Clinical Trial: Fludarabine, Cyclophosphamide, and Thalidomide in Treating Patients With Angioimmunoblastic T-Cell Lymphoma

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of lymphoma by blocking blood flow to the cancer. Giving fludarabine and cyclophosphamide together with thalidomide may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving fludarabine and cyclophosphamide together with thalidomide works in treating patients with angioimmunoblastic T-cell lymphoma.


Detailed Summary:

OBJECTIVES:

Primary

  • Determine the response rate in patients with angioimmunoblastic T-cell lymphoma after chemotherapy comprising fludarabine and cyclophosphamide.

Secondary

  • Assess the incremental anatomical and molecular response rate in these patients during treatment with thalidomide.
  • Determine the toxicity of treatment with fludarabine and cyclophosphamide followed by thalidomide.
  • Assess the progression-free and overall survival of these patients.
  • Develop a detailed pathological description of the disease at presentation and at relapse.
  • Assess the number of circulating clonal T cells at presentation and during thalidomide treatment.
  • Screen for possible etiological viruses at presentation.
  • Evaluate the evolution of EBV viral load during follow-up.

OUTLINE: This is a multicenter study.

Patients receive oral or IV fludarabine and oral or IV cyclophosphamide once daily on days 1-3. Courses repeat every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity. Beginning at least 4 weeks after completion of chemotherapy, patients who achieve at least stable disease receive oral thalidomide once daily for at least 6 months.

Lymph nodes, marrow, and peripheral blood will be collected periodically for research studies.

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Sponsor: Cancer Research UK

Current Primary Outcome: Response rate after chemotherapy with fludarabine and cyclophosphamide

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incremental response rate to thalidomide treatment
  • Toxicity according to the NCI CTCAE v.3.0
  • Progression-free and overall survival


Original Secondary Outcome: Same as current

Information By: National Cancer Institute (NCI)

Dates:
Date Received: August 12, 2009
Date Started: January 2006
Date Completion:
Last Updated: August 23, 2013
Last Verified: August 2009