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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00958854
Recruitment Status : Unknown
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
First Posted : August 13, 2009
Last Update Posted : August 26, 2013
Information provided by:
National Cancer Institute (NCI)

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:



  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2006
Estimated Primary Completion Date : March 2012

Primary Outcome Measures :
  1. Response rate after chemotherapy with fludarabine and cyclophosphamide

Secondary Outcome Measures :
  1. Incremental response rate to thalidomide treatment
  2. Toxicity according to the NCI CTCAE v.3.0
  3. Progression-free and overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Newly diagnosed angioimmunoblastic T-cell lymphoma
  • Measurable disease (i.e., anatomically assessable)


  • 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


  • No prior chemotherapy for angioimmunoblastic T-cell lymphoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00958854

United Kingdom
Cancer Research UK and University College London Cancer Trials Centre Recruiting
Exeter, England, United Kingdom, EX2 5DW
Contact: Claudius Rudin, MD    44-1392-402-850      
Sponsors and Collaborators
Cancer Research UK
Principal Investigator: Claudius Rudin, MD Royal Devon and Exeter Hospital Identifier: NCT00958854     History of Changes
Other Study ID Numbers: CDR0000644123
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: August 26, 2013
Last Verified: August 2009

Keywords provided by National Cancer Institute (NCI):
angioimmunoblastic T-cell lymphoma

Additional relevant MeSH terms:
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Leprostatic Agents
Anti-Bacterial Agents
Angiogenesis Inhibitors