Spots Global Cancer Trial Database for Copanlisib With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma
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Trial Identification
Brief Title: Copanlisib With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma
Official Title: Copanlisib in Combination With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma: a Multicentric Phase II Trial
Study ID: NCT04433182
Conditions
Interventions
Study Description
Brief Summary: This is a multicentric single arm phase II trial, to investigate the efficacy (in terms of PFS) of the combination regimen rituximab-bendamustine in association with copanlisib in patients affected by relapsed/refractory DLBCL, not eligible to HDC and ASCT or relapsed after intensified regimens.
Detailed Description: The primary objective of this study is to evaluate the efficacy, in terms of Progression Free Survival (12m-PFS) at 12 months, of a treatment with copanlisib in combination with a standard rituximab-bendamustine regimen in patients with relapsed-refractory DLBCL, who have received at least one, but no more than three lines of treatment, including rituximab-based immunochemotherapy, not eligible for high-dose chemotherapy and ASCT or T-cell CAR-T therapy, or relapsed after these treatments.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ospedale Monsignor Raffaele Dimiccoli - Ematologia, Barletta, Barletta-Andria-Trani, Italy
Centro Riferimento Oncologico - S.O.C. Oncologia Medica A, Aviano, Pordenone, Italy
Ematologia, Candiolo Cancer Institute. FPO-IRCCS, Candiolo, Torino, Italy
AOU Ospedali Riuniti - Clinica di Ematologia, Ancona, , Italy
ASST Spedali Civili - Ematologia, Brescia, , Italy
Arnas Nuovo Ospedale Garibaldi Nesima - U.O.C. Ematologia, Catania, , Italy
A.O. S. Croce e Carle - S.C. di Ematologia e Trapianto di Midollo Osseo, Cuneo, , Italy
Ospedale Vito Fazzi - Ematologia, Lecce, , Italy
Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia, Messina, , Italy
I.R.C.C.S. Istituto Oncologico Veneto - Oncologia 1, Padova, , Italy
AOU Policlinico Giaccone - Ematologia, Palermo, , Italy
IRCCS Policlinico S. Matteo di Pavia - Divisione di Ematologia, Pavia, , Italy
Ospedale Guglielmo da Saliceto - U.O.Ematologia, Piacenza, , Italy
Azienda Ospedaliera Sant'Andrea - Ematologia, Roma, , Italy
Policlinico Umberto I - Università "La Sapienza" Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione, Roma, , Italy
Azienda Ospedaliera S. Maria di Terni - S.C. Oncoematologia, Terni, , Italy
Azienda Ospedaliero Universitaria Città della Salute e della Scienza - S.C.Ematologia, Torino, , Italy
Ospedale Ca' Foncello - S.C di Ematologia, Treviso, , Italy
Contact Details
Name: Umberto Vitolo
Affiliation: Ematologia, Candiolo Cancer Institute. FPO-IRCCS
Role: PRINCIPAL_INVESTIGATOR
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