A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma
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T-cell Non-Hodgkin's lymphomas are a group of cancers that are usually treated with chemotherapy, radiation therapy, or occasionally surgery. T-cell lymphomas are relatively uncommon and therefore not well studied. Treatment approaches are patterned after the more common B-cell lymphomas. T-cell lymphomas are more likely to relapse following standard therapy than are B-cell lymphomas. New therapies are needed for T-cell lymphomas. In this study, we will administer the drug called lenalidomide as a pill to patients with T-cell lymphoma. The goals are to determine if the drug can induce regression of the cancer, and to determine if the treatment is well tolerated in this patient group. This study will take place at six cancer centres across Canada.
overall response rate [ Time Frame: every 3 months ]
Defined by the Cheson criteria for response in lymphoma and will be expressed as percentages
Secondary Outcome Measures :
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
T-cell lymphoma (excluding mycosis fungoides)
WHO performance status 0-2
acceptable hematological and biochemical parameters
previously treated OR untreated but not suitable for standard therapy