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

NCT ID: NCT00958854

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

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.

Conditions

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Lymphoma

Keywords

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angioimmunoblastic T-cell lymphoma

Study Design

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Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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cyclophosphamide

Intervention Type DRUG

fludarabine phosphate

Intervention Type DRUG

thalidomide

Intervention Type DRUG

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research UK

OTHER

Sponsor Role lead

Principal Investigators

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Claudius Rudin, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Devon and Exeter Hospital

Locations

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Cancer Research UK and University College London Cancer Trials Centre

Exeter, England, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Claudius Rudin, MD

Role: primary

Other Identifiers

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CRUK-UCL-AITL

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2005-003931-40

Identifier Type: -

Identifier Source: secondary_id

EU-20947

Identifier Type: -

Identifier Source: secondary_id

CDR0000644123

Identifier Type: -

Identifier Source: org_study_id