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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
No
Lei Zhang, MD
Study Director
Celgene Corporation
United States: Food and Drug Administration
CC-5013-NHL-003
NCT00413036
June 2006
May 2011
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
Mayo Clinic | Rochester, Minnesota 55905 |
Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
Kaiser Permanente Medical Group | Los Angeles, California 90027 |
Center for Cancer And Hematologic Disease | Cherry Hill, New Jersey 08046 |
Palm Beach Cancer Institute | West Palm Beach, Florida 33401 |
Family Cancer Center | Collierville, Tennessee 38017 |
Pasco Hernando Oncology Associates | New Port Richey, Florida 34652 |
University of Nebraska | Omaha, Nebraska 68198 |
Northwest Alabama Cancer Center, PC | Florence, Alabama 35630 |
Hematology Oncology Associates of Central Brevard | Rockledge, Florida 32955 |
Cancer Care Center, Inc. | New Albany, Indiana 47150 |
Lalita Pandit, MD, Inc | Fountain Valley, California 92708 |
Michigan Hematology and Oncology Institute | Southgate, Michigan 48195 |
Palmetto Hematology Oncology | Spartanburg, South Carolina 29303 |
Access Clinical Research | Rancho Mirage, California 92270 |
Sylvester Cancer Center/ Univeristy of Miami | Miami, Florida 33136 |
Our Lady of Mercy Cancer Center | Bronx, New York 10466 |
HIllman Cancer Center -UPMC | Pittsburg, Pennsylvania 15232 |