Fludarabine, Cyclophosphamide, and Thalidomide in Treating Patients With Angioimmunoblastic T-Cell Lymphoma
Recruitment status was: Recruiting
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.
Drug: fludarabine phosphate
Other: laboratory biomarker analysis
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma|
- Response rate after chemotherapy with fludarabine and cyclophosphamide
- Incremental response rate to thalidomide treatment
- Toxicity according to the NCI CTCAE v.3.0
- Progression-free and overall survival
|Study Start Date:||January 2006|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
- Determine the response rate in patients with angioimmunoblastic T-cell lymphoma after chemotherapy comprising fludarabine and cyclophosphamide.
- 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.
After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958854
|Cancer Research UK and University College London Cancer Trials Centre|
|Exeter, England, United Kingdom, EX2 5DW|
|Principal Investigator:||Claudius Rudin, MD||Royal Devon and Exeter Hospital|