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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate after chemotherapy with fludarabine and cyclophosphamide

Safety Issue:

No

Principal Investigator

Claudius Rudin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Devon and Exeter Hospital

Authority:

Unspecified

Study ID:

CDR0000644123

NCT ID:

NCT00958854

Start Date:

January 2006

Completion Date:

Related Keywords:

  • Lymphoma
  • angioimmunoblastic T-cell lymphoma
  • Immunoblastic Lymphadenopathy
  • Lymphoma
  • Lymphoma, T-Cell

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