Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)
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ClinicalTrials.gov Identifier: NCT00179660 |
Recruitment Status
:
Completed
First Posted
: September 16, 2005
Results First Posted
: September 2, 2013
Last Update Posted
: January 21, 2016
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Tracking Information | |||
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First Submitted Date ICMJE | September 13, 2005 | ||
First Posted Date ICMJE | September 16, 2005 | ||
Results First Submitted Date | June 25, 2013 | ||
Results First Posted Date | September 2, 2013 | ||
Last Update Posted Date | January 21, 2016 | ||
Study Start Date ICMJE | August 2005 | ||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Percentage of Participants With Response [ Time Frame: From enrollment through study completion. Median duration on study was 3.7 months, with a maximum of 32.5 months. ] Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities. Cru: Criteria for CR above but with 1 or more of the following:
PR: 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD. |
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Original Primary Outcome Measures ICMJE |
To determine the activity of lenalidiomide in relapsed or refractory aggressive non-Hodgkin’s lymphoma. Activity will be assessed by measuring the response rate, tumor control rate, duration of response and progression free survival. | ||
Change History | Complete list of historical versions of study NCT00179660 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
To evaluate the safety of lenalidomide monotherapy as treatment for subjects with relapsed or refractory aggressive NHL. | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Safety And Efficacy Of Lenalidomide In Patients With Relapsed Or Refractory Aggressive Non-Hodgkin's Lymphoma (NHL) | ||
Official Title ICMJE | 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 | ||
Brief Summary | To determine the activity of lenalidomide in relapsed or refractory aggressive NHL. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Non-Hodgkins Lymphoma | ||
Intervention ICMJE | Drug: Lenalidomide
Capsules for oral administration.
Other Names:
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Study Arms | Experimental: Lenalidomide
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
Intervention: Drug: Lenalidomide |
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Publications * | Wiernik PH, Lossos IS, Tuscano JM, Justice G, Vose JM, Cole CE, Lam W, McBride K, Wride K, Pietronigro D, Takeshita K, Ervin-Haynes A, Zeldis JB, Habermann TM. Lenalidomide monotherapy in relapsed or refractory aggressive non-Hodgkin's lymphoma. J Clin Oncol. 2008 Oct 20;26(30):4952-7. doi: 10.1200/JCO.2007.15.3429. Epub 2008 Jul 7. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
50 | ||
Original Enrollment ICMJE |
40 | ||
Actual Study Completion Date | June 2008 | ||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||
Accepts Healthy Volunteers | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00179660 | ||
Other Study ID Numbers ICMJE | CC-5013-NHL-002 | ||
Has Data Monitoring Committee | Not Provided | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Celgene ( Celgene Corporation ) | ||
Study Sponsor ICMJE | Celgene Corporation | ||
Collaborators ICMJE | Prologue Research International | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Celgene | ||
Verification Date | December 2015 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |