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A Phase II Clinical Trial of Lenalidomide for T-Cell Non-Hodgkin's Lymphoma
This study is currently recruiting participants.
Verified by Alberta Cancer Board, March 2008
Sponsors and Collaborators: Alberta Cancer Board
Celgene Corporation
Alberta Cancer Foundation
Information provided by: Alberta Cancer Board
ClinicalTrials.gov Identifier: NCT00322985
  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 II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Lenalidomide CC 5013
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Clinical Trial of Lenalidomide for T-Cell Non-Hodgkin's Lymphoma

Further study details as provided by Alberta Cancer Board:

Primary Outcome Measures:
  • overall response rate

Secondary Outcome Measures:
  • complete response rate
  • TTP
  • survival
  • safety

Estimated Enrollment: 40
Study Start Date: June 2006
Estimated Study Completion Date: November 2006
  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 780-732-8513 tonyreim@cancerboard.ab.ca

Locations
Canada, Alberta
Cross Cancer Institute Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Paula Langenhoff, BHA     780-432-8909     paulalan@cancerboard.ab.ca    
Principal Investigator: Tony Reiman, MD            
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Clinical Research Unit     780-989-8152     clinical_trials_cci@cancerboard.ab.ca    
Sponsors and Collaborators
Alberta Cancer Board
Celgene Corporation
Alberta Cancer Foundation
Investigators
Principal Investigator: Tony Reiman, MD Alberta Cancer Board
  More Information

Study ID Numbers: HE-10-0090
Study First Received: May 5, 2006
Last Updated: September 22, 2008
ClinicalTrials.gov Identifier: NCT00322985  
Health Authority: Canada: Health Canada

Keywords provided by Alberta Cancer Board:
T-cell lymphoma
lenalidomide

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, T-Cell
Lenalidomide
Lymphoma, small cleaved-cell, diffuse
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009