Spots Global Cancer Trial Database for GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma
Official Title: GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma A Phase II Study of the Fondazione Italiana Linfomi (FIL)
Study ID: NCT02495454
Interventions
Study Description
Brief Summary: GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell non-Hodgkin's lymphoma.
Detailed Description: Considering that the treatment of elderly unfit patients with DLBCL cannot be based on a full course of R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone), and that using a less intense R-miniCHOP (an attenuated version of the standard R-CHOP: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) combination an acceptable cure rate can be achieved this study is designed to try to improve the cure rate in unfit patients with DLBCL (Diffuse Large B Cell Lymphoma) by adopting the R-miniCHOP scheme substituting Rituximab with the more active GA101 monoclonal antibody. The study hypothesis is that a higher activity of the treatment can be achieved without modifying the cytotoxic part of the treatment but using a more active immunotherapy. Differently from the previous experience with R-miniCHOP eligible patient are not only identified using anagraphic criteria but adopting CGA (Comprehensive Geriatric Assessment) as part of initial assessment and considering as eligible unfit patients.
Keywords
Eligibility
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
A.O. Spedali Civili, Brescia, BS, Italy
AUSL di Ravenna, Ravenna, RA, Italy
Asmn-Irccs, Reggio Emilia, RE, Italy
Ematologia 1U - AO Città della Salute e della Scienza, Torino, TO, Italy
A.O. S. Maria di Terni, Terni, TR, Italy
A.O. SS. Antonio e Biagio e C. Arrigo, Alessandria, , Italy
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona, Ancona, , Italy
A.O. Ospedale Degli Infermi, Biella, , Italy
Area Vasta Romagna e IRST, Meldola (FC), , Italy
IRCCS, Istituto Nazionale dei Tumori, Milano, , Italy
A.O. Universitaria Policlinico Di Modena, Modena, , Italy
SCDU Ematologia - Università del Piemonte Orientale, Novara, , Italy
Irccs Istituto Oncologico Veneto (Iov), Padova, , Italy
Oncoematologia e TMO Dopartimento Oncologia La Maddalena, Palermo, , Italy
Ausl Di Rimini, Rimini, , Italy
Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI, Varese, , Italy
Contact Details
Name: Francesco Merli, MD
Affiliation: Ematologia - IRCCS Arcispedale Santa Maria Nuova
Role: PRINCIPAL_INVESTIGATOR
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