Spots Global Cancer Trial Database for Activity and Risk Profile of Ponatinib in Chronic Phase Patients With Chronic Myeloid Leukemia Resistant to Imatinib
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Trial Identification
Brief Title: Activity and Risk Profile of Ponatinib in Chronic Phase Patients With Chronic Myeloid Leukemia Resistant to Imatinib
Official Title: Optimizing Ponatinib USe (OPUS). 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
Study ID: NCT02398825
Interventions
Study Description
Brief Summary: This study aims at evaluating the efficacy of treatment with ponatinib in patients with chronic myeloid leukemia who are in a chronic phase and who previously received treatment with imatinib but resulted to be resistant to it.
Detailed Description: Phase 2, single-arm, multicentre, open label. No interim analysis is planned, but a monitoring committee will evaluate the data every 6 months. Ponatinib is given orally 30 mg daily, with dose adjustment to 15 mg daily once a BCR-ABL1 level smaller or equal to 0.1% (MMR) has been achieved and confirmed in the next test, 4 weeks apart. A return to prior, 30 mg, dose is due in case of return of BCR-ABL1 transcripts level to \> 1%. Dose adjustments for toxicity are detailed in the protocol. Treatment time will be 52 weeks, during which study drug will be provided free-of-charge by ARIAD Pharmaceuticals, upon approval of the protocol. Treatment is discontinued at any time in case of failure or treatment-related SAEs. After one year of treatment, upon request of the local investigator and upon confirmation of the Treatment Advisory Committee (TAC, see section 23), ARIAD Pharmaceutics, Inc. will continue to provide ponatinib for the study patients who will benefit from treatment continuation, for at least 2 years, until the drug will be approved with that indication.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Aos Ss. Antonio E Biagio E C. Arrigo - Soc Ematologia, Alessandria, , Italy
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi, Ancona, , Italy
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi, Bologna, , Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia, Brescia, , Italy
Ao Brotzu, Presidio Ospedaliero A. Businco - Sc Ematologia E Ctmo, Cagliari, , Italy
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo, Catania, , Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto", Catania, , Italy
Ao Di Catanzaro "Pugliese-Ciaccio", Presidio Ospedaliero "Ciaccio - de Lellis" - Ematologia, Catanzaro, , Italy
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione, Cona, , Italy
Aso S. Croce E Carle - Cuneo - Sc Ematologia, Cuneo, , Italy
Irccs Aou San Martino - Genova - Uo Clinica Ematologica, Genova, , Italy
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia, Lecce, , Italy
.R.S.T. Srl Irccs - Meldola - Sc Oncologia Medica, Meldola, , Italy
Aou Policlinico "G. Martino" - Messina - Uoc Ematologia, Messina, , Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano, Milano, , Italy
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia, Milano, , Italy
Milano Unità Trapianto di Midollo Ist. Nazionale Tumori, Milano, , Italy
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo, Napoli, , Italy
Aou Federico Ii - Napoli - Uoc Ematologia, Napoli, , Italy
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia, Orbassano, , Italy
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo, Palermo, , Italy
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia, Palermo, , Italy
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia, Pavia, , Italy
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica, Pescara, , Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto, Piacenza, , Italy
Aou Pisana - Uo Ematologia Universitaria, Pisa, , Italy
Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia, Ravenna, , Italy
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia, Rimini, , Italy
Ao San Camillo Forlanini - Roma - Uoc Ematologia E Trapianto Cellule Staminali, Roma, , Italy
Asl Roma 2, Ospedale S. Eugenio- Ospedale S.Eugenio - Uoc Ematologia, Roma, , Italy
Roma Uoc Pronto Soccorso E Accettazione Ematologica - Dipartimento Biotecnologie Cellulari Ed Ematologia - Università Degli Studi Di Roma "Sapienza", Roma, , Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia, San Giovanni Rotondo, , Italy
Aou Senese - Uoc Ematologia E Trapianti, Siena, , Italy
Ao S. Maria - Terni - Sc Onco Ematologia, Terni, , Italy
Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana, Treviso, , Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia, Verona, , Italy
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia, Vicenza, , Italy
Contact Details
Name: Fausto Castagnetti
Affiliation: Department of Hematology, S. Orsola-Malpighi University of Bologna
Role: STUDY_CHAIR
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