SGN-35 in the treatment of Anaplastic Large Cell Lymphoma

• Research type

  Research Study

• Full title

  A phase II study of SGN-35 in treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL)

• IRAS ID

  14027

• Sponsor organisation

  Seattle Genetics Inc.

• Eudract number

  2008-006035-12

• Research summary

  Anaplastic Large Cell Lymphoma (ALCL) is a cancer of the lymphatic system. Lymphomas are divided into two large groups: Hodgkin Lymphomas and non-Hodgkin Lymphomas. ALCL is classified as a Non-Hodgkin lymphoma and it is characterized because the cancer cells are mainly T cells and Null cells. ALCL is a rare disease and accounts for 2% to 5% of all cases of adult Non-Hodgkin lymphomas. ALCL is characterized by the presence of large lymphoid cells expressing a protein called CD30.SGN-35 is an antibody drug conjugate (ADC) directed against the CD30 antigen and is being developed to treat patients with CD30-positive haematologic malignancies. The antibody part of SGN-35 sticks to the CD30, whilst the drug component contains a chemotherapeutic agent (MMAE) leading to cell death.Patients with ALCL who have relapsed, front-line chemotherapeutic treatment, or who did not respond to initial treatment have few treatment options available.The purpose of this study is to determine if SGN-35 is a safe and effective treatment for ALCL.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  09/H1008/76

• Date of REC Opinion

  1 Jun 2009

• REC opinion

  Further Information Favourable Opinion