- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00958854
Fludarabine, Cyclophosphamide, and Thalidomide in Treating Patients With Angioimmunoblastic T-Cell Lymphoma
Phase II Trial of Fludarabine & Cyclophosphamide Followed by Thalidomide for Angioimmunoblastic Lymphoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
England
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Exeter, England, United Kingdom, EX2 5DW
- Recruiting
- Cancer Research UK and University College London Cancer Trials Centre
-
Contact:
- Claudius Rudin, MD
- Phone Number: 44-1392-402-850
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Response rate after chemotherapy with fludarabine and cyclophosphamide
|
Secondary Outcome Measures
Outcome Measure |
---|
Progression-free and overall survival
|
Incremental response rate to thalidomide treatment
|
Toxicity according to the NCI CTCAE v.3.0
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claudius Rudin, MD, Royal Devon and Exeter Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphadenopathy
- Lymphoma
- Immunoblastic Lymphadenopathy
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Cyclophosphamide
- Thalidomide
- Fludarabine
- Fludarabine phosphate
Other Study ID Numbers
- CDR0000644123
- CRUK-UCL-AITL
- EUDRACT-2005-003931-40
- EU-20947
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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