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. ]

Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of > 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.


Original Primary Outcome:

Current Secondary Outcome: Overall Survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 1 year. ]

Overall survival was defined as time from randomization to death from any cause.


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