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:
Celgene Corporation
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00875667
First received: April 1, 2009
Last updated: March 11, 2013
Last verified: March 2013
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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:
Drug Information available for:
Cytarabine
Chlorambucil
Fludarabine
Fludarabine phosphate
Gemcitabine
Gemcitabine hydrochloride
Rituximab
Lenalidomide
U.S. FDA Resources
Further study details as provided by Celgene Corporation:
Primary Outcome Measures:
- Progression free survival (PFS) [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall response rate [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Tumor control rate [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Time to treatment failure [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Time to tumor response [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
- Safety [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
- Quality of Life [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
| Enrollment: | 254 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | July 2017 |
| Estimated Primary Completion Date: | May 2014 (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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875667
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| Belgium | |
| Universitair Ziekenhuis Gent | |
| Gent, Belgium | |
| Universitair Ziekenhuis Brussel | |
| Jette, Belgium | |
| AZ Groeninghe - Campus Maria's Voorzienigheid | |
| Kortrijk, Belgium | |
| Cliniques Universitaires UCL Mont-Godinne | |
| Yvoir, Belgium | |
| Czech Republic | |
| FN Brno | |
| Brno-Bohunice, Czech Republic | |
| Fakultni nemocnice Hradec Kralove | |
| Hradec Králové, Czech Republic | |
| Charles University General Hospital | |
| Praha, Czech Republic, 12808 | |
| Denmark | |
| Rigshospitalet | |
| Copenhagen, Denmark | |
| Herlev Hospital | |
| Herlev, Denmark | |
| France | |
| Polyclinique Bordeaux Nord Aquitaine | |
| Bordeaux, France | |
| Hôpital Hôtel Dieu | |
| Clermont-Ferrand, France | |
| CHU Hôpital Michallon | |
| Grenoble, France | |
| Centre Hospitalier, Les Oudrairies | |
| La Roche sur Yon, France | |
| Clinique Victor Hugo, Centre Jean Bernard | |
| Le Mans, France | |
| CHRU- Hôpital Claude Huriez | |
| Lille, France | |
| Hôpital Universitaire Dupuytren | |
| Limoges Cedex 1, France | |
| Centre Léon Berard | |
| Lyon, France | |
| Centre Hospitalier Lyon Sud | |
| Lyon Sud, France | |
| Institute Paoli-Calmettes | |
| Marseille, France | |
| CHU Montpellier - Hôpital Lapeyronie | |
| Montpellier, France | |
| CHRU - Hotel Dieu, Hématologie | |
| Nantes Cedex 1,, France | |
| Centre Antoine Lacassagne | |
| Nice Cedex 1, France | |
| Hôptal Saint-Louis | |
| Paris, France | |
| CHRU - Hôpital du Haut Lévêque | |
| Pessac, France | |
| CHU de Rennes Hôpital de Pontchaillou | |
| Rennes Cedex, France | |
| Centre Henri Becquerel | |
| Rouen, France | |
| Hopital civil | |
| Strasbourg, France | |
| Hôpital Haute Pierre | |
| Strasbourg, France | |
| CHRU Hôpitaux de Brabois | |
| Vandoeuvre, France | |
| Germany | |
| Universitätsklinikum Essen | |
| Essen, Germany | |
| Universitätsklinikum Freiburg - Medizinische Klinik | |
| Freiburg, Germany | |
| UKG Universitätsklinikum Göttingen | |
| Göttingen, Germany | |
| Asklepios Klinik St. Georg | |
| Hamburg, Germany | |
| Universitätsklinikum des Saarlandes | |
| Homburg-Saar, Germany | |
| Städtisches Klinikum Karlsruhe | |
| Karlsruhe, Germany | |
| Klinikum der Universität zu Köln | |
| Köln, Germany | |
| Universitätsklinikum Münster | |
| Münster, Germany | |
| Universitätsklinikum Ulm | |
| Ulm, Germany | |
| Greece | |
| University of Athens | |
| Athens, Greece | |
| Attikon General University Hospital of Athens, Chaidari | |
| Athens, Greece | |
| University of Patras | |
| Patras, Greece | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel | |
| Hadassah University Hospital, | |
| Jerusalem, Israel | |
| Rabin Medical Center | |
| Petach Tiqva, Israel | |
| Sheba Medical Center | |
| Tel Hashomer, Israel | |
| Italy | |
| Policlinico di Bari | |
| Bari, Italy | |
| Azienda Ospedaliera Universitaria Policlinico Sant'Orsola | |
| Bologna, Italy | |
| Ospedale Regionale di Bolzano | |
| Bolzano, Italy | |
| Azienda Ospedale Ferrarotto | |
| Catania, Italy | |
| Az. Osp. Univ. San Martino | |
| Genova, Italy | |
| Ostedale "Vito Fazzi" Lecce | |
| Lecce, Italy | |
| Istituto Europeo di Oncologia | |
| Milano, Italy | |
| Fondazione San Raffaele del Monte Tabor | |
| Milano, Italy | |
| Az. Osp. Vincenzo Cervello | |
| Palermo, Italy | |
| Casa di Cura La Maddalena | |
| Palermo, Italy | |
| Università di Pavia, Fondazione IRCCS Policlinico San Matteo | |
| Pavia, Italy | |
| Az. Osp di Perugia | |
| Perugia, Italy | |
| Università di Pisa | |
| Pisa, Italy | |
| Az. Osp. Bianchi Melacrino Morelli | |
| Reggio Calabria, Italy | |
| CROB - Centro di Rif. Oncologico della Basilicata | |
| Rionero In Vulture, Italy | |
| IRCCS Casa Sollievo della Sofferenza | |
| San Giovanni Rotondo, Italy | |
| Netherlands | |
| Meander Medisch Centrum | |
| Amersfoort, Netherlands | |
| Medisch Spectrum Twente KA | |
| Enschede, Netherlands | |
| Isala Clinics Zwolle, AB | |
| Zwolle, Netherlands | |
| Poland | |
| ŚAM SP SK im. A. Mielęckiego | |
| Katowice, Poland | |
| Uniwersytet Jagiellonski Collegium Medicum | |
| Kraków, Poland | |
| Uniwersytet Medyczny, Katedra I Klinika Hematologii I | |
| Lublin, Poland | |
| Samodzielny Publiczny Szpital Kliniczny nr 1 | |
| Lublin, Poland | |
| Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu | |
| Poznań, Poland | |
| Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie w Warszawie | |
| Warszawa, Poland | |
| Samodzielny Publiczny Centralny Szpital Kliniczny nr 1 | |
| Warszawa, Poland | |
| Szpital Kliniczny Nr1 | |
| Wrocław, Poland | |
| Dolnośląskie Centrum Transplantacji Komórkowych | |
| Wrocław, Poland | |
| S.P. Szpital Kliniczny Nr1, Klinika Hematologii Nowotworów Krwi i Transplantacji Szpiku, ul. Pasteura | |
| Wrocław, Poland, 50-367 | |
| Wojewódzki Szpital Specjalistyczny im. M. Kopernika w Łodzi | |
| Łódź, Poland | |
| Russian Federation | |
| Republic Clinical Oncology Dispensary | |
| Kazan, Russian Federation | |
| Blokhin Cancer Research Center | |
| Moscow, Russian Federation | |
| State Healthcare Institution "Nizhegorodskiy Regional Clinical Hospital named after N.A. Semashko" | |
| Nizhny Novgorod, Russian Federation | |
| State Healthcare Institution "Perm Territorial Oncology Dispensary" | |
| Perm, Russian Federation | |
| St. Petersburg Research Institute of Hematology and Blood Transfusion | |
| St. Petersburg, Russian Federation, 193024 | |
| St. Petersburg Pavlov State Medical University Hematology Center | |
| St. Petersburg, Russian Federation | |
| Federal State Institution "Federal Centre of Heart, Blood and Endocrinology of Rosmedtechnologies named after V.A. Almazov" | |
| St. Petersburg, Russian Federation | |
| State Healthcare Institution "Volgograd Regional Clinical OncologyDispensary #1" | |
| Volgograd, Russian Federation | |
| State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1" | |
| Yekaterinburg, Russian Federation | |
| Spain | |
| H. Universitari 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 | |
| Sweden | |
| Lund University hospital | |
| Lund, Sweden | |
| Akademiska University Hospital Uppsala | |
| Uppsala, Sweden | |
| United Kingdom | |
| Addenbrookes Hospital | |
| Cambridge, United Kingdom | |
| The Royal Bournemouth Hospital | |
| Dorset,, United Kingdom | |
| Royal Liverpool University Hospital | |
| Liverpool, United Kingdom | |
| Christie Hospital | |
| Manchester, United Kingdom | |
| Newcastle Hospitals Foundation Trust, Royal Victoria Infirmary | |
| Newcastle upon Tyne, United Kingdom | |
| Oxford Radcliffe Hospital | |
| Oxford, United Kingdom | |
| Derriford Hospital | |
| Plymouth, United Kingdom | |
| Cancer Research UK Clinical Centre - Southampton General Hospital | |
| Southampton, United Kingdom | |
| Royal Wolverhampton Hospitals NHS Trust | |
| Wolverhampton, United Kingdom | |
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
No publications provided
| 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: | March 11, 2013 |
| 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 Cytarabine Fludarabine monophosphate Thalidomide Fludarabine Lenalidomide Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances |
ClinicalTrials.gov processed this record on June 17, 2013