A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma
- Registration Number
- NCT00413036
- Lead Sponsor
- Celgene
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description lenalidomide lenalidomide 25 mg oral lenalidomide once daily on Days 1-21 every 28 days
- Primary Outcome Measures
Name Time Method Participants Categorized by Best Response as Determined by Central Review Up to 1459 days 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.
- Secondary Outcome Measures
Name Time Method Duration of Response as Determined by Central Review Up to 1459 days Kaplan-Meier estimates for the duration of response were calculated for responders and defined as the time from at least a partial response (PR) to progression of disease (PD) or death due to Non-Hodgkin's lymphoma.
For response assessment criteria (per Cheson, 1999) see the primary outcome measure in this results posting.Time to Progression as Determined by Central Review Up to 1459 days Kaplan-Meier estimate of time-to-progression is calculated as time from the start of study drug therapy to the first observation of disease progression.
Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.
* Progressive Disease(PD): Appearance of new lesion during/end of therapy; \>=50% increase from lowest measurement in SPD.Progression-free Survival as Determined by Central Review Up to 1459 days Kaplan-Meier estimate of progression-free survival is defined as start of study drug therapy to the first observation of progressive disease or death due to any cause, whichever comes first.
Response assessed according to Cheson, Journal of Clinical Oncology, 1999. Full definition of progressive disease, refer to Cheson article.
* Progressive Disease(PD): Appearance of new lesion during/end of therapy; \>=50% increase from lowest measurement in SPD.Proportion of Participants Who Experienced Stable Disease or Better as Determined by Central Review Up to 1459 days 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.
Trial Locations
- Locations (48)
Ochsner Clinic Foundation
🇺🇸Baton Rouge, Louisiana, United States
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
Access Clinical Research
🇺🇸Rancho Mirage, California, United States
Sylvester Cancer Center/ Univeristy of Miami
🇺🇸Miami, Florida, United States
Kaiser Permanente Medical Group
🇺🇸San Diego, California, United States
HIllman Cancer Center -UPMC
🇺🇸Pittsburg, Pennsylvania, United States
Toronto Sunnybrook Regional Cancer Centre
🇨🇦Toronto, Canada
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Northwest Alabama Cancer Center, PC
🇺🇸Muscle Shoals, Alabama, United States
Lalita Pandit, MD, Inc
🇺🇸Fountain Valley, California, United States
Pasco Hernando Oncology Associates
🇺🇸Brooksville, Florida, United States
Hematology Oncology Associates of Central Brevard
🇺🇸Rockledge, Florida, 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
Our Lady of Mercy Cancer Center
🇺🇸Bronx, New York, United States
Palmetto Hematology Oncology
🇺🇸Spartanburg, South Carolina, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
London Health Science Center
🇨🇦London, Ontario, Canada
Family Cancer Center
🇺🇸Collierville, Tennessee, United States
Service d'Hématologie Clinique
🇫🇷Créteil, France
Saskatoon Cancer Center
🇨🇦Saskatoon, Saskatchewan, Canada
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
Centre Hospitalier Lyon Sud, Hematologie Clinique
🇫🇷Pierre Bénite, France
Hopital du Haut-Lévèque
🇫🇷Pessac, France
Department d'Hématologie Centre Henri Becquerel
🇫🇷Rouen, France
Research Site
🇪🇸Valencia, Spain
Institute of Hematology and Medical Oncology "L. & A. Serà gnoli"
🇮🇹Bologna, Italy
O.U. di Clinica Ematologica
🇮🇹Genova, Italy
Dipartimento di Oncologia dei Trapianti e delle Nuove Tecnologie in Medicina
🇮🇹Roma, Italy
Ospedale Policlinico S. Matteo
🇮🇹Pavia, Italy
Azienda Sanitaria Ospedaliera San Giovanni Battista (Molinette),
🇮🇹Torino, Italy
Hospital Clinic I Provincial, Servicio de Hematologia
🇪🇸Barcelona, Spain
Hospital Universitario 12 de Octubre,
🇪🇸Madrid, Spain
Hospital Universitario Virgen de la Victoria, Servicio de oncologia
🇪🇸Malaga, Spain
Clinica Universitaria de Navarra
🇪🇸Pamplona, Spain
Royal Marsden Hospital NHS Foundation Trust London and Surrey
🇬🇧Surrey, United Kingdom
Somers Cancer Research Building
🇬🇧Southampton, United Kingdom
Hospital Clinico Universitario de Salamanca, Servicio de Hematologia
🇪🇸Salamanca, Spain
Medical Oncology, Christie Hospital NHS Trust
🇬🇧Withington, United Kingdom
Cancer Care Center, Inc.
🇺🇸New Albany, Indiana, United States
Michigan Hematology and Oncology Institute
🇺🇸Southgate, Michigan, United States
Complexo Hospitalario de Pontevedra Oncology Department
🇪🇸Pontevedra, Spain
Universitaetsklinikum Essen
🇩🇪Essen, Germany
Hospital Clinicio San Carlos, Servivio de Hematologia Clinica
🇪🇸Madrid, Spain