A Phase II Study of Alemtuzumab in Combination With CHOP as First-Line Treatment in Peripheral T-Cell Lymphoma
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Surapol Issaragrisil, M.D.,Prof.
Thailand: Food and Drug Administration