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

Sponsor

Cancer Research UK (Other)

Overall Status

Unknown status

CT.gov ID

NCT00958854

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: cyclophosphamide Drug: fludarabine phosphate Drug: thalidomide Other: laboratory biomarker analysis	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

37 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2006

Anticipated Primary Completion Date :

Mar 1, 2012

Outcome Measures

Primary Outcome Measures

Response rate after chemotherapy with fludarabine and cyclophosphamide []

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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