The Effectiveness of Alemtuzumab Given in Combination With CHOP and ESHAP in Patients Newly Diagnosed With Peripheral T-Cell Lymphoma (PTCL)
Condition: Peripheral T-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
Study type: Interventional
Phase: Phase 2

Summary: 
      1. Primary Research Question What are the rates of complete response (CR), partial response
           (PR), progression free survival (PFS) and overall survival (OS) in adult patients newly
           diagnosed with Peripheral T-Cell Lymphoma (PTCL) who are treated with alemtuzumab given
           in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone)
           and ESHAP (etoposide, methylprednisolone, cisplatin, cytosine arabinoside) administered
           as an up-front treatment?

        2. Secondary Research Question What is the incidence of life-threatening toxicities (grade
           3 and 4, according to WHO criteria, Appendix A) in the patients?
    

Detailed description: 
      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.
    

Intervention name(s): CHOP regimen alternate with ESHAP regimen; Alemtuzumab
Intervention type(s): Drug; Drug
Intervention description(s): CHOP alternate with ESHAP is given every 21 days for a total of 6 course.; Alemtuzumab 30 mg/day is given subcutaneously on day 1-3 of cycle 1-5.
Intervention MeSH terms: Alemtuzumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment