C. Rege Cambrin
Palermo
Ospedali Riuniti “Villa Sofia-Cervello”
F. Fabbiano
Palermo
Policlinico “Paolo Giaccone”
V. Accurso
Pavia
E. M. Orlandi
Pescara
P. Di Bartolomeo
Piacenza
Ospedale G. da Saliceto
D. Vallisa
Pisa
S. Galimberti
Ravenna
M. Salvucci
Rimini
A. L. Molinari
Roma
Ospedale Sant’Eugenio
E. Abruzzese
Roma
S.Camillo Forlanini Hospital
Dr. S.Mancini
San Giovanni Rotondo
N. Cascavilla
Siena
M. Bocchia
Terni
A. M. Liberati
Treviso
F. Gherlinzoni
Verona
M. Bonifacio
Vicenza
E. Di Bona