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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00958854
• Other study ID #: CDR0000644123
• Secondary ID: CRUK-UCL-AITLEUD
• Status: Recruiting
• Phase: Phase 2
• First received: August 12, 2009
• Last updated: August 23, 2013
• Start date: January 2006

Study information

• Verified date: August 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 37
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• cyclophosphamide

• fludarabine phosphate

• thalidomide

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
United Kingdom	Cancer Research UK and University College London Cancer Trials Centre	Exeter	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate after chemotherapy with fludarabine and cyclophosphamide			No
Secondary	Incremental response rate to thalidomide treatment			No
Secondary	Toxicity according to the NCI CTCAE v.3.0			Yes
Secondary	Progression-free and overall survival			No