Pegaspargase and Methotrexate Based Regimens for Newly Diagnosed Extranodal NK/T Cell Lymphoma
Condition: Nasal Type Extranodal NK/T-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Extranodal NK/T cell lymphoma is an aggressive tumor with higher incidence in
      Asia.Traditional CHOP/CHOP-like regiment can't produce satisfied outcome for the patients.
      Asparaginase-based treatment has been demonstrated as promising response rate and survival
      superiority. Stage-specified regimen may bring out exciting efficacy with good safety.
    

Detailed description: 
      Extranodal NK/T cell lymphoma is a kind of tumor more prevalent in Asia and South America
      than that in the Western world, which is almost invariably EBV- associated and often presents
      as localized disease in and around the nasal structures. The disease frequency was higher in
      Asian countries with no differences in age, gender or immunophenotypic profile between nasal
      and extranasal cases. EBV is a constant finding, particularly in the cases presenting as
      localized nasal disease and assumed involved in the pathogenesis. During the past decades the
      disease, historically termed as "lethal midline granuloma" was very aggressive with poor
      survival. Five-year OS for extra-nasal disease is reported as 9% compared to 42% for
      localized disease.

      Although radiotherapy combined with or without anthracycline-based chemotherapy has been
      considered as the treatment for extranodal NK/T cell lymphoma in the past, numerous data
      suggest that this tumor is not very chemosensitive due to the p-glycoprotein expression,
      which may mediate the drug resistance. CHOP/CHOP-like schedules presented with low CR rates
      and frequent failures during chemotherapy. Disseminated involvement is much poorer in
      prognosis than localized disease with the latter is benefit more from radiotherapy.

      In the nearest ten years, many new agents have been used in the treatment of extranodal NK/T
      cell lymphoma, in which the most promising one is asparaginase. Asparaginase-containing
      regiment has demonstrated about 50% responses rates and 5-year overall survival of 65% in
      relapsed or refractory disease. The impressive outcome indicates its value in the newly
      diagnosed patients, especially in the disseminated cases. Pegaspargase as a new form of
      asparaginase displays equivalent bioactivity as L- asparaginase with longer half-time and
      lower incidence of allergy. Its clinical efficacy has been verified in the patients with
      acute lymphocytic leukemia.

      The purpose of this study is to evaluate the efficacy and safety of pegaspargase and
      methotrexate based regimens with or without radiotherapy in the newly diagnosed patients with
      extranodal NK/T cell lymphoma, including localized and disseminated cases.
    

Intervention name(s): Pegaspargase; Methotrexate; Dexamethasone; Etoposide; radiotherapy
Intervention type(s): Drug; Drug; Drug; Drug; Radiation
Intervention MeSH terms: Dexamethasone; Methotrexate; Etoposide; Pegaspargase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pegaspargase,methotrexate