A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00322985
• Date of registration: 05/05/2006
• Primary sponsor: Alberta Health Services
• Public title: A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma
• Scientific title: A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma
• Date of first enrolment: June 2006
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00322985
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Tony Reiman, MD

• Name: Tony Reiman, MD
• Affiliation: Alberta Health Services

Key inclusion & exclusion criteria

Inclusion Criteria:

- T-cell lymphoma (excluding mycosis fungoides)

- WHO performance status 0-2

- measurable lesions

- acceptable hematological and biochemical parameters

- previously treated OR untreated but not suitable for standard therapy

Exclusion Criteria:

- pregnant

- HIV

- viral hepatitis



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

T-cell Lymphoma

Intervention(s)

Drug: Lenalidomide

Primary Outcome(s)

overall response rate [Time Frame: every 3 months]

Secondary Outcome(s)

complete response rate [Time Frame: every 3 months]

safety [Time Frame: every 3 months]

survival [Time Frame: every 3 months]

Time To Progression [TTP] [Time Frame: every 3 months]

Secondary ID(s)

22409

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Alberta Cancer Foundation

Celgene Corporation