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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Participants Categorized by Best Response as Determined by Central Review

Outcome Description:

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.

Outcome Time Frame:

Up to 1459 days

Safety Issue:

No

Principal Investigator

Lei Zhang, MD

Investigator Role:

Study Director

Investigator Affiliation:

Celgene Corporation

Authority:

United States: Food and Drug Administration

Study ID:

CC-5013-NHL-003

NCT ID:

NCT00413036

Start Date:

June 2006

Completion Date:

May 2011

Related Keywords:

• Lymphoma, Non-Hodgkin's
• Celgene
• Revlimid
• CC-5013
• Non-hodgkin's lymphoma
• Lenalidomide
• CC5013
• NHL
• Lymphoma
• Lymphoma, Non-Hodgkin