A Study of Revlimid in the Treatment of Non-Hodgkin's Lymphoma

Phase 2

Completed

• Conditions: Lymphoma, Non-Hodgkin's
• Interventions: Drug: lenalidomide

• 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

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2006-12-18
• Study First Submitted QC: 2006-12-18
• Study First Posted: 2006-12-19
• Primary Completion: 2011-04
• Study Completion: 2011-05
• Results First Submitted: 2013-01-09
• Results First Submitted QC: 2013-03-06
• Results First Posted: 2013-04-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-17
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

Inclusion Criteria

Not provided

Exclusion Criteria

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)

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

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