Clinical Trial: Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma
Brief Summary:
RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma.
PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.
Detailed Summary:
OBJECTIVES:
Primary
- Determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic T-cell lymphoma treated with cyclosporine.
Secondary
- Determine the disease-free, progression-free, and overall survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
OUTLINE: Patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6. Patients experiencing disease progression during weeks 7-36, receive an additional 36 weeks of therapy.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study within 2.5 years.
Sponsor: Eastern Cooperative Oncology Group
Current Primary Outcome: Response Rate (Complete and Partial Response) [ Time Frame: Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up. ]
Original Primary Outcome:
Current Secondary Outcome: Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 1 year. ]
Original Secondary Outcome:
Information By: Eastern Cooperative Oncology Group
Dates:
Date Received: October 3, 2003
Date Started: September 2005
Date Completion:
Last Updated: February 12, 2013
Last Verified: February 2013