Peripheral T-Cell Lymphoma Clinical Trial
Official title:
A Phase II Study of Alemtuzumab in Combination With CHOP as First-Line Treatment in Peripheral T-Cell Lymphoma
Verified date | February 2007 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Food and Drug Administration |
Study type | Interventional |
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 in patients with peripheral T-cell lymphoma.
Status | Terminated |
Enrollment | 4 |
Est. completion date | August 2009 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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). |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Siriraj Hospital, Mahidol University | Bangkoknoi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University | Bayer |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the effectiveness of alemtuzumab given in combination with CHOP in terms of the rates of objective response rate (ORR:complete remission[CR] and | |||
Primary | partial remission[PR]),progressive disease-free(PFS) and overall survivals(OS) | |||
Primary | in patients newly diagnosed with PTCL. | |||
Secondary | To determine the safety profiles of alemtuzumab given in combination with CHOP |
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