The Effectiveness of Alemtuzumab Combination With CHOP to Treat Patients Newly Diagnosed With PTCL
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Alemtuzumab in Combination With CHOP as First-Line Treatment in Peripheral T-Cell Lymphoma|
- 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
- partial remission[PR]),progressive disease-free(PFS) and overall survivals(OS)
- in patients newly diagnosed with PTCL.
- To determine the safety profiles of alemtuzumab given in combination with CHOP
|Study Start Date:||September 2006|
|Estimated Study Completion Date:||August 2009|
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 lymphomas (NHL).
CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) is currently regarded as a standard chemotherapy regimen for patients with newly diagnosed NHL.
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.Malignant T cells express particularly high numbers of CD52 cell surface markers (approximately 500,000 molecules/lymphocytes),T-cell malignancies may thus be particularly responsive to alemtuzumab.
As the response rate tend to be higher in patients newly diagnosed with PTCL, this study evaluates the efficacy of alemtuzumab in combination with CHOP administered as up-front therapy in patients newly diagnosed with PTCL in terms of response rate and overall survival.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00441025
|Siriraj Hospital, Mahidol University|
|Bangkoknoi, Bangkok, Thailand, 10700|
|Principal Investigator:||Surapol Issaragrisil, M.D.,Prof.||Siriraj Hospital|