coiaward2010

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 (ClinicalTrials.gov NCT02398825)

Indication and most important 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).

Short description of intervention

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.

Type of study

Trial after therapy failure or intolerance

Current status

Recruiting

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

Additional information

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

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

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

San Giovanni Rotondo
N. Cascavilla

Siena
M. Bocchia

Terni
A. M. Liberati

Treviso
F. Gherlinzoni

Verona
M. Bonifacio

Vicenza
E. Di Bona