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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00875667
First received: April 1, 2009
Last updated: April 22, 2016
Last verified: April 2016
  Purpose
To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory Mantle Cell Lymphoma.

Condition Intervention Phase
Mantle Cell Lymphoma
Lymphoma, Mantle-Cell
Drug: Lenalidomide
Drug: Investigators choice single agent
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: Every 90 days; Up to 95 months ] [ Designated as safety issue: No ]
    The time from randomization to the first observation of disease progression or death due to any cause.


Secondary Outcome Measures:
  • Overall response rate [ Time Frame: Every 90 days; Up to 95 months ] [ Designated as safety issue: No ]
    Rates for complete response (CR), complete response unconfirmed (CRu) and partial response (PR)

  • Duration of response [ Time Frame: Every 90 days; Up to 95 months ] [ Designated as safety issue: No ]
    The time from initial response until disease progression or death

  • Tumor control rate [ Time Frame: Every 90 days; Up to 95 months ] [ Designated as safety issue: No ]
    Rates for CR, CRu, PR and stable disease (SD)

  • Time to progression [ Time Frame: Every 90 days; Up to 95 months ] [ Designated as safety issue: No ]
    Time from randomization until objective tumor progression

  • Time to treatment failure [ Time Frame: Every 90 days; Up to 95 months ] [ Designated as safety issue: No ]
    From the first dose of study drug to discontinuation of treatment

  • Time to tumor response [ Time Frame: Every 90 days; Up to 95 months ] [ Designated as safety issue: No ]
    Time from randomization until CR, CRu or PR

  • Overall survival [ Time Frame: Every 90 days; Up to 95 months ] [ Designated as safety issue: No ]
    Time from randomization until death from any cause

  • Safety [ Time Frame: Up to 95 months ] [ Designated as safety issue: Yes ]
    An Adverse Event is any noxious, unintended, or untoward medical occurrence occurring at any dose that may appear or worsen in a patient during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the patient's health, including laboratory test values, regardless of etiology; a Serious AE is any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity (a substantial disruption of the patient's ability to conduct normal life functions), is a congenital anomaly/birth defect, constitutes an important medical event.

  • Quality of Life [ Time Frame: Baseline, Cycles 2, 4, 6, 8 and treatment discontinuation; Up to 95 months ] [ Designated as safety issue: No ]
    The EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire) is a 30-item scale composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / quality of life (QoL) scale, and six single items.


Enrollment: 254
Study Start Date: April 2009
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide
Lenalidomide
Drug: Lenalidomide

For patients with a creatinine clearance of ≥60 mL/min: 25mg 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: 10mg 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 15mg daily x 21 days of a 28 day cycle until disease progression or unacceptable toxicity.

Other Names:
  • Revlimid
  • Rev
  • CC-5013
Active Comparator: Investigators choice single agent
Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, Fludarabine
Drug: Investigators choice single agent
Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, or Fludarabine
Other Names:
  • Leukeran
  • Ritux
  • Rituxan
  • cytosine arabinoside
  • Ara-C
  • Cytosar-U
  • Gemzar
  • fludarabine phosphate
  • Fludara

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875667

  Hide Study Locations
Locations
Belgium
UZ Brussels
Brussel, Belgium, 1090
UZ Gent
Gent, Belgium, 9000
AZ Groeninge
Kortrijk, Belgium, 8500
Cliniques Universitaires UCL de Mont-Godine
Yvoir, Belgium, 5530
Czech Republic
Teaching Hospital BrnoHemato-oncology Dept
Brno, Czech Republic, 625 00
University Hospital2.Dep. of Int.med. hematology
Hradec Kralove, Czech Republic, 500 05
Charles University General Hospital
Prague, Czech Republic, 12808
Denmark
Rigshospitalet Department of Haematology L4042
Copenhagen, Denmark, 2100
Herlev Hospital
Herlev, Denmark, 2730
France
Polyclinique Bordeaux Nord Aquitaine Service Onco-Hematologie
Bordeaux, France, 33300
Hotel Dieu
Clermont Ferrand, France, 63003
CHU Hopital Michallon
Grenoble cedex 09, France, 38043
Centre Hospitalier Departemental Les Oudrairies
La Roche sur Yon, France, 85025
Clinique Victor Hugo
Le Mans, France, 72000
CHRU-Hopital Claude Huriez
Lille, France, 59037
CHU Dupuytren
Limoges Cedex 1, France, 87042
Centre Leon Berard
Lyon, France, 69373
Institut Paoli-Calmettes
Marseille, France, 13273
CHU Montpellier - Hôpital Saint Eloi
Montpellier CEDEX 5, France, 34295
CHRU - Hotel Dieu
Nantes Cedex 1, France, 44093
Centre Antoine Lacassagne Oncologie medicale et Hematologie
Nice cedex 1, France, 06050
Hopital Saint-Louis
Paris, France, 75010
CHRU - Hopital du Haut Leveque
Pessac, France, 33604
Centre Hospitalier Lyon Sud
Pierre-Bénite cedex, France, 69495
CHU Rennes Hematology
Rennes, France, 35033
Centre Henri Becquerel
Rouen Cedex, France, 79038
Hopital civil
Strasbourg, France, 67091
CHRU Hôpital de Hautepierre
Strasbourg, France, 67098
CHRU Hopitaux de Brabois
Vandoeuvre, France, 54511
Germany
Universitatsklinikum Essen
Essen, Germany, 45122
Universitaetsklinikum FreiburgInnere Med.1, Haematologie
Freiburg, Germany, 79106
UKG Universitatsklinikum Gottingen
Göttingen, Germany, 37099
Asklepios Klinik St. Georg
Hamburg, Germany, D-20099
Universitatsklinikum des Saarlandes
Homburg-Saar, Germany, 66421
Stadtisches Klinikum Karlsruhe
Karlsruhe, Germany, 76135
Uniklinik Koln
Koeln, Germany, 50937
Universitatsklinik Munster
Muenster, Germany, 48129
University of Ulm
Ulm, Germany, 89081
Greece
Attikon General University Hospital of Athens
Athens, Greece, 12462
University of Patras
Patras, Greece, 26500
Israel
Rambam Medical Center
Haifa, Israel, 35254
Hadassah University Hospital
Jerusalem, Israel, 91120
Rabin Medical Center
Petach-Tikva, Israel, 49100
Sheba Medical Center
Tel Hashomer, Israel, 52621
Italy
A.O. Policlinico - Università di Bari
Bari, Italy, 70124
A.O.U. di Bologna Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Ospedale Regionale di Bolzano
Bolzano, Italy, 39100
Ospedale Ferrarotto
Catania, Italy, 95124
Azienda Ospedaliera Universitaria San Martino
Genova, Italy, 16132
Ematologia ed Immunologia
Lecce, Italy, 73100
Istituto Europeo di Oncologia - IEO
Milano, Italy, 20141
San Raffaele Scientific Institute
Milano, Italy, 20932
Az. Osp. Vincenzo Cervello
Palermo, Italy, 90146
I.R.C.C.S. Policlinico San Matteo
Pavia, Italy, 27100
Az. Osp di Perugia
Perugia, Italy, 06100
Ospedale S. Chiara
Pisa, Italy, 56126
Azienda Ospedaliera "Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy, 89100
Reference Cancer Center of Basilicata
Rionero in Vulture, Italy, 85028
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy, 71013
Netherlands
Meander Medisch Centrum
Amersfoort, Netherlands, 3818 ES
Medisch Spectrum Twente
Enshede, Netherlands, 7513
Isala Klinieken
Zwolle, Netherlands, 8011
Poland
Uniwersytet Jagiellonski Collegium Medicum
Krakow, Poland, 31-501
Malopolskie Centrum medyczne s.c.
Kraków, Poland, 30-510
Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi
Lodz, Poland, 93-510
Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie w Warszawie
Warsaw, Poland, 02-781
Nowotworww Krwi i Transplantacji Szpiku
Wroclaw, Poland, 50-367
Dolnoslaskie Centrum Transplantacji Komorkowych
Wroclaw, Poland, 53-439
Russian Federation
Sverdlovsk Regional Clinical Hospital 1
Ekaterinburg, Russian Federation, 620102
Republic Clinical Oncology Dispensary
Kazan, Russian Federation, 420029
Institution of Russian Academy of Medical Sciences Russian Oncological Research Centre n.a. N. N. Bl
Moscow, Russian Federation, 115447
Nizhegorodskiy Regional Clinical Hospital named after N.A. Semashko
Nizhniy Novgorod, Russian Federation, 603126
Novosibirsk State Regional Clinical Hospital
Novosibirsk, Russian Federation, 630087
Medical Radiology Research Centre RAMS
Obninsk, Russian Federation, 249036
Perm Territorial Oncology Dispensary
Perm, Russian Federation, 614066
Scientific Research Institute of OncologySoft Tissue Department
Rostov-na-Donu, Russian Federation, 344937
St. Petersburg Research Institute of Hematology and Blood Transfusion
Saint-Petersburg, Russian Federation, 191024
St. Petersburg Pavlov State Medical University
Saint-Petersburg, Russian Federation, 196022
Saratov Medical University Chair of Professional Pathology and Haematology
Saratov, Russian Federation, 410 028
Federal Centre of Heart, Blood and Endocrinology of Rosmed technlologies V.A. Almazov
St. Petersburg, Russian Federation, 197341
Volgograd Regional Clinical Oncology Dispensary 1
Volgograd, Russian Federation, 400138
Spain
Hospital Universitario Vall D`Hebron
Barcelona, Spain, 8035
Hospital de La Princesa
Madrid, Spain, 28006
Hospital La Paz
Madrid, Spain, 28046
Hospital Costa del Sol
Marbella, Spain, 29603
Clinica Universitaria de Navarra
Pamplona, Spain, 31008
Sweden
Lund University Hosptial
Lund, Sweden, 22185
University Hospital Uppsala
Uppsala, Sweden, 75185
United Kingdom
Royal Bournemouth Hosp
Bournemouth, United Kingdom, BH7 7DW
Addenbrookes Hospital
Cambridge, United Kingdom, CB2 0QQ
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP
Christie Hospital
Manchester, United Kingdom, M20 4BX
Newcastle Hospital Foundation Trust
Newcastle Upon Tyne, United Kingdom, NE1 4LP
John Radcliffe Hospital
Oxford, United Kingdom, OX3 7LJ
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Royal Wolverhampton Hospital NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Marek Trneny, MD/PhD/Prof Head, Ist Dept Medicine, Charles University Hospital; Director, Institute of Hematology and Blood Transfusion; Chair, Czech Lymphoma Study Group
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00875667     History of Changes
Other Study ID Numbers: CC-5013-MCL-002 
Study First Received: April 1, 2009
Last Updated: April 22, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Denmark: Danish Medicines Agency
Greece: National Organization of Medicines
Sweden: Medical Products Agency
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Spanish Agency of Medicines
Belgium: Federal Agency for Medicinal Products and Health Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health of the Russian Federation
Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Celgene Corporation:
Mantle Cell Lymphoma
Relapsed Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma
Lymphoma
MCL

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Lenalidomide
Thalidomide
Fludarabine phosphate
Cytarabine
Fludarabine
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents

ClinicalTrials.gov processed this record on July 21, 2016