Status:
COMPLETED
The Effectiveness of Alemtuzumab Given in Combination With CHOP and ESHAP in Patients Newly Diagnosed With Peripheral T-Cell Lymphoma (PTCL)
Lead Sponsor:
King Chulalongkorn Memorial Hospital
Collaborating Sponsors:
Bayer
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
15-65 years
Phase:
PHASE2
Brief Summary
1. Primary Research Question What are the rates of complete response (CR), partial response (PR), progression free survival (PFS) and overall survival (OS) in adult patients newly diagnosed with Perip...
Detailed Description
Alemtuzumab (Campath-1H) is a humanized monoclonal antibody that targets CD52, a cell surface protein present at high density on most normal and malignant B and T lymphocytes. CHOP (cyclophosphamide,...
Eligibility Criteria
Inclusion
- Patients must have a diagnosis of one of the following histologic types according to the WHO classification:
- Angioimmunoblastic T-cell lymphoma
- Extranodal NK/T-cell lymphoma, nasal type
- Enteropathy-type T-cell lymphoma
- Hepatosplenic gamma-delta T-cell lymphoma
- Subcutaneous panniculitis-like T-cell lymphoma
- Anaplastic large-cell lymphoma, T/null cell, primary systemic type
- Peripheral T-cell lymphoma, not otherwise characterized
- All biopsy specimens including patients whose diagnosis have been made outside King Chulalongkorn Memorial Hospital will be reviewed by an expert hematopathologist at Department of Pathology, King Chulalongkorn Memorial Hospital.
- Newly diagnosed, age 15 - 65 years.
- Complete work up for baseline evaluation and measurement (Appendix B).
- Patient's free written inform consent.
Exclusion
- Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab.
- Patients who have received prior antilymphoma treatment with chemotherapy or radiotherapy.
- Patients with poor performance status (PS; ECOG criteria of 3-4)(Appendix C).
- Serologic evidence of human immunodeficiency virus exposure.
- Patients with history of impaired cardiac status or myocardial infarction.
- Patients with serum creatinine \> 1.8 mg/dl, bilirubin \> 1.5 times upper limit of normal range, SGOT or SGPT \> 3 times upper limit of normal range, unless due to tumor involvement.
- Patients with active uncontrolled infection, active non-malignant gastric or duodenal ulcer, uncontrolled diabetes mellitus or other severe medical conditions which would preclude aggressive cytotoxic chemotherapy.
- Pregnant or lactating women.
- Serious medical or psychiatric illness which prevent informed consent.
- Patients who are likely to lost to follow up (e.g., unwilling or difficult to return, cannot be contacted).
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00930605
Start Date
January 1 2005
End Date
July 1 2008
Last Update
October 6 2011
Active Locations (1)
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1
King Chulalongkorn Memorial Hospital
Bangkok, Thailand