Bendamustine/Lenalidomide/Rituximab: Combination as a Second-Line Therapy for 1st Relapsed-Refractory MCL
Conditions
Mantle Cell Lymphoma
Conditions: official terms
Lymphoma, Mantle-Cell
Conditions: Keywords
MCL, Mantle Cell Lymphoma, RELAPSED-REFRACTORY
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Bendamustine, Lenalidomide, Rituximab
Type: Drug
Overall Status
Recruiting
Summary
This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Bendamustine, Lenalidomide and Rituximab (R2-B) in patients with first relapsed/refractory mantle cell lymphoma (MCL) and the efficacy and safety of a maintenance treatment with Lenalidomide for 18 months from the end of R2-B (from month 7 to 24) for those responding to the induction.
Detailed Description
This is a phase II study, non randomized, multicenter. Patients with MCL refractory to front line therapy or in first relapse will be enrolled.

The study includes an induction phase, a consolidation phase, a maintenance phase and a follow up phase.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patient has a diagnosis of MCL according to the WHO classification;

- Patient age is ≥ 18 years;

- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2;

- Understands and voluntarily signs an informed consent form;

- Able to adhere to the study visit schedule and other protocol requirements;

- Patients treated with one prior regimen and relapsed, or refractory to front line therapy; front line consolidation with autologous stem cell transplantation is considered to be part of first line therapy;

- Patient has at least one site of measurable nodal disease at baseline ≥ 2.0 cm in the longest transverse diameter as determined by CT scan (MRI is allowed only if CT scan can not be performed). Note: Patients with bone marrow involvement are eligible;

- Adequate haematological counts: ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement by MCL;

- Conjugated bilirubin up to 2 x ULN unless due to liver involvement by MCL;

- Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MCL;

- Creatinine clearance ≥ 30 ml/min; a dose reduction of Lenalidomide for patients with creatinine clearance ≥ 30 mL/min but < 50 mL/min is planned;

- Written informed consent was obtained from the patient prior to any study-specific screening procedures;

- Patient has the ability to swallow capsules or tablets;

- Life expectancy ≥ 6 months;

- Disease free of prior malignancies (a part MCL) with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast;

Exclusion Criteria:

- Patients who have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study;

- Patient has a history of CNS involvement with lymphoma;

- Patients with previous history of malignancies (a part MCL) ≤ 3 years before study accrual with the exception of currently treated basal cell and squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix;

- History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances;

- Patient has any other concurrent severe and/or uncontrolled medical condition(s) (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol;

- Creatinine clearance < 30 ml/min;

- Patient has a known history of HIV seropositivity;

- Patient has active HBV hepatitis. The following categories of HBV positive patients but with non evidence of active hepatitis may be considered for the study and treated with R2-B (see also Section 8.1.8):

- patient is HBsAg + with HBV DNA < 2000 UI/ml (inactive carriers); HBV DNA > 2000 UI/ml is criteria of exclusion;

- patient is HBsAg - HBsAb +;

- patient is HBsAg - but HBcAb +

- Patients with HCV active hepatitis are excluded from the study. Patient with no evidence of active hepatitis and/or advanced chronic liver disease according to liver biopsy or fibro-scan evaluation may be included into the study

- Patients have received previous treatment with either Bendamustine and/or Lenalidomide.
Locations
UOC Ematologia Trani
Trani, Barletta-Andria-Trani (BT), Italy
Status: Recruiting
Contact: Giuseppe Tarantini, M.D. - tarantini-giuseppe@libero.it
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST Meldola
Meldola, Forlì Cesena, Italy
Status: Recruiting
Contact: Pier Paolo Fattori, M.D. - 00390543739100 - p.fattori@irst.emr.it
UO Ematologia e Trapianto Osp. Cardinale G. Panico
Tricase, Lecce, Italy
Status: Not yet recruiting
Contact: Vincenzo Pavone, M.D. - 00390833773111 - salentoematologia@piafondazionepanico.it
Ematologia Istituto Clinico Humanitas
Rozzano, Milano, Italy
Status: Not yet recruiting
Contact: Armando Santoro, Prof - 00390282244080 - armando.santoro@humanitas.it
CRO Aviano
Aviano, Pordenone, Italy
Status: Not yet recruiting
Contact: Michele Spina, M.D. - 00390434659730 - mspina@cro.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
Medicina Interna 2 ad indirizzo Ematologico AOU San Luigi Gonzaga
Orbassano, Torino, Italy
Status: Not yet recruiting
Contact: Giuseppe Saglio, Prof. - 00390119026721 - giuseppe.saglio@unito.it
SC Ematologia AO SS. Antonio e Biagio
Alessandria, Italy
Status: Recruiting
Contact: Alessandro Levis, M.D. - 00390131206262 - alevis@ospedale.al.it
Clinica di ematologia AOU Umberto I Ospedali Riuniti
Ancona, Italy
Status: Not yet 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
SC Ematologia Spedali Civili
Brescia, Italy
Status: Recruiting
Contact: Alessandro Re, M.D. - 00390303995747 - sandrore@aruba.it
Ematologia Ospedale Cardarelli ASREM
Campobasso, Italy
Status: Not yet recruiting
Contact: Gianfranco Giglio, M.D. - 00390874409448 - gianfrancogiglio@alice.it
Oncoematologia Ospedale SS. Anna e Sebastiano
Caserta, Italy
Status: Not yet recruiting
Contact: Antonio Abbadessa, Prof. - 00390823232300 - antonio.abbadessa@tiscali.it
UOC Ematologia Osp. Garibaldi Nesima
Catania, Italy
Status: Not yet recruiting
Contact: Ugo Consoli, M.D. - 00390957595057 - ugo.consoli@tin.it
Azienda Ospedaliera Pugliese Ciaccio Dipartimento oncoematologico
Catanzaro, Italy
Status: Not yet recruiting
Contact: Stefano Molica, M.D. - 00390961883001
Ematologia ‐ Ospedale dell'Annunziata
Cosenza, Italy
Status: Not yet recruiting
Contact: Carlo Gentile, M.D. - 0039098468132 - dr.cgentile@gmail.com
Unità funzionale di Ematologia Azienda Ospedaliera Universitaria Careggi
Firenze, Italy
Status: Not yet recruiting
Contact: Alberto Bosi, Prof. - 00390557947476 - abosi@unifi.it
Clinica Ematologica AOU San Martino
Genova, Italy
Status: Not yet recruiting
Contact: Filippo Ballerini, M.D. - 00390105552645 - ballerini@unige.it
Ematologia 1 Ospedale S. Martino
Genova, Italy
Status: Recruiting
Contact: Angelo Michele Carella, Prof. - 00390105137321 - angelomichele.carella@hsanmartino.it
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
UOC Ematologia Universitaria Polo Pontino Sapienza
Latina, Italy
Status: Not yet recruiting
Contact: Giuseppe Cimino, Prof. - 003907736556249 - cimino@bce.uniroma1.it
SC Ematologia Azienda Ospedali Riuniti Papardo Piemonte
Messina, Italy
Status: Recruiting
Contact: Maura Brugiatelli, Prof.ssa - 00390903992246 - mbrugiat@tiscali.it
UOC Ematologia Policlinico Universitario AOU G. Martino
Messina, Italy
Status: Not yet recruiting
Contact: Caterina Musolino, Prof.ssa - 0039090344305 - cmusolino@unime.it
SC Ematologia AO Niguarda Cà Granda
Milano, Italy
Status: Not yet recruiting
Contact: Enrica Morra, Prof.ssa - 0264442668 - enrica.morra@ospedaleniguarda.it
SC Ematologia ‐ Trapianto di midollo osseo Fond. IRCCS Istituto Nazionale Tumori
Milano, Italy
Status: Not yet recruiting
Contact: Paolo Corradini, Prof. - 00390223902950 - paolo.corradini@unimi.it
Centro oncoematologico AOU Policlinico
Modena, Italy
Status: Not yet recruiting
Contact: Stefano Luminari, M.D. - 00390594223165 - sluminari@unimore.it
SCDU Ematologia ‐ Università del Piemonte Orientale
Novara, Italy
Status: Recruiting
Contact: Gianluca Gaidano, Prof. - 00390321660663
Ematologia e Immunologia Clinica, Dipartimento di Medicina Università di Padova
Padova, Italy
Status: Not yet recruiting
Contact: Giampiero Semenzato, Prof. - 00390498212298 - g.semenzato@unipd.it
Divisione di Ematologia, Azienda Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy
Status: Recruiting
Contact: Caterina Patti, M.D. - 00390916884002 - k.patti@ospedaliriunitipalermo.it
Oncoematologia Dipartimento oncologico La Maddalena
Palermo, Italy
Status: Not yet recruiting
Contact: Maurizio Musso, M.D. - 00390916806801 - mamusso@libero.it
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: Recruiting
Contact: Luca Arcaini, M.D. - 00390382503595 - luca.arcaini@unipv.it
Unità Ematologia Ospedale Civile di Piacenza
Piacenza, Italy
Status: Recruiting
Contact: Annalisa Arcari, M.D. - 00390523303737 - a.arcari@ausl.pc.it
UO Ematologia Az Ospedaliera Pisana Ospedale "S.Chiara"
Pisa, Italy
Status: Not yet recruiting
Contact: Mario Petrini, Prof. - 0039050992755
UOC Ematologia con TMO Ospedale San Carlo
Potenza, Italy
Status: Not yet recruiting
Contact: Michele Pizzuti, M.D. - 00390971612466 - pizzuti.m@tiscali.it
UO Ematologia Ospedale Santa Maria delle Croci
Ravenna, Italy
Status: Recruiting
Contact: Claudia Cellini, M.D - 00390544286223 - c.cellini@ausl.ra.it
Divisione di Ematologia AO Bianchi Melacrino Morelli
Reggio Calabria, Italy
Status: Recruiting
Contact: Caterina Stelitano, M.D. - 0965397222 - cstelit@libero.it
SC Ematologia AO Santa Maria Nuova IRCCS
Reggio Emilia, Italy
Status: Recruiting
Contact: Francesco Merli, M.D. - 00390522296618 - merli.francesco@asmn.re.it
UO Oncoematologia ospedale degli Infermi
Rimini, Italy
Status: Not yet recruiting
Contact: Annalia Molinari, M.D. - 00390541705987 - annalia.molinari@auslrn.net
Ematologia Ospedale S.Camillo Forlanini
Roma, Italy
Status: Recruiting
Contact: Roberta Battistini, M.D. - rbattistini@scamilloforlanini.rm.it
Ematologia Ospedale San Eugenio
Roma, Italy
Status: Not yet recruiting
Contact: Alessio Perrotti, M.D. - 00390651008988 - alessioperrotti@gmail.com
Ematologia Università La Sapienza
Roma, Italy
Status: Recruiting
Contact: Maurizio Martelli, M.D. - 003906857951 - martelli@bce.uniroma1.it
UOC Ematologia AO San Giovanni Addolorata
Roma, Italy
Status: Not yet recruiting
Contact: Luciana Annino, Prof - 00390677055449 - lannino@hsangiovanni.roma.it
UOC Ematologia e Trapianto Istituto Regina Elena (IFO)
Roma, Italy
Status: Not yet recruiting
Contact: Maria Concetta Petti, M.D. - 0652665685 - mcpetti@ifo.it
Ematologia e Trapianti A.O. San Giovanni di DIO e Ruggi D'Aragona
Salerno, Italy
Status: Not yet recruiting
Contact: Carmine Selleri, Prof - 0039089673150 - cselleri@unisa.it
Ematologia Ospedale SG Moscati
Taranto, Italy
Status: Not yet recruiting
Contact: Maria Rosaria Specchia, M.D. - 00390994786796 - mrosariaspecchia@libero.it
SC Oncoematologia con autotrapianto AO Santa Maria
Terni, Italy
Status: Recruiting
Contact: Anna Marina Liberati, Prof - 0744/205971 - marinal@unipg.it
Ematologia 1 AO Città della Salute e della Scienza
Torino, Italy
Status: Not yet recruiting
Contact: Marco Ladetto, M.D. - 0116334264 - marco.ladetto@unito.it
Ematologia 2 AO Città della Salute e della Scienza
Torino, Italy
Status: Recruiting
Contact: Barbara Botto, M.D. - bbotto@molinette.piemonte.it
Clinica Ematologica Azienda Ospedaliero - Universitaria
Udine, Italy
Status: Recruiting
Contact: Francesco Zaja, M.D. - 00390432559604 - zaja.francesco@aoud.sanita.fgv.it
Oncologia Medica Varese Ospedale di Circolo e Fondazione Macchi
Varese, Italy
Status: Not yet recruiting
Contact: Graziella Pinotti, M.D. - 00390332278556 - graziella.pinotti@ospedale.varese.it
UO Ematologia Ospedale di Circolo e Fondazione Macchi
Varese, Italy
Status: Recruiting
Contact: Francesco Passamonti, M.D. - 00390332393675 - francesco.passamonti@ospedale.varese.it
Start Date
April 2012
Completion Date
April 2017
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