A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
A Phase II, Multicenter, Single-Arm, Open-Label Study To Evaluate The Safety And Efficacy Of Single-Agent Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma
1 other identifier
interventional
217
7 countries
53
Brief Summary
Subjects who qualify will receive oral lenalidomide daily on days 1-21 of every 28 day cycle. Treatment will continue until disease progression, or unacceptable adverse events develop
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2006
Longer than P75 for phase_2
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 18, 2006
CompletedFirst Posted
Study publicly available on registry
December 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedResults Posted
Study results publicly available
April 11, 2013
CompletedMarch 1, 2017
January 1, 2017
4.8 years
December 18, 2006
January 9, 2013
January 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participants Categorized by Best Response as Determined by Central Review
Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definitions, refer to Cheson article. * Complete Response(CR): Complete disappearance of all detectable disease and disease-related symptoms if present before therapy; normalization of lab abnormalities assignable to NHL. If bone marrow involved before treatment, must be cleared on repeat biopsy. * Complete Response Unconfirmed(CRu): CR, with one of the following: 1)residual lymph node mass \>1.5 cm that has decreased by 75% in the sum of the product of the diameters(SPD). Individual nodes previously confluent decreased by more than 75% in the SPD compared with original mass; 2)indeterminate bone marrow. * Partial Response(PR): \>50% decrease in 6 largest nodes or nodal masses. Nodes selected according to Cheson. * Stable Disease(SD): Less than PR, but not progressive disease. * Progressive Disease(PD): Appearance of new lesion during/end of therapy; \>=50% increase from lowest measurement in SPD.
Up to 1459 days
Secondary Outcomes (4)
Duration of Response as Determined by Central Review
Up to 1459 days
Time to Progression as Determined by Central Review
Up to 1459 days
Progression-free Survival as Determined by Central Review
Up to 1459 days
Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review
Up to 1459 days
Study Arms (1)
lenalidomide
EXPERIMENTAL25 mg oral lenalidomide once daily on Days 1-21 every 28 days
Interventions
Eligibility Criteria
You may qualify if:
- Biopsy proven aggressive non-hodgkin's lymphoma
- 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
You may not qualify if:
- Any of the following laboratory abnormalities.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (53)
Northwest Alabama Cancer Center, PC
Muscle Shoals, Alabama, 35661, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Lalita Pandit, MD, Inc
Fountain Valley, California, 92708, United States
Access Clinical Research
Rancho Mirage, California, 92270, United States
Kaiser Permanente Medical Group
San Diego, California, 92120, United States
Pasco Hernando Oncology Associates
Brooksville, Florida, 34613, United States
Sylvester Cancer Center/ Univeristy of Miami
Miami, Florida, 33136, United States
Hematology Oncology Associates of Central Brevard
Rockledge, Florida, 32955, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Cancer Care Center, Inc.
New Albany, Indiana, 47150, United States
Ochsner Clinic Foundation
Baton Rouge, Louisiana, 70809, United States
Michigan Hematology and Oncology Institute
Southgate, Michigan, 48195, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Nebraska
Omaha, Nebraska, 68198, United States
Center for Cancer and Hematologic Disease
Cherry Hill, New Jersey, 08003, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Our Lady of Mercy Cancer Center
The Bronx, New York, 10466, United States
HIllman Cancer Center -UPMC
Pittsburgh, Pennsylvania, 15232, United States
Palmetto Hematology Oncology
Spartanburg, South Carolina, 29303, United States
Family Cancer Center
Collierville, Tennessee, 38017, United States
London Health Science Center
London, Ontario, Canada
Saskatoon Cancer Center
Saskatoon, Saskatchewan, Canada
Toronto Sunnybrook Regional Cancer Centre
Toronto, M4N 3M5, Canada
Service d'Hématologie Clinique
Créteil, 94010, France
Clinical Haematology Department
Dijon, 21034, France
Institute Paoli-Calmettes Départmentd 'Hématologie
Marseille, 13273, France
CHU Hopital Lapeyronie, Hematologie et Oncologie Medicale
Montpellier, 34295, France
Hopital Saint Louis Service d'Hémato-Oncologie
Paris, 75 475, France
Hopital du Haut-Lévèque
Pessac, 33604, France
Centre Hospitalier Lyon Sud, Hematologie Clinique
Pierre-Bénite, 69310, France
Department d'Hématologie Centre Henri Becquerel
Rouen, 76 038, France
Research Site
Berlin, Germany
Research Site
Cologne, Germany
Universitaetsklinikum Essen
Essen, 45122, Germany
Research Site
Göttingen, Germany
Research Site
Heidelberg, Germany
Research Site
Homburg, Germany
Institute of Hematology and Medical Oncology "L. & A. Seràgnoli"
Bologna, 40138, Italy
O.U. di Clinica Ematologica
Genova, 16132, Italy
Ospedale Policlinico S. Matteo
Pavia, 27100, Italy
Dipartimento di Oncologia dei Trapianti e delle Nuove Tecnologie in Medicina
Roma, 56127, Italy
Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette),
Torino, 10126, Italy
Hospital Clinic I Provincial, Servicio de Hematologia
Barcelona, 08036, Spain
Hospital Clinicio San Carlos, Servivio de Hematologia Clinica
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre,
Madrid, 28041, Spain
Hospital Universitario Virgen de la Victoria, Servicio de oncologia
Málaga, 29010, Spain
Clinica Universitaria de Navarra
Pamplona, 31008, Spain
Complexo Hospitalario de Pontevedra Oncology Department
Pontevedra, 36001, Spain
Hospital Clinico Universitario de Salamanca, Servicio de Hematologia
Salamanca, 37007, Spain
Research Site
Valencia, Spain
Somers Cancer Research Building
Southampton, SO16 6YD, United Kingdom
Royal Marsden Hospital NHS Foundation Trust London and Surrey
Surrey, SM2 5PT, United Kingdom
Medical Oncology, Christie Hospital NHS Trust
Withington, M20 4BX, United Kingdom
Related Publications (2)
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.
PMID: 24030098RESULTWitzig 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.
PMID: 21228334RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director, Clinical Trial Disclosure
- Organization
- Celgene
Study Officials
- STUDY DIRECTOR
Lei Zhang, MD
Celgene Corporation
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2006
First Posted
December 19, 2006
Study Start
June 1, 2006
Primary Completion
April 1, 2011
Study Completion
May 1, 2011
Last Updated
March 1, 2017
Results First Posted
April 11, 2013
Record last verified: 2017-01