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Sponsored by: |
Celgene Corporation |
Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00413036 |
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
Condition | Intervention | Phase |
Lymphoma, Non-Hodgkin's |
Drug: lenalidomide |
Phase II |
MedlinePlus related topics: | Lymphoma |
ChemIDplus related topics: | Lenalidomide CC 5013 |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 200 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
single arm: Experimental |
Drug: lenalidomide
once daily capsule dosing
Drug: lenalidomide
once daily capsule
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Key Inclusion criteria
Biopsy proven aggressive non-hodgkin's lymphoma
Key Exclusion criteria
Any of the following laboratory abnormalities.
Show 24 Study Locations |
Celgene Corporation |
Responsible Party: | Celgene Corporation ( Celgene Corporation ) |
Study ID Numbers: | CC-5013-NHL-003 |
First Received: | December 18, 2006 |
Last Updated: | April 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00413036 |
Health Authority: | United States: Food and Drug Administration |
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