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Spots Global Cancer Trial Database for Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Roberto Foà, Prof.

Affiliation: Dipartimento di Biotecnologie Cellulari ed Ematologia "Sapienza" Università degli Studi di Roma

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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