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A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Information source: Celgene Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mantle Cell Lymphoma; Lymphoma, Mantle-Cell

Intervention: Lenalidomide (Drug); Investigators choice single agent (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Celgene Corporation

Official(s) and/or principal investigator(s):
Marek Trneny, MD/PhD/Prof, Principal Investigator, Affiliation: Head, Ist Dept Medicine, Charles University Hospital; Director, Institute of Hematology and Blood Transfusion; Chair, Czech Lymphoma Study Group

Summary

To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory Mantle Cell Lymphoma.

Clinical Details

Official title: A PHASE 2, MULTICENTER, RANDOMIZED OPEN-LABEL STUDY TO DETERMINE THE EFFICACY OF LENALIDOMIDE (REVLIMID®) VERSUS INVESTIGATOR'S CHOICE IN PATIENTS WITH RELAPSED OR REFRACTORY 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 response rate

Duration of response

Tumor control rate

Time to progression

Time to treatment failure

Time to tumor response

Overall survival

Safety

Quality of Life

Detailed description: This research study is for patients who have relapsed or refractory mantle cell lymphoma following treatment such as radiotherapy, immunotherapy, chemotherapy, or radioimmunotherapy. Currently, there is no clearly recommended standard treatment in this population. Chemotherapy agents such as gemcitabine, cytarabine, chlorambucil, fludarabine, or the immunotherapeutic agent, rituximab, may be proposed. Thus, the aim is to search for new treatments that may improve the prognosis of patients with relapsed mantle cell lymphoma. The present clinical study aims at determining if lenalidomide is safe and active in patients with mantle cell lymphoma who are refractory to their treatment or have relapsed once, twice or three times. Enrollment goal was met on March 7th 2013 and thus enrollment was stopped.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Biopsy proven mantle cell lymphoma

- Patients who are refractory to their regimen or have relapsed once, twice or up to

three times and who have documented progressive disease

- Eastern Cooperative Oncology Group (ECOG) performance score 0,1, or 2

- Willing to follow pregnancy precaution

Exclusion Criteria:

- Any of the following laboratory abnormalities

- Absolute neutrophil count (ANC)<1,500 cells/mm^3 (1. 5 x 10^9/L)

- Platelet count < 60,000/mm^3 (60 x 10^9/L)

- Serum aspartate transaminase/Serum glutamic oxaloacetic transaminase(AST/SGOT) or

Alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) >3. 0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma

- Serum total bilirubin > 1. 5 x ULN, except in case of Gilbert's Syndrome and

documented liver involvement by lymphoma.

- Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min

- History of active central nervous system (CNS) lymphoma within the previous 3 months

- Subjects not willing to take Deep venous thrombosis (DVT) prophylaxis

- Known seropositive for or active viral infection with human immunodeficiency virus

(HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible

Locations and Contacts

UZ Brussels, Brussel 1090, Belgium

UZ Gent, Gent 9000, Belgium

AZ Groeninge, Kortrijk 8500, Belgium

Cliniques Universitaires UCL de Mont-Godine, Yvoir 5530, Belgium

Teaching Hospital BrnoHemato-oncology Dept, Brno 625 00, Czech Republic

University Hospital2.Dep. of Int.med. hematology, Hradec Kralove 500 05, Czech Republic

Charles University General Hospital, Prague 12808, Czech Republic

Rigshospitalet Department of Haematology L4042, Copenhagen 2100, Denmark

Herlev Hospital, Herlev 2730, Denmark

Polyclinique Bordeaux Nord Aquitaine Service Onco-Hematologie, Bordeaux 33300, France

Hôtel Dieu, Clermont Ferrand 63003, France

CHU Hopital Michallon, Grenoble cedex 09 38043, France

Centre Hospitalier Departemental Les Oudrairies, La Roche sur Yon 85025, France

Clinique Victor Hugo, Le Mans 72000, France

CHRU-Hopital Claude Huriez, Lille 59037, France

CHU Dupuytren, Limoges Cedex 1 87042, France

Centre Léon Bérard, Lyon 69373, France

Institut Paoli-Calmettes, Marseille 13273, France

CHU Montpellier - Hôpital Saint Eloi, Montpellier CEDEX 5 34295, France

CHRU - Hotel Dieu, Nantes Cedex 1 44093, France

Centre Antoine Lacassagne Oncologie médicale et Hématologie, Nice cedex 1 06050, France

Hopital Saint-Louis, Paris 75010, France

CHRU - Hôpital du Haut Lévêque, Pessac 33604, France

Centre Hospitalier Lyon Sud, Pierre-Bénite cedex 69495, France

CHU Rennes Hematology, Rennes 35033, France

Centre Henri Becquerel, Rouen Cedex 79038, France

CHRU Hôpital de Hautepierre, Strasbourg 67098, France

Hopital civil, Strasbourg 67091, France

CHRU Hopitaux de Brabois, Vandoeuvre 54511, France

Universitätsklinikum Essen, Essen 45122, Germany

Universitaetsklinikum FreiburgInnere Med.1, Haematologie, Freiburg 79106, Germany

UKG Universitätsklinikum Göttingen, Göttingen 37099, Germany

Asklepios Klinik St. Georg, Hamburg D-20099, Germany

Universitätsklinikum des Saarlandes, Homburg-Saar 66421, Germany

Städtisches Klinikum Karlsruhe, Karlsruhe 76135, Germany

Uniklinik Köln, Koeln 50937, Germany

Universitätsklinik Münster, Muenster 48129, Germany

University of Ulm, Ulm 89081, Germany

Attikon General University Hospital of Athens, Athens 12462, Greece

University of Patras, Patras 26500, Greece

Rambam Medical Center, Haifa 35254, Israel

Hadassah University Hospital, Jerusalem 91120, Israel

Rabin Medical Center, Petach-Tikva 49100, Israel

Sheba Medical Center, Tel Hashomer 52621, Israel

A.O. Policlinico - Università di Bari, Bari 70124, Italy

A.O.U. di Bologna Policlinico S.Orsola-Malpighi, Bologna 40138, Italy

Ospedale Regionale di Bolzano, Bolzano 39100, Italy

Ospedale Ferrarotto, Catania 95124, Italy

Azienda Ospedaliera Universitaria San Martino, Genova 16132, Italy

Ematologia ed Immunologia, Lecce 73100, Italy

Istituto Europeo di Oncologia - IEO, Milano 20141, Italy

San Raffaele Scientific Institute, Milano 20932, Italy

Az. Osp. Vincenzo Cervello, Palermo 90146, Italy

I.R.C.C.S. Policlinico San Matteo, Pavia 27100, Italy

Az. Osp di Perugia, Perugia 06100, Italy

Ospedale S. Chiara, Pisa 56126, Italy

Azienda Ospedaliera "Bianchi-Melacrino-Morelli", Reggio Calabria 89100, Italy

Reference Cancer Center of Basilicata, Rionero in Vulture 85028, Italy

IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo 71013, Italy

Meander Medisch Centrum, Amersfoort 3818 ES, Netherlands

Medisch Spectrum Twente, Enshede 7513, Netherlands

Isala Klinieken, Zwolle 8011, Netherlands

Uniwersytet Jagiellonski Collegium Medicum, Krakow 31-501, Poland

Malopolskie Centrum medyczne s.c., Kraków 30-510, Poland

Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Lodzi, Lodz 93-510, Poland

Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie, Warsaw 02-781, Poland

Dolnoslaskie Centrum Transplantacji Komórkowych, Wroclaw 53-439, Poland

Nowotworów Krwi i Transplantacji Szpiku, Wroclaw 50-367, Poland

Sverdlovsk Regional Clinical Hospital #1, Ekaterinburg 620102, Russian Federation

Republic Clinical Oncology Dispensary, Kazan 420029, Russian Federation

Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl, Moscow 115447, Russian Federation

Nizhegorodskiy Regional Clinical Hospital named after N.A. Semashko, Nizhniy Novgorod 603126, Russian Federation

Novosibirsk State Regional Clinical Hospital, Novosibirsk 630087, Russian Federation

Medical Radiology Research Centre RAMS, Obninsk 249036, Russian Federation

Perm Territorial Oncology Dispensary, Perm 614066, Russian Federation

Scientific Research Institute of OncologySoft Tissue Department, Rostov-na-Donu 344937, Russian Federation

St. Petersburg Pavlov State Medical University, Saint-Petersburg 196022, Russian Federation

St. Petersburg Research Institute of Hematology and Blood Transfusion, Saint-Petersburg 191024, Russian Federation

Saratov Medical University Chair of Professional Pathology and Haematology, Saratov 410 028, Russian Federation

Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov, St. Petersburg 197341, Russian Federation

Volgograd Regional Clinical Oncology Dispensary #1, Volgograd 400138, Russian Federation

Hospital Universitario Vall D`Hebron, Barcelona 8035, Spain

Hospital de La Princesa, Madrid 28006, Spain

Hospital La Paz, Madrid 28046, Spain

Hospital Costa del Sol, Marbella 29603, Spain

Clinica Universitaria de Navarra, Pamplona 31008, Spain

Lund University Hosptial, Lund 22185, Sweden

University Hospital Uppsala, Uppsala 75185, Sweden

Royal Bournemouth Hosp, Bournemouth BH7 7DW, United Kingdom

Addenbrookes Hospital, Cambridge CB2 0QQ, United Kingdom

Royal Liverpool University Hospital, Liverpool L7 8XP, United Kingdom

Christie Hospital, Manchester M20 4BX, United Kingdom

Newcastle Hospital Foundation Trust, Newcastle Upon Tyne NE1 4LP, United Kingdom

John Radcliffe Hospital, Oxford OX3 7LJ, United Kingdom

Derriford Hospital, Plymouth PL6 8DH, United Kingdom

Southampton General Hospital, Southampton SO16 6YD, United Kingdom

Royal Wolverhampton Hospital NHS Trust, Wolverhampton WV10 0QP, United Kingdom

Additional Information

Starting date: April 2009
Last updated: August 19, 2015

Page last updated: August 23, 2015

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