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STUDY WITH LENALIDOMIDE (Revlimid®) MAINTENANCE VS OBSERVATION AFTER INTENSIFIED INDUCTION REGIMEN CONTAINING RITUXIMAB FOLLOWED BY HIGH DOSE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL TRANSPLANTATION AS FIRST LINE TREATMENT IN ADULT PATIENTS WITH ADVANCED MANTLE CELL LYMPHOMA

Information source: Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: MANTLE CELL LYMPHOMA

Intervention: Lenalidomide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Fondazione Italiana Linfomi ONLUS

Official(s) and/or principal investigator(s):
Sergio Cortellazzo, MD, Study Director, Affiliation: Division of Hematology and BMT, General Hospital of Bolzano, Italy.

Overall contact:
Daniela Gioia, PhD, Phone: 0131/206066, Email: dgioia@ospedale.al.it

Summary

A phase III multicenter, randomized study with Lenalidomide (Revlimid®) maintenance versus observation after intensified induction regimen containing rituximab followed by high dose chemotherapy and Autologous Stem Cell Transplantation as first line treatment in adult patients with advanced Mantle Cell Lymphoma: IIL study (MCL0208).

Clinical Details

Official title: A PHASE III MULTICENTER, RANDOMIZED STUDY WITH LENALIDOMIDE (Revlimid®) MAINTENANCE VERSUS OBSERVATION AFTER INTENSIFIED INDUCTION REGIMEN CONTAINING RITUXIMAB FOLLOWED BY HIGH DOSE CHEMOTHERAPY AND AUTOLOGOUS STEM CELL TRANSPLANTATION AS FIRST LINE TREATMENT IN ADULT PATIENTS WITH ADVANCED MANTLE CELL LYMPHOMA.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression Free Survival (PFS)

Secondary outcome:

Overall Survival (OS)

Progression Free Survival (PFS)

Disease-free survival (DFS)

Event-free survival (EFS)

Complete Response (CR) Rate

Overall Response Rate (ORR)

Incidence of grade 3 or higher Toxicity measured by CTCAE v.4 at any time during therapy and follow-up.

Quality of life

Detailed description: This is a Phase 3, multicenter, open-label, randomized, controlled study to determine the efficacy and safety of lenalidomide as maintenance therapy versus observation in patients with MCL in complete or partial remission after first line intensified and high-dose chemotherapy additioned with rituximab and followed by ASCT. This study will be conducted in three phases: a Screening Phase, a Treatment Phase and a Follow-up Phase

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria. 1. Any male or female adult with newly diagnosed mantle cell lymphoma according to the WHO criteria. 2. Biopsy-proven mantle cell non-Hodgkin's lymphoma, including evidence of cyclin D1 overexpression or the translocation t(11;14)(q13;q32) by FISH or RT-PCR. In subjects whose tumors are negative for the cyclin D1, evidence of overexpression of cyclin D2 or D3 by immunohistochemistry will be acceptable. 3. Age ≥18 years and < 60 with ECOG performance status 0-3, or an age from 60 to 65 years with an ECOG performance status 0-2, except when PS impairment is related to NHL. 4. Advanced stage (Stage III and IV according to Ann Arbor and stage II with bulky disease defined as a mass ≥ 5 cm or B symptoms). 5. Measurable disease (two diameters) in at least one site. Osteoblastic bone lesions, ascites and pleural effusion are not considered measurable disease. 6. Written informed consent prior to any study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. 7. Be willing and able to comply with the protocol for the duration of the study. 8. Females of childbearing potential (FCBP) must: have two negative medically supervised pregnancy test prior to starting of study therapy. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the patient practices complete and continued sexual abstinence. Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy. The following are effective methods of contraception

- Implant

- Levonorgestrel-releasing intrauterine system (IUS)

- Medroxyprogesterone acetate depot

- Tubal sterilisation

- Sexual intercourse with a vasectomised male partner only; vasectomy must be

confirmed by two negative semen analyses

- Ovulation inhibitory progesterone-only pills (i. e., desogestrel)

9. Male patients must agree to use a condom during sexual contact with a FCBP, even if they have had a vasectomy, throughout study drug therapy, during any dose interruption and after cessation of study therapy. Agree to not donate semen during study drug therapy and for a period after end of study drug therapy. 10. All patients must have an understanding that the study drug could have a potential teratogenic risk. They must agree to abstain from donating blood while taking study drug therapy and following discontinuation of study drug therapy. They must to agree not to share study medication with another person. They must be counseled about pregnancy precautions and risks of fetal exposure. Exclusion Criteria: 1. Non-Hodgkin's lymphoma subtypes other than MCL 2. Cytological variant with small cells with round nuclei mimicking CLL, which is frequently recognized in patients with a leukemic and splenomegaly presentation without or with minimal involvement of lymph nodes and has an indolent clinical course. 3. History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM stage of T1a or T1b) within the last 3 years. 4. Major surgery, other than diagnostic surgery, within the last 4 weeks. 5. Evidence of CNS involvement, patients with an history of uncontrolled seizures, central nervous system disorders or psychiatric disability considered by the Investigator to be clinically significant and adversely affecting compliance to study drugs. If clinically indicated, lumbar puncture, and MRI should be performed during the screening process. 6. Clinically significant cardiac disease (VEF <45%) (e. g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months (New York Heart Association Class III or IV heart disease) and marked impairment of pulmonary function (pulmonary diffusing capacity <50%). 7. Unacceptable hematologic values in the week prior to the start of study: hemoglobin <9 g/dL, WBC <3x109/L, platelets <60x109/L, absolute neutrophil count (ANC)<1. 5x109/L (unless cytopenia is secondary to bone marrow involvement or autoimmune cytopenia related to lymphoma). 8. Abnormal liver function tests, within one week prior to study start above any of the values listed: serum bilirubin > 2 mg/dL, ALT or AST >3 times the upper normal value; alkaline phosphatase>2. 5 times the upper normal value (unless these abnormalities are due to liver involvement of lymphoma). 9. Abnormal renal function (serum creatinine >2. 0 mg/dL), unless it is disease related 10. Patients with active opportunistic infections. 11. Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are seropositive because of hepatitis B virus vaccine are eligible. Patients with HBcAb serology, will not be excluded from the study and be given lamivudine as prophylaxis starting one week before chemotherapy. HbsAg and AST/ALT ifHBV DNA is not available, will be monitored every three weeks. If HBV DNA is available, it will be monitored along with HBsAg 12. Pregnant or lactating females

Locations and Contacts

Daniela Gioia, PhD, Phone: 0131/206066, Email: dgioia@ospedale.al.it

A.O.SS. Biagio, Antonio e Cesare Arrigo, Alessandria, Italy; Recruiting
Alessandro Levis, MD, Principal Investigator

AORN San G.Moscati, Avellino, Italy; Not yet recruiting
Nicola Cantore, MD, Principal Investigator

Centro di riferimento Oncologico - Oncologia Medica A, Aviano (PN), Italy; Not yet recruiting
Mariagrazia Michieli, MD, Principal Investigator

Ematologia con Trapianto, Università di Bari, Bari 70124, Italy; Not yet recruiting
Giorgina Specchia, MD, Principal Investigator

Istituto di Ematologia ed Oncologia Medica A. Seragnoli Policlinico S. Orsola, Bologna 40138, Italy; Not yet recruiting
Pierluigi Zinzani, MD, Principal Investigator

Divisione di Ematologia e TMO, Ospedale di Bolzano, Bolzano 39100, Italy; Recruiting
Sergio Cortelazzo, MD, Principal Investigator

Divisione di Ematologia Spedali Civili, Brescia, Italy; Recruiting
Giuseppe Rossi, MD, Principal Investigator

Divisione di Ematologia Osp.Businco, Cagliari, Italy; Not yet recruiting
Emanuele Angelucci, MD, Principal Investigator
Maria Giuseppina Cabras, MD, Principal Investigator

Università Cattolica Campobasso, Campobasso, Italy; Not yet recruiting
Sergio Storti, MD, Principal Investigator

IRCC Onco-Ematologia, Candiolo (TO), Italy; Not yet recruiting
Massimo Aglietta, PhD, Principal Investigator

Osp.Bufalini Divisione di Medicina, Cesena, Italy; Not yet recruiting
Luciano Guardigni, MD, Principal Investigator

Ospedale di Ciriè U.O.N.A. Oncologia servizio di Ematologia, Ciriè (TO), Italy; Not yet recruiting
Roberto Freilone, MD, Principal Investigator

Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy; Recruiting
Andrea Gallamini, MD, Principal Investigator

Divisione di Ematologia, Policlinico Careggi, Firenze, Italy; Not yet recruiting
Alberto Bosi, MD, Principal Investigator

Ematologia I, A.O.U. San Martino, Genova 16132, Italy; Not yet recruiting
Angelo M Carella, MD, Principal Investigator

Ospedale S Martino, Genova, Italy; Not yet recruiting
Marco Gobbi, MD, Principal Investigator

SC. MED. Trasfusionale ed Ematologia Ospedale Civile, Ivrea (TO), Italy; Not yet recruiting
Mauro Girotto, MD, Principal Investigator

Istituto Vito Fazzi, Lecce, Italy; Not yet recruiting
Nicola Di Renzo, MD, Principal Investigator

Area Vasta Romagna e IRST, Meldola (FC), Italy; Not yet recruiting
Dino Amadori, MD, Principal Investigator

Azienda Ospedaliera Papardo, Messina, Italy; Not yet recruiting
Maura Brugiatelli, MD, Principal Investigator

Divisione di Ematologia, Ospedale Niguarda, Milano 20162, Italy; Recruiting
Livio Gargantini, MD, Principal Investigator

IRCCS San Raffaele Unità di Chamioterapia, Milano, Italy; Not yet recruiting
Andrés J.M.Ferreris, MD, Principal Investigator

Ospedale Maggiore Mangiagalli e Regina Elena, Milano, Italy; Not yet recruiting
Giorgio Lambertenghi Deliliers, Prof., Principal Investigator
Luca Baldini, Prof., Principal Investigator

Azienda Ospedaliera Policlinico, Modena, Italy; Recruiting
Franco Narni, Prof., Principal Investigator

Osp.San Gerardo Divisione di Ematologia, Monza (MI), Italy; Recruiting
Enrico Pogliani, Prof., Principal Investigator
Pietro Enrico Pioltelli, MD, Principal Investigator

AOU Federico II di Napoli, Napoli, Italy; Not yet recruiting
Fabrizio Pane, MD, Principal Investigator

Ospedale San Gennaro, Napoli, Italy; Not yet recruiting
Lucia Mastrullo, MD, Principal Investigator

Ospedale Umberto I - DH Oncoematologico, Nocera Inferiore, Italy; Not yet recruiting
Alfondo D'Arco, MD, Principal Investigator

SCDU Ematologia, AOU Maggiore della Carità, Novara 28100, Italy; Not yet recruiting
Gianluca Gaidano, MD, Principal Investigator

Ospedale S. Francesco, Nuoro, Italy; Not yet recruiting
Attilio Gabbas, MD, Principal Investigator

A.O. di Padova Divisione di Oncologia Medica, Padova, Italy; Not yet recruiting
Savina Anversa, MD, Principal Investigator

Casa di cura La Maddalena Unita' di Ematologia, Palermo, Italy; Not yet recruiting
Maurizio Musso, MD, Principal Investigator

A O Universitaria di Parma, Parma, Italy; Not yet recruiting
Vittorio Rizzoli, MD, Principal Investigator

Fondazione Policlinico San Matteo Clinica Ematologica, Pavia, Italy; Recruiting
Ercole Brusamolino, MD, Principal Investigator

Ospedale Civile G.da Saliceto - UOA Ematologia, Piacenza, Italy; Not yet recruiting
Daniele Vallisa, MD, Principal Investigator
Annalisa Arcari, MD, Principal Investigator

Ospedale S. Chiara Azienda ospedaliera pisana, Pisa, Italy; Not yet recruiting
Mario Petrini, Prof., Principal Investigator

Ospedale San Carlo, Potenza, Italy; Not yet recruiting
Attilio Olivieri, Prof., Principal Investigator

Ausl Ravenna, Ravenna, Italy; Not yet recruiting
Alfonso Zaccaria, MD, Principal Investigator

AO Bianchi Melacrino Morelli UO Ematologia, Reggio Calabria, Italy; Not yet recruiting
Caterina Stelitano, MD, Principal Investigator
Francesco Nobile, MD, Principal Investigator

AO Arcispedale S.Maria Nuova Ematologia, Reggio Emilia, Italy; Recruiting
Francesco Merli, MD, Principal Investigator

Osp. degli Infermi Divisione di Oncologia, Rimini, Italy; Not yet recruiting
Annalisa Molinari, MD, Principal Investigator

Azienda Ospedaliera "S. Camillo - Forlanini", Roma, Italy; Not yet recruiting
Valerio Zoli, MD, Principal Investigator

Ospedale S.Eugenio Ematologia, Roma, Italy; Not yet recruiting
Alessio Perrotti, MD, Principal Investigator

Policlinico A. Gemelli Università Cattolica del Sacro Cuore, Roma, Italy; Not yet recruiting
Giuseppe Leone, PhD, Principal Investigator

Policlinico Universitario Tor Vergata, Roma, Italy; Not yet recruiting
Maria Cantonetti, MD, Principal Investigator
Micaela Ales, MD, Principal Investigator

Universita' La Sapienza, Roma, Italy; Recruiting
Maurizio Martelli, MD, Principal Investigator

Istituto clinco Humanitas, Rozzano (MI), Italy; Recruiting
Armando Santoro, MD, Principal Investigator

Casa sollievo della sofferenza, San giovanni Rotondo, Italy; Not yet recruiting
Nicola Cascavilla, MD, Principal Investigator

Istituto di Ematologia Università degli studi di Sassari, Sassari, Italy; Not yet recruiting
Maurizio Longinotti, PhD, Principal Investigator

AO Universitaria senese, Siena, Italy; Not yet recruiting
Alberto Fabbri, MD, Principal Investigator

Azienda Ospedaliera di Perugia, Terni, Italy; Not yet recruiting
Marina Liberati, MD, Principal Investigator

Osp. San Giovanni Battista_Molinette Ematologia 2, Torino, Italy; Recruiting
Umberto Vitolo, MD, Principal Investigator

San Giovanni Battista Molinette - Biologia Molecolare, Torino, Italy; Not yet recruiting
Marco Ladetto, MD, Principal Investigator

Ospedale Cà Foncello UO Ematologia, Treviso, Italy; Not yet recruiting
Filippo Gherlinzoni, MD, Principal Investigator
Piero Maria Stefani, MD, Principal Investigator

Ospedale Generale Prov. Cardinale G. Panico, Tricase (LE), Italy; Recruiting
Vincenzo Pavone, MD, Principal Investigator

Ospedale Maggiore di Trieste, Trieste, Italy; Not yet recruiting
Gabriele Pozzato, MD, Principal Investigator

AO Universitaria di Udine, Udine, Italy; Not yet recruiting
Francesco Zaja, MD, Principal Investigator

Ospedale dell'Angelo, Mestre, VE, Italy; Not yet recruiting
Teodoro Chisesi, MD, Principal Investigator

Additional Information

Starting date: May 2010
Last updated: February 2, 2015

Page last updated: August 23, 2015

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