A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified March 2012 by Alberta Health Services
Sponsor:
Alberta Health Services
Collaborators:
Celgene Corporation
Alberta Cancer Foundation
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT00322985
First received: May 5, 2006
Last updated: March 27, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
T-cell Lymphoma |
Drug: Lenalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkin's Lymphoma |
Resource links provided by NLM:
Further study details as provided by Alberta Health Services:
Primary Outcome Measures:
- overall response rate [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Defined by the Cheson criteria for response in lymphoma and will be expressed as percentages.
- Time To Progression [TTP] [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]Kaplan-Meier curves will be used to plot Time to Progression.
- survival [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]Kaplan-Meier curves will be used to plot survival.
- safety [ Time Frame: every 3 months ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 40 |
| Study Start Date: | June 2006 |
| Estimated Study Completion Date: | September 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: Lenalidomide
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.
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322985
Contacts
| Contact: Tony Reiman, MD | 506-648-6884 | Anthony.Reiman@HorizonNB.ca |
| Contact: Andrew Belch, MD | 780-432-8757 | Andrew.Belch@albertahealthservices.ca |
Locations
| Canada, Alberta | |
| Tom Baker Cancer Centre | Recruiting |
| Calgary, Alberta, Canada | |
| Cross Cancer Institute | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Angeli Prasad 780-432-8256 | |
| Principal Investigator: Tony Reiman, MD | |
| Cross Cancer Institute | Recruiting |
| Edmonton, Alberta, Canada, T6G 1Z2 | |
| Contact: Andrew Belch, MD 780-432-8757 | |
| Canada, Manitoba | |
| Cancer Care Manitoba | Recruiting |
| Winnipeg, Manitoba, Canada | |
| Canada, Nova Scotia | |
| Queen Elizabeth II, Health Services Centre | Recruiting |
| Halifax,, Nova Scotia, Canada | |
| Canada, Ontario | |
| Ottawa Hospital General Campus | Recruiting |
| Ottawa, Ontario, Canada | |
Sponsors and Collaborators
Alberta Health Services
Celgene Corporation
Alberta Cancer Foundation
Investigators
| Principal Investigator: | Tony Reiman, MD | Alberta Health Services |
More Information
No publications provided
| Responsible Party: | Alberta Health Services |
| ClinicalTrials.gov Identifier: | NCT00322985 History of Changes |
| Other Study ID Numbers: | 22409 |
| Study First Received: | May 5, 2006 |
| Last Updated: | March 27, 2012 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Alberta Health Services:
|
T-cell lymphoma lenalidomide |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lenalidomide Thalidomide Antineoplastic Agents |
Therapeutic Uses Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on June 18, 2013