Spots Global Cancer Trial Database for Nilotinib in PH+, BCR-, ABL+ CML Patients
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Trial Identification
Brief Title: Nilotinib in PH+, BCR-, ABL+ CML Patients
Official Title: The Protein Tyrosine Kinase Inhibitor Nilotinib as First-line Treatment of Ph+, BCR-, ABL+ Chronic Myeloid Leukemia (CML) in Early Chronic Phase: a Phase IIIb, Multicenter Study to Assess the Complete Molecular Response
Study ID: NCT01535391
Conditions
Interventions
Study Description
Brief Summary: This study is an open-label, multicentric, phase IIIb study of NILOTINIB administered orally twice daily for 24 months and indefinitely if it is in the interest of the patient. The primary objective of the trial is to evaluate the efficacy of nilotinib, 300 mg twice daily with dose increase to 400 mg twice daily in case of suboptimal response or failure (excluding patients who will fail for progression to ABP), in a population of patients with Ph-positive, BCR-ABL positive CML in early CP.
Detailed Description: This study is an open-label, multicentric, phase IIIb study of NILOTINIB administered orally at the dose of 300 mg twice daily (total daily dose 600 mg daily) for 24 months (study core), and indefinitely if it is in the interest of the patient (the drug will be given free-of-charge after 24 months to all those patients achieving the CMR4 at 24 months and in absence of safety concerns). Nilotinib dose is increased to 400 mg BID in case of suboptimal response or failure (with the exception of patients who will fail for progression to ABP: in case of progression to ABP, the patient will not be treated with study drug and the choice of the treatment will be up to the physician). Study duration is estimated in 6 years, 1 year of estimated enrollment, 2 years therapy duration. Thereafter, information on course and survival is due for other 3 years. The main data analysis will be performed when all patients will complete 24 months of treatment (or discontinued earlier). Safety and tolerability profile will be assessed by collecting hematologic and non-hematologic adverse events, laboratory examinations and ECG data. The molecular response will be assessed using the GIMEMA standardized molecular laboratories (Labnet network).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Azienda Ospedaliera Nuovo Ospedale "Torrette", Ancona, , Italy
S.G. Moscati Hospital, Avellino, , Italy
Azienda Ospedaliera Di Bologna Policlinico S. Orsola - Malpighi, Bologna, , Italy
USD Trapianti di midollo per adulti - Cattedra di Ematologia - Università degli Studi di Brescia, Brescia, , Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto", Catania, , Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia, Catanzaro, , Italy
Sezione di Ematologia e Fisiopatologia delle Emostasi - Azienda Ospedaliera - Arcispedale S. Anna, Ferrara, , Italy
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria, Foggia, , Italy
Clinica Ematologica - DiMI - Università degli Studi di Genova, Genova, , Italy
Divisione Ematologia 1 - Azienda Ospedaliera Universitaria "San Martino", Genova, , Italy
U.O. di Ematologia- Ospedale dell'Angelo - Mestre, Mestre, , Italy
U.O. Ematologia e Trapianto di MIdollo - Ist.Scientifico Ospedale San Raffaele, Milano, , Italy
Centro Oncologico Modenese - Dipartimento di Oncoematologia, Modena, , Italy
Università degli Studi di Padova - Ematologia ed Immunologia Clinica, Padova, , Italy
Ospedale Cervello, Palermo, , Italy
Azienda Ospedaliera Universitaria - Policlinico Paolo Giaccone, Palermo, , Italy
Div. di Ematologia di Muraglia -CTMO Ospedale San Salvatore, Pesaro, , Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza, Piacenza, , Italy
Dipartimento Oncologico - Ospedale S.Maria delle Croci, Ravenna, , Italy
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli", Reggio Calabria, , Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova, Reggio Emilia, , Italy
Ospedale "Infermi", Rimini, , Italy
IRCCS Centro di riferimento Oncologico di Basilicata, Rionero in Vulture, , Italy
Complesso Ospedaliero S. Giovanni Addolorata, Roma, , Italy
Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza", Roma, , Italy
U.O.C. Ematologia Ospedale S. Eugenio, Roma, , Italy
Università degli Studi Policlinico di Tor Vergata, Roma, , Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte", Siena, , Italy
U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati, Taranto, , Italy
SCDO Ematologia 2 AOU S.Giovanni Battista, Torino, , Italy
Azienda USL 9 Treviso - U.O. di Ematologia, Treviso, , Italy
Clinica Ematologica - Policlinico Universitario, Udine, , Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi, Verona, , Italy
Contact Details
Name: Gianantonio Rosti
Affiliation: Dpt of Hematology and Oncology, "Seràgnoli", Sant'Orsola-Malpighi. University Hospital of Bologna
Role: STUDY_CHAIR
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