A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
NCT ID: NCT00875667
Last Updated: 2019-09-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
254 participants
INTERVENTIONAL
2009-04-30
2018-10-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lenalidomide
Lenalidomide
Lenalidomide
For patients with a creatinine clearance of ≥ 60 mL/min: 25 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.
For patients who have a moderate renal insufficiency (creatinine clearance is ≥ 30 mL/min but \< 60mL/min: 10 mg daily x 21 days of a 28 day cycle (Cycles 1 and 2). After Cycle 2, if the patient remains free of Grade 3 or Grade 4 toxicity, the dose will be increased to 15 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.
Investigators choice single agent
Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, Fludarabine
Investigators choice single agent
Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine
Interventions
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Lenalidomide
For patients with a creatinine clearance of ≥ 60 mL/min: 25 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.
For patients who have a moderate renal insufficiency (creatinine clearance is ≥ 30 mL/min but \< 60mL/min: 10 mg daily x 21 days of a 28 day cycle (Cycles 1 and 2). After Cycle 2, if the patient remains free of Grade 3 or Grade 4 toxicity, the dose will be increased to 15 mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.
Investigators choice single agent
Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Marek Trneny, MD/PhD/Prof
Role: PRINCIPAL_INVESTIGATOR
Head, Ist Dept Medicine, Charles University Hospital; Director, Institute of Hematology and Blood Transfusion; Chair, Czech Lymphoma Study Group
Locations
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UZ Brussels
Brussels, , Belgium
UZ Gent
Ghent, , Belgium
AZ Groeninge
Kortrijk, , Belgium
Cliniques Universitaires UCL de Mont-Godine
Yvoir, , Belgium
Teaching Hospital BrnoHemato-oncology Dept
Brno, , Czechia
University Hospital2.Dep. of Int.med. hematology
Hradec Králové, , Czechia
Charles University General Hospital
Prague, , Czechia
Rigshospitalet Department of Haematology L4042
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Polyclinique Bordeaux Nord Aquitaine Service Onco-Hematologie
Bordeaux, , France
Hotel Dieu
Clermont-Ferrand, , France
CHU Hopital Michallon
Grenoble, , France
Centre Hospitalier Departemental Les Oudrairies
La Roche-sur-Yon, , France
Clinique Victor Hugo
Le Mans, , France
CHRU-Hopital Claude Huriez
Lille, , France
CHU Dupuytren
Limoges, , France
Centre Leon Berard
Lyon, , France
Institut Paoli-Calmettes
Marseille, , France
CHU Montpellier - Hôpital Saint Eloi
Montpellier, , France
CHRU - Hotel Dieu
Nantes, , France
Centre Antoine Lacassagne Oncologie medicale et Hematologie
Nice, , France
Hopital Saint-Louis
Paris, , France
CHRU - Hopital du Haut Leveque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU Rennes Hematology
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Hopital civil
Strasbourg, , France
CHRU Hôpital de Hautepierre
Strasbourg, , France
CHRU Hopitaux de Brabois
Vandœuvre-lès-Nancy, , France
Uniklinik Koln
Cologne, , Germany
Universitatsklinikum Essen
Essen, , Germany
Universitaetsklinikum FreiburgInnere Med.1, Haematologie
Freiburg im Breisgau, , Germany
UKG Universitatsklinikum Gottingen
Göttingen, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Universitatsklinikum des Saarlandes
Homburg-Saar, , Germany
Stadtisches Klinikum Karlsruhe
Karlsruhe, , Germany
Universitatsklinik Munster
Münster, , Germany
University of Ulm
Ulm, , Germany
Attikon General University Hospital of Athens
Athens, , Greece
University of Patras
Pátrai, , Greece
Rambam Medical Center
Haifa, , Israel
Hadassah University Hospital
Jerusalem, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Tel Litwinsky, , Israel
A.O. Policlinico - Università di Bari
Bari, , Italy
A.O.U. di Bologna Policlinico S.Orsola-Malpighi
Bologna, , Italy
Ospedale Regionale di Bolzano
Bolzano, , Italy
Ospedale Ferrarotto
Catania, , Italy
Azienda Ospedaliera Universitaria San Martino
Genova, , Italy
Ematologia ed Immunologia
Lecce, , Italy
Istituto Europeo di Oncologia - IEO
Milan, , Italy
San Raffaele Scientific Institute
Milan, , Italy
Az. Osp. Vincenzo Cervello
Palermo, , Italy
I.R.C.C.S. Policlinico San Matteo
Pavia, , Italy
Az. Osp di Perugia
Perugia, , Italy
Ospedale S. Chiara
Pisa, , Italy
Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
Reggio Calabria, , Italy
Reference Cancer Center of Basilicata
Rionero in Vulture, , Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, , Italy
Meander Medisch Centrum
Amersfoort, , Netherlands
Medisch Spectrum Twente
Enshede, , Netherlands
Isala Klinieken
Zwolle, , Netherlands
Malopolskie Centrum medyczne s.c.
Krakow, , Poland
Uniwersytet Jagiellonski Collegium Medicum
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, , Poland
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie
Warsaw, , Poland
Nowotworww Krwi i Transplantacji Szpiku
Wroclaw, , Poland
Dolnoslaskie Centrum Transplantacji Komorkowych
Wroclaw, , Poland
Republic Clinical Oncology Dispensary
Kazan', , Russia
Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl
Moscow, , Russia
Nizhegorodskiy Regional Clinical Hospital named after N.A. Semashko
Nizhny Novgorod, , Russia
Novosibirsk State Regional Clinical Hospital
Novosibirsk, , Russia
Medical Radiology Research Centre RAMS
Obninsk, , Russia
Perm Territorial Oncology Dispensary
Perm, , Russia
Scientific Research Institute of OncologySoft Tissue Department
Rostov-on-Don, , Russia
St. Petersburg Research Institute of Hematology and Blood Transfusion
Saint Petersburg, , Russia
St. Petersburg Pavlov State Medical University
Saint Petersburg, , Russia
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
Saint Petersburg, , Russia
Saratov Medical University Chair of Professional Pathology and Haematology
Saratov, , Russia
Volgograd Regional Clinical Oncology Dispensary 1
Volgograd, , Russia
Sverdlovsk Regional Clinical Hospital 1
Yekaterinburg, , Russia
Hospital Universitario Vall D Hebron
Barcelona, , Spain
Hospital de La Princesa
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Costa del Sol
Marbella, , Spain
Clinica Universitaria de Navarra
Pamplona, , Spain
Lund University Hosptial
Lund, , Sweden
University Hospital Uppsala
Uppsala, , Sweden
Royal Bournemouth Hosp
Bournemouth, , United Kingdom
Addenbrookes Hospital
Cambridge, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Newcastle Hospital Foundation Trust
Newcastle upon Tyne, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Southampton General Hospital
Southampton, , United Kingdom
The Royal Wolverhampton Hospital NHS Trust
Wolverhampton, , United Kingdom
Countries
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References
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Trneny M, Lamy T, Walewski J, Belada D, Mayer J, Radford J, Jurczak W, Morschhauser F, Alexeeva J, Rule S, Afanasyev B, Kaplanov K, Thyss A, Kuzmin A, Voloshin S, Kuliczkowski K, Giza A, Milpied N, Stelitano C, Marks R, Trumper L, Biyukov T, Patturajan M, Bravo MC, Arcaini L; SPRINT trial investigators and in collaboration with the European Mantle Cell Lymphoma Network. Lenalidomide versus investigator's choice in relapsed or refractory mantle cell lymphoma (MCL-002; SPRINT): a phase 2, randomised, multicentre trial. Lancet Oncol. 2016 Mar;17(3):319-331. doi: 10.1016/S1470-2045(15)00559-8. Epub 2016 Feb 16.
Hagner PR, Chiu H, Ortiz M, Apollonio B, Wang M, Couto S, Waldman MF, Flynt E, Ramsay AG, Trotter M, Gandhi AK, Chopra R, Thakurta A. Activity of lenalidomide in mantle cell lymphoma can be explained by NK cell-mediated cytotoxicity. Br J Haematol. 2017 Nov;179(3):399-409. doi: 10.1111/bjh.14866. Epub 2017 Aug 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: CC-5013-MCL-002_SAP_Final_Redacted.19 December 2012
Document Type: Statistical Analysis Plan: CC05013-MCL-002_SAP_2011_Redacted 18 July 2011
Document Type: Statistical Analysis Plan: CC-5013-MCL-002_SAP_2010_Redacted 26 July 2010
Other Identifiers
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CC-5013-MCL-002
Identifier Type: -
Identifier Source: org_study_id
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