Status:
TERMINATED
The Effectiveness of Alemtuzumab Combination With CHOP to Treat Patients Newly Diagnosed With PTCL
Lead Sponsor:
Mahidol University
Collaborating Sponsors:
Bayer
Conditions:
Peripheral T-Cell Lymphoma
Eligibility:
All Genders
15-65 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether the treatment of Alemtuzumab in combination with CHOP(cyclophosphamide,doxorubicin,vincristine and prednisolone) are effective as first line treatment...
Detailed Description
Peripheral T-cell lymphomas (PTCL) are more common in Asia than in Europe and United States (17-40% vs. 5-10%). Most studies reported a poorer prognosis for PTCL compared to B-cell non-Hodgkin's lymph...
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
- 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 HCV and HCV RNA of chronic hepatitis.
- Serologic evidence of HBV and HBV RNA of chronic hepatitis.
- 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.
- Active secondary malignancy.
- Pregnant or lactating women.
- Serious medical or psychiatric illness which prevent informed consent.
- Patients who are likely to lost to follow up (eg, unwilling or difficult to return,cannot be contacted).
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00441025
Start Date
September 1 2006
End Date
August 1 2009
Last Update
June 25 2009
Active Locations (1)
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1
Siriraj Hospital, Mahidol University
Bangkoknoi, Bangkok, Thailand, 10700