Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma
- 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
- Assess the progression-free and overall survival of these patients.
- Develop a detailed pathological description of the disease at presentation and at
- Assess the number of circulating clonal T cells at presentation and during thalidomide
- 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
Lymph nodes, marrow, and peripheral blood will be collected periodically for research
After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months thereafter.
Masking: Open Label, Primary Purpose: Treatment
Response rate after chemotherapy with fludarabine and cyclophosphamide
Claudius Rudin, MD
Royal Devon and Exeter Hospital