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

Study Overview
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Brief Summary
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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 Description
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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. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months thereafter.

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

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: cyclophosphamide
* Drug: fludarabine phosphate
* Drug: thalidomide
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Newly diagnosed angioimmunoblastic T-cell lymphoma Measurable disease (i.e., anatomically assessable) PATIENT CHARACTERISTICS: WHO/ECOG performance status 0-2 Serum creatinine ≤ 2.5 times upper limit of normal (ULN) Bilirubin ≤ 2.5 times ULN Alkaline phosphatase ≤ 2.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception before, during, and after study treatment No known seropositivity for hepatitis B virus, hepatitis C virus, or HIV No active second malignancy or other concomitant serious medical condition, in particular peripheral neuropathy PRIOR CONCURRENT THERAPY: No prior chemotherapy for angioimmunoblastic T-cell lymphoma

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclophosphamide|nan|
|Drug: fludarabine phosphate|nan|
|Drug: thalidomide|nan|
|Other: laboratory biomarker analysis|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate after chemotherapy with fludarabine and cyclophosphamide |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental response rate to thalidomide treatment |  |  | 
| Toxicity according to the NCI CTCAE v.3.0 |  |  | 
| Progression-free and overall survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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angioimmunoblastic T-cell lymphoma