A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma
1 other identifier
interventional
40
1 country
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2006
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2006
CompletedFirst Posted
Study publicly available on registry
May 9, 2006
CompletedStudy Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMarch 16, 2016
March 1, 2016
7.9 years
May 5, 2006
March 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall response rate
Defined by the Cheson criteria for response in lymphoma and will be expressed as percentages
every 3 months
Secondary Outcomes (4)
complete response rate
every 3 months
Time To Progression [TTP]
every 3 months
survival
every 3 months
safety
every 3 months
Interventions
25 mg/day, orally for 21 days with 7 days rest (28 day cycle). Dosing will be in the morning at approximately the same time each day.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnant
- HIV
- viral hepatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AHS Cancer Control Albertalead
- Celgene Corporationcollaborator
- Alberta Cancer Foundationcollaborator
Study Sites (5)
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Queen Elizabeth II, Health Services Centre
Halifax, Nova Scotia, Canada
Ottawa Hospital General Campus
Ottawa, Ontario, Canada
Related Publications (1)
Toumishey E, Prasad A, Dueck G, Chua N, Finch D, Johnston J, van der Jagt R, Stewart D, White D, Belch A, Reiman T. Final report of a phase 2 clinical trial of lenalidomide monotherapy for patients with T-cell lymphoma. Cancer. 2015 Mar 1;121(5):716-23. doi: 10.1002/cncr.29103. Epub 2014 Oct 29.
PMID: 25355245DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tony Reiman, MD
Alberta Health services
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2006
First Posted
May 9, 2006
Study Start
June 1, 2006
Primary Completion
May 1, 2014
Study Completion
July 1, 2014
Last Updated
March 16, 2016
Record last verified: 2016-03