Spots Global Cancer Trial Database for Rituximab, Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL
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Trial Identification
Brief Title: Rituximab, Bendamustine and Cytarabine Followed by Venetoclax in High Risk Elderly Patients With MCL
Official Title: Rituximab, Bendamustine and Cytarabine Followed by Venetoclax (V-RBAC) in High-risk Elderly Patients With Mantle Cell Lymphoma (MCL)
Study ID: NCT03567876
Conditions
Interventions
Study Description
Brief Summary: Prospective, multicenter, phase II trial designed to evaluate whether the addition of Venetoclax after rituximab, bendamustine and cytarabine (R-BAC) to high risk patients with mantle cell lymphoma improves the results of the standard R-BAC, in terms of Progression Free Survival.
Detailed Description: The aim of the study is to improve long term results of R-BAC, consolidating patients with high-risk (HR) features (defined as: elevated Ki67 and/or blastoid cytology and/or TP53 mutation after central pathology review) with Venetoclax (ABT-199), which has demonstrated relevant single agent activity in relapsed/refractory MCL in a Phase 1-2 trial. The updated Progression Free Survival curves of the R-BAC500 trial has shown that the expected 2-years PFS for patients with HR disease is 40% (H0), as compared to low-risk patients (LR) that have a 2-years PFS of 100%. The addition of Venetoclax to HR patients after R-BAC is expected to improve results and efficacy of this regimen in this "difficult -to- treat" population, that represents approximately 40-45 % of newly diagnosed elderly patients with MCL. It appears reasonable to treat with the experimental drug also LR patients that do not respond appropriately (less than CR) at the end of R-BAC. Since the number of such LR patients is hardly predictable based on the present experience with R-BAC500 trial, the analysis of this sub-cohort will be of exploratory nature, and thus assessed separately. The study objective is to evaluate whether the addition of venetoclax after R-BAC to HR patients improves the results of the standard R-BAC, in terms of Progression Free Survival .
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
A.O. SS. Antonio e Biagio e Cesare Arrigo, SC Ematologia, Alessandria, , Italy
Università Politecnica delle Marche, Clinica di Ematologia, Ancona, , Italy
Centro Riferimento Oncologico, S.O.C. Oncologia Medica A, Aviano, , Italy
IRCCS Istituto Tumori Giovanni Paolo II, UOC Ematologia, Bari, , Italy
Policlinico S. Orsola-Malpighi, Istituto di Ematologia "Seragnoli", Bologna, , Italy
ASST Spedali Civili, Ematologia, Brescia, , Italy
Ospedale Businco, Ematologia, Cagliari, , Italy
Azienda Ospedaliera S. Croce e Carle, SC Ematologia, Cuneo, , Italy
Azienda Ospedaliera Universitaria Careggi, Unità funzionale di Ematologia, Firenze, , Italy
Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia, Clinica Ematologica, Genova, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Ematologia, Meldola, , Italy
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia, Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Ematologia, Milano, , Italy
Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia, Milano, , Italy
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca' Granda, Ematologia, Milano, , Italy
AOU Maggiore della Carità di Novara, SCDU Ematologia, Novara, , Italy
Azienda Ospedaliera Universitaria di Padova, Ematologia, Padova, , Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia, Palermo, , Italy
IRCCS Policlinico S. Matteo, Divisione di Ematologia, Pavia, , Italy
Ospedale Guglielmo Da Saliceto, UO Ematologia, Piacenza, , Italy
Ospedale delle Croci, Ematologia, Ravenna, , Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli, Ematologia, Reggio Calabria, , Italy
Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia, Reggio Emilia, , Italy
Ospedale degli Infermi, UO Ematologia, Rimini, , Italy
Policlinico Umberto I - Università "La Sapienza", Istituto Ematologia -Dipartimento di Biotecnologie Cellulari ed Ematologia, Roma, , Italy
Università Cattolica S. Cuore, Ematologia, Roma, , Italy
Istituto Clinico Humanitas, UO Ematologia, Rozzano, , Italy
A.O.U. Città della Salute e della Scienza di Torino, SC Ematologia Universitaria, Torino, , Italy
A.O.U. Città della Salute e della Scienza di Torino, SC Ematologia, Torino, , Italy
Ospedale Ca' Foncello, SC Ematologia, Treviso, , Italy
Azienda Ospedaliera C. Panico, UOC Ematologia e Trapianto, Tricase, , Italy
Azienda Sanitaria Universitaria Integrata di Udine, Clinica Ematologica, Udine, , Italy
Ospedale di Circolo, UOC Ematologia, Varese, , Italy
Azienda Ospedaliera Universitaria Integrata di Verona, UO Ematologia, Verona, , Italy
Ospedale San Bortolo, Divisione di Ematologia, Vicenza, , Italy
Contact Details
Name: Carlo Visco, MD
Affiliation: AOU Integrata di Verona - U.O. Ematologia -Verona -Italy
Role: PRINCIPAL_INVESTIGATOR
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