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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

Ponatinib

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

Useful links and downloads for this trial

Clinicaltrials.gov

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