Spots Global Cancer Trial Database for Phase II Study About Combination CHOP-21, Obinutuzumab and Ibrutinib in Untreated Young High Risk DLBCL Patients.
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Trial Identification
Brief Title: Phase II Study About Combination CHOP-21, Obinutuzumab and Ibrutinib in Untreated Young High Risk DLBCL Patients.
Official Title: Multicenter Phase II Single Arm Open-label Study on the Feasibility, Safety and Efficacy of Combination of CHOP-21 Supplemented With Obinutuzumab and Ibrutinib in Untreated Young High Risk Diffuse Large B-cell Lymphoma (DLBCL) Patients.
Study ID: NCT02670317
Conditions
Study Description
Brief Summary: This is a prospective, multicenter, single arm, phase II trial in young patients (18-60 years) with poor-prognosis (aaIPI 2 or 3) newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL). Aim of the study is to assess the efficacy and the safety of G-CHOP in combination with ibrutinib.
Detailed Description: This is a prospective, multicenter, single arm, phase II trial in young patients (18-60 years) with poor-prognosis (age-adjusted International Prognostic Index, aaIPI, 2 or 3) newly diagnosed Diffuse Large B-cell Lymphoma (DLBCL). Patient will receive 6 courses of G-CHOP21 (Obimutizumab- cyclophosphamide, hydroxydaunomycin, Oncovin, and prednisone) followed by 2 doses of Obinutuzumab supplemented with Ibrutinib. Duration of treatment will be 5 months plus 4-5 weeks for response evaluation. During the study, disease status will be evaluated after the 4th cycle by computed tomography (CT) scan, and after end of treatment by imaging test (18FDG-PET \[positron emission tomography\] and CT scan). Patients will be recruited over 2 years and followed for a minimum of 2 years after the end of the treatment phase.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
Locations
IRCCS Candiolo - Fondazione del Piemonte per l'oncologia, Candiolo, TO, Italy
AO SS. Antonio e Biagio e C. Arrigo, Alessandria, , Italy
AOU Policlinico Consorziale, Bari, , Italy
AO Papa Giovanni XXIII, Bergamo, , Italy
Ospedale di Bolzano, Bolzano, , Italy
Ospedale Businco, Cagliari, , Italy
AO di Cosenza, Cosenza, , Italy
AOU Careggi, Firenze, , Italy
P.O. Vito Fazzi, Lecce, , Italy
IRST Meldola, Meldola, , Italy
Ospedale Papardo, Messina, , Italy
Istituto Europeo Oncologico, Milano, , Italy
AOU Policlinico di Modena, Modena, , Italy
Ospedale San Gerardo, Monza, , Italy
IRCCS Napoli Pascale, Napoli, , Italy
Ospedale Maggiore della Carità, Novara, , Italy
AOOR Villa Sofia Cervello, Palermo, , Italy
AOU di Parma, Parma, , Italy
Ospedale G. Da Saliceto, Piacenza, , Italy
AOR San Carlo, Potenza, , Italy
Ospedale Degli Infermi, Rimini, , Italy
Policlinico Gemelli, Roma, , Italy
Policlinico Umberto I, Roma, , Italy
Humanitas, Rozzano, , Italy
Casa Sollievo della Sofferenza, San Giovanni Rotondo, , Italy
AOU Città Della Salute e Della Scienza Ematologia Universitaria, Torino, , Italy
AOU Città Della Salute e Della Scienza SC Ematologia, Torino, , Italy
AOU di Udine, Udine, , Italy
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Contact Details
Name: Maurizio Martelli, MD
Affiliation: Policlinico Umberto I - Università "La Sapienza"
Role: PRINCIPAL_INVESTIGATOR
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