Spots Global Cancer Trial Database for A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)
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Trial Identification
Brief Title: A Phase III Multicenter, Randomized Study Comparing RIT Vs ASCT in Patients With Relapsed/Refractory (FL)
Official Title: A Phase III Multicenter,Randomized Study Comparing Consolidation With 90yttrium-Labeled Ibritumomab Tiuxetan (Zevalin®) Radioimmunotherapy Vs Autologous Stem Cell Transplantation (ASCT) in Patients With Relapsed/Refractory Follicular Lymphoma (FL) Aged 18-65 Years
Study ID: NCT01827605
Conditions
Study Description
Brief Summary: This is a Phase III, multicenter, open-label, randomized and controlled study to compare the efficacy of a consolidation therapy with RIT versus ASCT in patients with FL in CR or PR after second or third line chemotherapy supplemented with rituximab.
Detailed Description: This is a Phase III, multicenter, open-label, randomized and controlled study to compare the efficacy of a consolidation therapy with RIT vs. ASCT in patients with FL in CR or PR after second or third line chemotherapy supplemented with rituximab. Patients with FL will be eligible for screening at the time of relapsed or refractory disease after two or less chemotherapy lines at least one containing rituximab. This study will be conducted in six steps as follows. Screening Phase, Enrolment and Induction chemotherapy (STEP I) Randomization (STEP II) Stem cell mobilization and collection (STEP III) Consolidation (RIT vs ASCT) (STEP IV) Maintenance (STEP V) Follow-up Phase (STEP VI)
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
A.O.U. San Martino, Genova, GE, Italy
Ematologia, A.O. San Gerardo, Monza, Milano, Italy
A.O. Niguarda, Milano, MI, Italy
IRCCS-Centro di riferimento oncologico UO di ematologia e Trapianto Cellule Staminali, Rionero in Vulture, Potenza, Italy
Azienda Ospedaliera "Bianchi Melacrino Morelli", Reggio Calabria, RC, Italy
Presidio Ospedaliero "A. Tortora", Pagani, SA, Italy
Emat Univ - Città della salute e della scienza di Torino, Torino, TO, 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
Clinica di ematologia AOU Umberto I Ospedali Riuniti, Ancona, , Italy
Ematologia con Trapianto Policlinico Universitario Consorziale, Bari, , Italy
Spedali Civili, Brescia, , Italy
Presidio Ospedaliero A.Perrino - Divisione di Ematologia, Brindisi, , Italy
Divisione di Ematologia Osp. Businco, Cagliari, , Italy
IRCC Onco-Ematologia, Candiolo, , Italy
Ospedale Ferrarotto, Catania, , Italy
Policlinico Careggi Clinica Ematologica, Firenze, , Italy
A O Papardo, Messina, , Italy
Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori, Milano, , Italy
IRCCS San Raffaele Unità di Chemioterapia, Milano, , Italy
Policlinico di Modena - Università degli studi, Modena, , Italy
Istituto Pascale Oncoematologia, Napoli, , Italy
SCDU Ematologia - Università del Piemonte Orientale, Novara, , Italy
Ospedale S. Francesco, Nuoro, , Italy
Azienda Ospedaliera V. Cervello, Palermo, , Italy
U.O. Complessa di Ematologia Ospedale di Parma, Parma, , Italy
Ematologia Policlinico San Matteo, Pavia, , Italy
Ospedale Santa Maria della Misericordia, Perugia, , Italy
Ospedale Santo Spirito Dipartimento di Ematologia, Pescara, , Italy
Unità Ematologia Ospedale Civile di Piacenza, Piacenza, , Italy
Ausl Ravenna, Ravenna, , Italy
SC Ematologia AO Santa Maria Nuova IRCCS, Reggio Emilia, , Italy
Univeristà La Sapienza, Roma, , Italy
SC Ematologia Città della salute e della scienza di Torino, Torino, , Italy
Filippo Gherlizoni, Treviso, , Italy
UO Ematologia Osp. Cardinale Panico, Tricase, , Italy
Clinica di Ematologia - A.O.U. S. Maria di Udine, Udine, , Italy
Contact Details
Name: Umberto Vitolo
Affiliation: AO Città della salute e della Scienza di Torino - Ospedale S. Giovanni Battista - TORINO
Role: PRINCIPAL_INVESTIGATOR
Name: Marco Ladetto
Affiliation: AO SS. Antonio e Biagio e Cesare Arrigo Alessandria
Role: PRINCIPAL_INVESTIGATOR
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