A Phase III Multicenter, Randomized Study Comparing Consolidation With 90yttrium-Labeled Ibritumomab Tiuxetan (Zevalin®) Radioimmunotherapy Versus Autologous Stem Cell Transplantation (ASCT) in Patients With Relapsed Follicular Lymphoma (FL)
Conditions
Relapsed Follicular Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Follicular
Conditions: Keywords
Relapsed follicular Lymphoma, RIT, Zevalin
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: ZEVALIN Type: Other
Name: BEAM Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Age 18-65

- Histologically documented diagnosis of grade I-IIIa FL defined according to WHO guidelines 2008 (Re-biopsy required)

- Availability of BM and PB for Minimal Residual Disease (MRD) analysis (see Appendix I)

- Relapsed or refractory disease after ≤ two chemotherapy lines at least one containing Rituximab (Rituximab maintenance is UNOTU considered a therapeutic line)

- Clinical indication of treatment i.e. Stage II-IV who require therapy according to SIE and GELF criteria (see Appendix II)

- ECOG performance status 0-2 (unless disease-related) (see Appendix III)

- Availability of histological material for centralized revision

- Laboratory values:

- ANC ≥ 1500/mmc unless due to marrow involvement by lymphoma and/or platelets ≥ 100000/mmc unless due to marrow involvement by lymphoma

- Serum creatinine ≤ 1.5 x ULN, unless it is disease related

- Bilirubin ≤ 1.5 x ULN (or ≤ 3.0 x ULN, if patient has Gilbert syndrome)

- AST/SGOT and/or ALT/SGPT ≤ 2.5 x ULN if not lymphoma related or ≤ 5.0 x ULN in case of lymphoma liver involvement

- Adequate cardiac function: LVEF > 50% by echocardiography or MUGA scan

- Not pregnant or breast-feeding

- Willingness to use effective contraception during the study and 3 months after the end of treatment

- No other prior malignancies except for adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix, or other cancer from which the patient has been disease-free for ≥ 5 years (see Exclusion criteria 14)

- Signed informed written consent

Exclusion Criteria:

- Grade IIIb FL, transformed FL or histologies different from FL

- Previous treatment with > two lines of chemotherapy ± rituximab Maintenance is UNOTU considered a therapeutics line)

- Previous ASCT or RIT treatment

- CNS involvement by lymphoma

- HBV positivity with the exception of patients who are seropositive because of hepatitis B virus vaccination and patients HbcAb positive and HbsAg negative with undetectable serum HBV-DNA. Occult carriers: must receive treatment with Lamivudine 100 mg for the duration of treatment program and at least 12 months after treatment cessation; HBV-DNA levels and HBsAg will be monitored every month

- HCV positivity with elevated transaminases or INR or APTT or active virus replication

- HIV positivity

- Any concurrent medical condition requiring long term use (> one month) of systemic corticosteroids

- Active bacterial, viral, or fungal infection requiring systemic therapy

- Any concurrent medical or psychiatric condition which might impair administration of therapy or preclude the ability to give informed consent

- Treatment with an experimental agent within 30 days prior to study entry

- Myelosuppressive chemo or biological therapy within three weeks before study entry (use rituximab course delivered as maintenance is not an exclusion therapy)

- Major surgery other than diagnosis within 4 weeks prior to study entry
Locations
U.O. Oncologia Presidio Ospedaliero N. Giannettasio
Rossano, Cosenza, Italy
Status: Not yet recruiting
A.O.U. San Martino
Genova, GE, Italy
Status: Not yet recruiting
Contact: Angelo Michele Carella, MD - +39 010-513731 - angelomichele.carella@hsanmartino.it
Ematologia, A.O. San Gerardo
Monza, Milano, Italy
Status: Not yet recruiting
A.O. Niguarda
Milano, MI, Italy
Status: Recruiting
Contact: Chiara Rusconi, MD - +39 02 - 64442668 - chiara.rusconi@ospedaleniguarda.it
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milano, MI, Italy
Status: Not yet recruiting
Contact: Luca Baldini, MD - +39 02 - 55033334/3462 - lubaldini@policlinico.mi.it
IRCCS‐Centro di riferimento oncologico UO di ematologia e Trapianto Cellule Staminali
Rionero in Vulture, Potenza, Italy
Status: Recruiting
Contact: Pellegrino Musto, M.D. - 00390972726729 - p.musto@crob.it
Azienda Ospedaliera "Bianchi Melacrino Morelli"
Reggio Calabria, RC, Italy
Status: Not yet recruiting
Contact: Caterina Stelitano, MD - +39 0522-296618 - cstelit@libero.it; elkis862@libero.it
Osp. Umberto I
Nocera Inferiore, SA, Italy
Status: Not yet recruiting
Contact: Alfonso M. D'Arco, MD - +39 081-9213370 - medint.nocera@libero.it
AOU San Giovanni Battista-Ematologia 1
Torino, TO, Italy
Status: Not yet recruiting
Contact: Marco Ladetto, MD - +39 011-6334264 - marco.ladetto@unito.it;antonella.fiorillo@yahoo.it
A.O. S. Maria di Terni
Terni, TR, Italy
Status: Not yet recruiting
Contact: Anna Marina Liberati, MD - +39 0744-205971 - marinal@unipg.it;appolloniviviana@gmail.com
Ospedale San Bortolo
Vicenza, VI, Italy
Status: Recruiting
Ospedale Policlinico G.B. Rossi (Borgo Roma) Di Verona
Verona, VR, Italy
Status: Not yet recruiting
A.O. SS. Antonio e Biagio e C. Arrigo
Alessandria, Italy
Status: Recruiting
Contact: Flavia Salvi, MD - +39 0131206294 - segreteria@filinf.it
Clinica di ematologia AOU Umberto I Ospedali Riuniti
Ancona, Italy
Status: Recruiting
Contact: Guido Gini, M.D - 00390713580384 - g.gini@ospedaliriuniti.marche.it
Ematologia con Trapianto Policlinico Universitario Consorziale
Bari, Italy
Status: Not yet recruiting
Contact: Giorgina Specchia, Prof.ssa - 00390805593471 - g.specchia@ematba.uniba.it
Istituto di Ematologia ed Oncologia Medica A. Seragnoli Policlinico S. Orsola
Bologna, Italy
Status: Not yet recruiting
Ospedale di Bolzano Divisione di Ematologia e Centro Trapianti di Midollo Osseo
Bolzano, Italy
Status: Not yet recruiting
Spedali Civili
Brescia, Italy
Status: Recruiting
Contact: Alessandra Tucci, MD - +39 030/3996269
Presidio Ospedaliero A.Perrino - Divisione di Ematologia
Brindisi, Italy
Status: Not yet recruiting
Divisione di Ematologia Osp. Businco
Cagliari, Italy
Status: Recruiting
IRCC Onco-Ematologia
Candiolo (TO), Italy
Status: Not yet recruiting
Ospedale Garibaldi-Nesima
Catania, Italy
Status: Not yet recruiting
A.O. Pugliese-Ciacci
Catanzaro, Italy
Status: Not yet recruiting
Contact: Stefano Molica, MD - +39 0961-883001 - smolica@libero.it
Ematologia ‐ Ospedale dell'Annunziata
Cosenza, Italy
Status: Not yet recruiting
Contact: Carlo Gentile, M.D. - 0039098468132 - dr.cgentile@gmail.com
Policlinico Careggi Clinica Ematologica
Firenze, Italy
Status: Not yet recruiting
A.O. Universitaria Ospedali Riuniti di Foggia
Foggia, Italy
Status: Not yet recruiting
Azienda Universitaria San Martino
Genova, Italy
Status: Not yet recruiting
S.C. Medicina Trasfusionale ed Ematologia , P.O. Ivrea
Ivrea, Italy
Status: Not yet recruiting
UO Ematologia con trapianto Ospedale Santa Maria Goretti
Latina, Italy
Status: Not yet recruiting
Contact: Angelo De Blasio, M.D. - 003907736553710 - emato@online.latina.it
A O Papardo
Messina, Italy
Status: Not yet recruiting
UOC Ematologia Policlinico Universitario AOU G. Martino
Messina, Italy
Status: Not yet recruiting
Contact: Caterina Musolino, Prof.ssa - 0039090344305 - cmusolino@unime.it
Ematologia e Trapianto IRCCS, Istituto Nazionale dei Tumori
Milano, Italy
Status: Not yet recruiting
IRCCS San Raffaele Unità di Chamioterapia
Milano, Italy
Status: Not yet recruiting
Policlinico di Modena - Università degli studi
Modena, Italy
Status: Not yet recruiting
Istituto Pascale Oncoematologia
Napoli, Italy
Status: Recruiting
SCDU Ematologia ‐ Università del Piemonte Orientale
Novara, Italy
Status: Recruiting
Contact: Gianluca Gaidano, Prof. - 00390321660663
Ospedale S. Francesco
Nuoro, Italy
Status: Recruiting
Ospedale San Luigi Gonzaga Divisione di Ematologia
Orbassano (TO), Italy
Status: Not yet recruiting
Azienda Ospedaliera
Padova, Italy
Status: Not yet recruiting
AO Universitaria Paolo Giaccone
Palermo, Italy
Status: Not yet recruiting
Azienda Ospedaliera V. Cervello
Palermo, Italy
Status: Not yet recruiting
U.O. Complessa di Ematologia Ospedale di Parma
Parma, Italy
Status: Not yet recruiting
Contact: Franco Aversa, Prof. - 00390521903263 - franco.aversa@unipr.it
Ematologia Policlinico San Matteo
Pavia, Italy
Status: Not yet recruiting
Contact: Luca Arcaini, M.D. - 00390382503595 - luca.arcaini@unipv.it
Ospedale Santa Maria della Misericordia
Perugia, Italy
Status: Not yet recruiting
Ospedale Santo Spirito Dipartimento di Ematologia
Pescara, Italy
Status: Not yet recruiting
Unità Ematologia Ospedale Civile di Piacenza
Piacenza, Italy
Status: Recruiting
Contact: Annalisa Arcari, M.D. - 00390523303737 - a.arcari@ausl.pc.it
UOC Ematologia con TMO Ospedale San Carlo
Potenza, Italy
Status: Not yet recruiting
Contact: Michele Pizzuti, M.D. - 00390971612466 - pizzuti.m@tiscali.it
Ausl Ravenna
Ravenna, Italy
Status: Recruiting
SC Ematologia AO Santa Maria Nuova IRCCS
Reggio Emilia, Italy
Status: Recruiting
Contact: Francesco Merli, M.D. - 00390522296618 - merli.francesco@asmn.re.it
A.O.S.Andrea Reparto di Ematologia e Immunoematologia
Roma, Italy
Status: Not yet recruiting
Ematologia Ospedale San Eugenio
Roma, Italy
Status: Not yet recruiting
Contact: Alessio Perrotti, M.D. - 00390651008988 - alessioperrotti@gmail.com
Univeristà La Sapienza
Roma, Italy
Status: Recruiting
Università Cattolica del Sacro Cuore
Roma, Italy
Status: Not yet recruiting
Clinica Humanitas
Rozzano (MI), Italy
Status: Not yet recruiting
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo (FG), Italy
Status: Not yet recruiting
Stabilimento SS. Annunziata
Taranto, Italy
Status: Not yet recruiting
A.O.San Giovanni Battista
Torino, Italy
Status: Recruiting
ASL BAT 1 Divsione di Ematologia
Trani, Italy
Status: Not yet recruiting
Ospedale S. Chiara
Trento, Italy
Status: Not yet recruiting
UO Ematologia Osp. Cardinale Panico
Tricase (LE), Italy
Status: Not yet recruiting
AO Universitaria clinica Ematologica ed Unità terapie Cellulari Carlo Melzi
Udine, Italy
Status: Not yet recruiting
Start Date
June 2012
Completion Date
January 2018
Sponsors
Fondazione Italiana Linfomi ONLUS
Source
Fondazione Italiana Linfomi ONLUS
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page