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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Celgene Corporation
Alberta Cancer Foundation
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT00322985
First received: May 5, 2006
Last updated: January 28, 2014
Last verified: January 2014
  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 AHS Cancer Control Alberta:

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 2014
Estimated Primary Completion Date: September 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322985

Locations
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
Cancer Care Manitoba
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Queen Elizabeth II, Health Services Centre
Halifax,, Nova Scotia, Canada
Canada, Ontario
Ottawa Hospital General Campus
Ottawa, Ontario, Canada
Sponsors and Collaborators
AHS Cancer Control Alberta
Celgene Corporation
Alberta Cancer Foundation
Investigators
Principal Investigator: Tony Reiman, MD AHS Cancer Control Alberta
  More Information

No publications provided

Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT00322985     History of Changes
Other Study ID Numbers: 22409
Study First Received: May 5, 2006
Last Updated: January 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by AHS Cancer Control Alberta:
T-cell lymphoma
lenalidomide

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, T-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on October 19, 2014