A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00322985|
Recruitment Status : Completed
First Posted : May 9, 2006
Last Update Posted : March 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|T-cell Lymphoma||Drug: Lenalidomide||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||July 2014|
- overall response rate [ Time Frame: every 3 months ]Defined by the Cheson criteria for response in lymphoma and will be expressed as percentages
- complete response rate [ Time Frame: every 3 months ]Defined by the Cheson criteria for response in lymphoma and will be expressed as percentages.
- Time To Progression [TTP] [ Time Frame: every 3 months ]Kaplan-Meier curves will be used to plot Time to Progression.
- survival [ Time Frame: every 3 months ]Kaplan-Meier curves will be used to plot survival.
- safety [ Time Frame: every 3 months ]The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events v3 whenever possible. The first interim safety analysis will be conducted by the Data Monitoring Committee after the first 10 patients have completed therapy on trial. This safety analysis will be repeated at the second interim analysis of 22 patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322985
|Tom Baker Cancer Centre|
|Calgary, Alberta, Canada|
|Cross Cancer Institute|
|Edmonton, Alberta, Canada, T6G 1Z2|
|Cancer Care Manitoba|
|Winnipeg, Manitoba, Canada|
|Canada, Nova Scotia|
|Queen Elizabeth II, Health Services Centre|
|Halifax,, Nova Scotia, Canada|
|Ottawa Hospital General Campus|
|Ottawa, Ontario, Canada|
|Principal Investigator:||Tony Reiman, MD||Alberta Health Services|