Spots Global Cancer Trial Database for A Phase II Study of the FIL on Elderly Frail Patients With DLBCL
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Trial Identification
Brief Title: A Phase II Study of the FIL on Elderly Frail Patients With DLBCL
Official Title: A Combination of Lenalidomide and Rituximab as Front Line Therapy for the Treatment of Elderly Frail Patients Evaluated in CGA With Diffuse Large B-cells Non-Hodgkin Lymphoma. A Phase II Study of the Fondazione Italiana Linfomi (FIL)
Study ID: NCT02955823
Interventions
Study Description
Brief Summary: A phase II study to evaluate the combination of Lenalidomide and Rituximab as front line therapy for the treatment of elderly frail patients evaluated in CGA with Diffuse Large B-cells non-Hodgkin Lymphoma.
Detailed Description: This is a prospective, multicenter, single arm, phase II trial in elderly patients (≥ 70 years) affected by DLBCL defined as frail according to CGA and previously untreated. The primary endpoint is to evaluate the efficacy of the R2 (Revlimid+Rituximab) combination in first line DLBCL patients not candidate for the standard R-CHOP (or R-CHOP like) treatments due to the frail status.
Eligibility
Minimum Age: 70 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) - Ematologia, Meldola, Forlì-Cesena, Italy
A.O. C. Panico - U.O.C Ematologia e Trapianto, Tricase, Lecce, Italy
Azienda Ospedaliera Arcispedale Santa Maria Nuova - IRCCS - Ematologia, Reggio nell'Emilia, Reggio Emilia, Italy
Ospedale Dell'Angelo - U.O. Ematologia, Mestre, Venezia, Italy
Clinica di Ematologia A.O.Universitaria Ospedali Riuniti, Ancona, Ancona, , Italy
A.O. Spedali Civili di Brescia - Ematologia, Brescia, , Italy
IRCCS AOU S. Martino - IST - Clinica Ematologica, Genova, , Italy
Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia, Messina, , Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Azienda Ospedaliero - Universitaria Policlinico di Modena - Dipartimento di Medicina Diagnostica, Clinica e di Sanità Pubblica, Modena, , Italy
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1, Padova, , Italy
AOU di Parma - U.O. Complessa di Ematologia, Parma, , Italy
Ospedale Guglielmo da Saliceto - U.O.Ematologia, Piacenza, , Italy
Ospedale delle Croci - Ematologia, Ravenna, , Italy
Ospedale degli Infermi di Rimini - U.O. di Ematologia, Rimini, , Italy
Policlinico Universitario Campus Bio-Medico - Area Ematologia Trapianto Cellule Staminali Medicina Trasfusionale e Terapia cellulare, Roma, , Italy
Univ. Perugia Sede Terni - Oncoematologia, Terni, , Italy
Ospedale ULSS 6 di Vicenza - Ematologia, Vicenza, , Italy
Contact Details
Name: Guido Gini, MD
Affiliation: Clinica di Ematologia A.O.Universitaria Ospedali Riuniti, Ancona
Role: PRINCIPAL_INVESTIGATOR
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