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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
217
once daily oral capsule
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.
Time frame: Up to 1459 days
Duration of Response as Determined by Central Review
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 frame: Up to 1459 days
Time to Progression as Determined by Central Review
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.
Time frame: Up to 1459 days
Progression-free Survival as Determined by Central Review
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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
...and 43 more locations
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.
Time frame: Up to 1459 days
Proportion of Participants Who Experienced Stable Disease or Better 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.
Time frame: Up to 1459 days