Ofatumumab Study

• Research type

  Research Study

• Full title

  Phase II Trial of Single Agent Ofatumumab in Relapsed / Refractoy Mantle Cell Lymphoma.

• IRAS ID

  39265

• Sponsor organisation

  Plymouth Hospitals NHS Trust

• Eudract number

  2009-017675-16

• Research summary

  Mantle Cell Lymphoma (MCL) is a rare and aggressive form of Non-Hodgkin's Lymphoma (NHL). This is an incurable form of cancer that usually responds well to chemotherapy. However, when this disease relapses, further treatment is often disappointing with poor responses that often do not last for very long. The average age of presentation of MCL is in the mid 60's which makes intensive chemotherapy options of limited use. New therapies are needed. Ofatumumab is an antibody treatment that attaches to a molecule called CD20 which is located on the surface of MCL cells. This drug is similar to Rituximab which is used widely in Lymphoma and also works by attaching to CD20. Rituximab produces responses in about one third of patients with MCL but these responses are often short lived. Unlike many other forms of lymphoma, the addition of Rituximab to chemotherapy in MCL does not lend to an increase in survival. Ofatumumab has not been used in MCL; it does produce different responses to Rituximab when used in similar conditions and this study will assess the activity and safety of Ofatumumab in this condition. If this drug is active then combination studies with forms of chemotherapy will follow.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  10/H0106/66

• Date of REC Opinion

  30 Nov 2010

• REC opinion

  Further Information Favourable Opinion