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Brief Title: Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Official Title: Ancillary Observational Study of Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients With Dasatinib and the Bispecific Monoclonal Antibody Blinatumomab
Study ID: NCT03318770
Brief Summary: The primary objective of the present study is to evaluate the long-term observation, in terms of overall survival, of adult Ph+ ALL patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to GIMEMA protocol LAL2116.
Detailed Description: Since the treatment after dasatinib and blinatumomab is not uniform and highly dependent on medical decisions, the primary aim of this ancillary trial is to evaluate the long-term follow-up of patients enrolled in the GIMEMA 2116, in terms of overall survival (OS). Furthermore, the secondary objectives are the collection of data and survival outcomes relative to the therapeutic choices carried out after dasatinib and blinatumomab (i.e. allo-SCT, autologous transplant, TKI maintenance, etc), duration of CMR, DFS, long-term safety profile. A correlation of survival outcomes (OS, DFS, etc) with the clinical and biological findings will be carried out with data collected at diagnosis and during the follow-up within the LAL2116 trial.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto, Bari, , Italy
Asst Papa Giovanni Xxiii - Ospedale Di Bergamo - Sc Ematologia, Bergamo, , Italy
Asst Degli Spedali Civili Di Brescia - Uo Ematologia, Brescia, , Italy
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania, Catania, , Italy
Aou Careggi - Firenze - Sod Ematologia, Firenze, , Italy
Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia, Lecce, , Italy
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia, Mestre, , Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora, Milano, , Italy
Aou Maggiore Della Carita' Di Novara - Scdu Ematologia, Novara, , Italy
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia, Orbassano, , Italy
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia, Pagàni, , Italy
Aou Di Parma - Sc Ematologia E Centro Trapianti Midollo Osseo, Parma, , Italy
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo, Perugia, , Italy
Aou Policlinico Tor Vergata - Roma - Uoc Trapianto Cellule Staminali, Roma, , Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia, Roma, , Italy
Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma, Rome, , Italy
Aou Integrata Di Verona, Policlinico G.B. Rossi - Uoc Ematologia, Verona, , Italy
Name: Roberto Foà, Prof.
Affiliation: Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma
Role: STUDY_CHAIR