A Phase II Study of Alemtuzumab in Combination With CHOP and ESHAP as First-Line Treatment in Peripheral T-Cell Lymphoma
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, doxorubicin, vincristine and prednisolone) is currently regarded as
a standard chemotherapy regimen for patients with newly diagnosed NHL.
ESHAP (etoposide, methylprednisolone, cisplatin, cytosine arabinoside) chemotherapy was
invented in 1994. The regimen was aimed to salvage NHL patients who were relapsing or
refractory to front-line, mostly doxorubicin-based, chemotherapy.Major toxicities were
myelosuppression; 30% of the patients developed febrile neutropenia and was admitted for
parenteral antibiotics. Treatment-related deaths, mostly from uncontrolled sepsis, occurred
in 4% of the patients. Because of its efficacy and tolerable toxicities, at present, ESHAP
is one of the salvage chemotherapy regimens most frequently administered to patients
especially prior to autologous stem cell transplantation.
Recently, our unit had reported the efficacy of the combination of standard CHOP
chemotherapy and ESHAP and high-dose therapy with autologous stem cell transplantation or
rituximab given as upfront therapy in patients newly diagnosed as poor prognosis aggressive
NHL (high- and high-intermediate risk groups according to the international index).15,16
According to the previous institutional experience as well as the efficacy of the
combination of CHOP and ESHAP in patients with high-risk aggressive lymphoma, we would like
therefore to determine the outcome of alemtuzumab given in combination with CHOP and ESHAP
in patients newly diagnosed with PTCL, the effectiveness of which has not been known.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The response to treatment and the treatment-related toxicity.
Tanin Intragumtornchai, M.D.
Division of Hematology and Stem Cell Transplant, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Thailand: Food and Drug Administration