A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
NCT ID: NCT00413036
Last Updated: 2017-03-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
217 participants
INTERVENTIONAL
2006-06-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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lenalidomide
25 mg oral lenalidomide once daily on Days 1-21 every 28 days
lenalidomide
once daily oral capsule
Interventions
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lenalidomide
once daily oral capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Follicular center lymphoma Grade 3.
* Diffuse large B-cell lymphoma.
* Mantle cell lymphoma.
* Transformed lymphoma.
* Relapsed or refractory to previous therapy for lymphoma
* At least one prior combination chemotherapy regime
* Measurable disease on cross sectional imaging that is at least 2 cm in the longest diameter
* Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1 or 2
* Willing to follow the pregnancy precautions
Exclusion Criteria
* Absolute neutrophil count (ANC) \< 1,500 cells/mm\^3 (1.5\*10\^9/L).
* Platelet count \< 60,000/mm\^3 (60\*10\^9/L).
* Calculated creatinine clearance of \<50mL/min
* Serum glutamic oxaloacetic transaminase/aspartate aminotransferase (SGOT/AST) or Serum glutamic pyruvic transaminase/Alanine transaminase (SGPT/ALT) 5.0 times upper limit of normal (ULN).
* Serum total bilirubin \> 2.0 mg/dL (34 µmol/L)/conjugated bilirubin \>0.8mg/dL.
* Subjects who are candidates for and willing to undergo an autologous stem cell transplant.
* History of active Central Nervous System (CNS) lymphoma within the previous 6 months
* History of other malignancies within the past year
* Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Lei Zhang, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Lalita Pandit, MD, Inc
Fountain Valley, California, United States
Access Clinical Research
Rancho Mirage, California, United States
Kaiser Permanente Medical Group
San Diego, California, United States
Pasco Hernando Oncology Associates
Brooksville, Florida, United States
Sylvester Cancer Center/ Univeristy of Miami
Miami, Florida, United States
Hematology Oncology Associates of Central Brevard
Rockledge, Florida, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, United States
Cancer Care Center, Inc.
New Albany, Indiana, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, United States
Michigan Hematology and Oncology Institute
Southgate, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska
Omaha, Nebraska, United States
Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Our Lady of Mercy Cancer Center
The Bronx, New York, United States
HIllman Cancer Center -UPMC
Pittsburgh, Pennsylvania, United States
Palmetto Hematology Oncology
Spartanburg, South Carolina, United States
Family Cancer Center
Collierville, Tennessee, United States
London Health Science Center
London, Ontario, Canada
Saskatoon Cancer Center
Saskatoon, Saskatchewan, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, , Canada
Service d'Hématologie Clinique
Créteil, , France
Clinical Haematology Department
Dijon, , France
Institute Paoli-Calmettes Départmentd 'Hématologie
Marseille, , France
CHU Hopital Lapeyronie, Hematologie et Oncologie Medicale
Montpellier, , France
Hopital Saint Louis Service d'Hémato-Oncologie
Paris, , France
Hopital du Haut-Lévèque
Pessac, , France
Centre Hospitalier Lyon Sud, Hematologie Clinique
Pierre-Bénite, , France
Department d'Hématologie Centre Henri Becquerel
Rouen, , France
Research Site
Berlin, , Germany
Research Site
Cologne, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Research Site
Göttingen, , Germany
Research Site
Heidelberg, , Germany
Research Site
Homburg, , Germany
Institute of Hematology and Medical Oncology "L. & A. Seràgnoli"
Bologna, , Italy
O.U. di Clinica Ematologica
Genova, , Italy
Ospedale Policlinico S. Matteo
Pavia, , Italy
Dipartimento di Oncologia dei Trapianti e delle Nuove Tecnologie in Medicina
Roma, , Italy
Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette),
Torino, , Italy
Hospital Clinic I Provincial, Servicio de Hematologia
Barcelona, , Spain
Hospital Clinicio San Carlos, Servivio de Hematologia Clinica
Madrid, , Spain
Hospital Universitario 12 de Octubre,
Madrid, , Spain
Hospital Universitario Virgen de la Victoria, Servicio de oncologia
Málaga, , Spain
Clinica Universitaria de Navarra
Pamplona, , Spain
Complexo Hospitalario de Pontevedra Oncology Department
Pontevedra, , Spain
Hospital Clinico Universitario de Salamanca, Servicio de Hematologia
Salamanca, , Spain
Research Site
Valencia, , Spain
Somers Cancer Research Building
Southampton, , United Kingdom
Royal Marsden Hospital NHS Foundation Trust London and Surrey
Surrey, , United Kingdom
Medical Oncology, Christie Hospital NHS Trust
Withington, , United Kingdom
Countries
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References
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Zinzani PL, Vose JM, Czuczman MS, Reeder CB, Haioun C, Polikoff J, Tilly H, Zhang L, Prandi K, Li J, Witzig TE. Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: subset analysis of the NHL-003 study. Ann Oncol. 2013 Nov;24(11):2892-7. doi: 10.1093/annonc/mdt366. Epub 2013 Sep 12.
Witzig TE, Vose JM, Zinzani PL, Reeder CB, Buckstein R, Polikoff JA, Bouabdallah R, Haioun C, Tilly H, Guo P, Pietronigro D, Ervin-Haynes AL, Czuczman MS. An international phase II trial of single-agent lenalidomide for relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma. Ann Oncol. 2011 Jul;22(7):1622-1627. doi: 10.1093/annonc/mdq626. Epub 2011 Jan 12.
Other Identifiers
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CC-5013-NHL-003
Identifier Type: -
Identifier Source: org_study_id
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