Spots Global Cancer Trial Database for Phase II Study of Age-Adjusted Rituximab, Bendamustine, Cytarabine as Induction Therapy in Older Patients With MCL
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Trial Identification
Brief Title: Phase II Study of Age-Adjusted Rituximab, Bendamustine, Cytarabine as Induction Therapy in Older Patients With MCL
Official Title: Phase II Study of Age-Adjusted R-BAC (Rituximab, Bendamustine, Cytarabine) as Induction Therapy in Older Patients With Mantle Cell Lymphoma (MCL)
Study ID: NCT01662050
Conditions
Interventions
Study Description
Brief Summary: A phase 2 study of standard R-BAC (rituximab 375 mg/m2, bendamustine 70 mg/m2, ara-c 800 mg/m2) has been recently ultimated at the Vicenza Hematology Department involving several regional centers on both untreated and previously treated patients with Mantle Cell Lymphoma (MCL). An interim analysis conducted on 30 patients showed that rituximab + bendamustine + ara-c combination had very good clinical activity, but a quite relevant hematological toxicity, especially in previously treated and older patients (Visco C, ICML 2011 Lugano Conference, Poster 236). Objectives: The primary objective is to determine the activity (complete remission rate according to Cheson 2007 criteria) and safety of age-adjusted Rituximab-Bendamustine-Cytarabine (RBAC500) regimen at the end of treatment in older untreated patients with MCL. The secondary objectives are to determine: * The rate of molecular response (characterized by labs of the FIL) * The progression-free survival (PFS) * The overall survival (OS) * The duration of responses (DOR) * The rate of patients that complete the expected treatment schedule (6 courses) * The rate of patients that are subject to dose reductions or delays
Detailed Description: Study End points Primary efficacy end point of the study is the proportion of CR defined according to Cheson criteria (2007) at the end of treatment (6 or 4 cycles). Primary safety end point is the occurrence of any of the stop treatment criteria or of any episode of relevant toxicity, as above defined. Secondary end points are MRD defined response, OS, PFS and DOR (Cheson 2007). Molecular response is the proportion of patients with molecular rearrangements at baseline that become negative during treatment, measured by qualitative and quantitative PCR. OS is measured from enrollment until death from any cause. PFS is measured from the time of enrollment until disease progression, relapse or death from any cause. DOR is measured from the first assessment that documents response (CR or PR) to the date of disease relapse or progression. Minimum follow up required for all patients will be 24 months.
Keywords
Eligibility
Minimum Age: 65 Years
Eligible Ages: OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
A.O. Policlinico Consorziale, Bari, BA, Italy
IRCCS Ospedale Oncologico, Bari, BA, Italy
A.O. Spedali Civili, Brescia, BS, Italy
U.O.C. Ematologia Ospedale "San Nicola Pellegrino" ASL BAT, Trani, BT, Italy
Ospedale Businco, Cagliari, CA, Italy
AO Valduce, Como, CO, Italy
U.O.C. Garibaldi Nesima, Catania, CT, Italy
AOU Careggi, Firenze, FI, Italy
A.O.U. San Martino, Genova, GE, Italy
PO Vito Fazzi, Lecce, LE, Italy
Ospedale Cardinale G. Panico, Tricase, LE, Italy
Asur - Zona Territoriale 8, Civitanova Marche, MC, Italy
U.O.C. Ematologia - Policlinico Universitario, Messina, ME, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milano, MI, Italy
A.O. S. Carlo Borromeo di Milano Unità Semplice di Trapianto Midollo - A.O.S.Carlo Borromeo, Milano, MI, Italy
A.O. Niguarda, Milano, MI, Italy
Osp. San Gerardo, Monza, MI, Italy
Istituto Clinico Humanitas, Rozzano, MI, Italy
Centro Oncologico Modenese (COM), Modena, MO, Italy
"La Maddalena", Palermo, PA, Italy
Ospedali Riuniti Villa Sofia - Cervello, Palermo, PA, Italy
Ospedale Civile Guglielmo da Saliceto, Piacenza, PC, Italy
Università di Padova, Padova, PD, Italy
Presidio ospedaliero di Pescara, Pescara, PE, Italy
CRO Aviano, Aviano, PN, Italy
Fondazione IRCCS Policlinico San Matteo,, Pavia, PV, Italy
Osp. S. Maria delle Croci, Ravenna, RA, Italy
Azienda Ospedaliera "Bianchi Melacrino Morelli", Reggio Calabria, RC, Italy
Azienda Ospedaliera Arcispedale "S.Maria Nuova", Reggio Emilia, RE, Italy
A.O. San Camillo Forlanini, Roma, RM, Italy
Nuovo Regina Margherita, Roma, RM, Italy
Università "La Sapienza", Roma, RM, Italy
A.O. S. Giovanni Addolorata, Roma, RM, Italy
Ospedale degli Infermi di Rimini, Rimini, RN, Italy
Azienda ULSS 18, Rovigo, RO, Italy
Osp. Umberto I, Nocera Inferiore, SA, Italy
A.O.U. San Giovanni di Dio e Ruggi d'Aragona, Salerno, SA, Italy
Az. Ospedaliera Univ. Senese, Siena, SI, Italy
ASL TO4, Ciriè-Ivrea-Chivasso, TO, Italy
Ospedale S. Luigi Gonzaga,, Orbassano, TO, Italy
A.O.U. S. Giovanni Battista -Ematologia 2, Torino, TO, Italy
AOU San Giovanni Battista-Ematologia 1, Torino, TO, Italy
A.O. S. Maria di Terni, Terni, TR, Italy
Azienda Ospedaliero - Universitaria di Udine, Udine, UD, Italy
Ospedale di Circolo e Fondazione Macchi - Ematologia, Varese, VA, Italy
Ospedale di Circolo e Fondazione Macchi - Oncologia, Varese, VA, Italy
Osp. S. Andrea Vercelli, Vercelli, VC, Italy
Ospedale Civile di Mirano, Mirano, VE, Italy
Ospedale San Bortolo, Vicenza, VI, Italy
Ospedale Policlinico G.B. Rossi (Borgo Roma) Di Verona, Verona, VR, Italy
A.O. SS. Antonio e Biagio e C. Arrigo, Alessandria, , Italy
Comprensorio sanitario di Bolzano, Bolzano, , Italy
Ospedale Cardarelli, Campobasso, , Italy
A.O. Pugliese-Ciacci, Catanzaro, , Italy
IRST, Meldola, , Italy
Università del Piemonte Orientale - Novara, Novara, , Italy
Contact Details
Name: Carlo Visco, MD
Affiliation: Ospedale ULSS 6 di Vicenza - Ematologia
Role: PRINCIPAL_INVESTIGATOR
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