IELSG 32

• Research type

  Research Study

• Full title

  Randomized phase II trial on primary chemotherapy woth high-dose methotrexate and high-dose cytarabine with or without thiotepa, and with or wothout rituximab, followed by brain irradiation vs high-dose chemotherapy supported by autologous stem cells transplantation for immunocompetent patients with newly diagnosed primary CNS lymphoma.

• IRAS ID

  68403

• Sponsor organisation

  Southampton University Hospitals NHS Trust

• Eudract number

  2009-012432-32

• ISRCTN Number

  not sent

• Research summary

  Primary central nervous system (PCNS) lymphoma is a cancer of the lymphatic system that's located in the brain. The most effective treatment is chemotherapy but high dose chemotherapy which can penetrate into the brain is required. Currently the treatment usually consists of high dose chemotherapy followed by radiotherapy to the brain. A new treatment programme for patients with PCNS may be a more effective combination for the condition and also incur less toxicity (unpleasant side-effects). Therefore we have devised a protocol that contains other anti-lymphoma drugs that have been shown in several studies to have a beneficial effect in patients with Non-Hodgkin's lymphoma.The best combination of currently available chemotherapy includes the administration of two agents, high dose methotrexate and cytarabine. The combination of these two drugs has been shown to be more effective than high-dose methotrexate alone. A third drug, thiotepa, is also effective in the brain when given separately and the addition of this agent to methotrexate and cytarabine may further improve the overall effectiveness of the treatment.Rituximab, a monoclonal antibody directed against lymphocytes, is directed against a protein expressed on the surface of the lymphoma cells, causing them to die and also sensitising them to the effects of chemotherapy drugs. The addition of Rituximab to chemotherapy has been shown to improve the survival of patients treated for some types of B-cell non-Hodgkin lymphoma outside the brain. The combination of rituximab to high dose methotrexate and cytarabine could also bring an additional benefit in treating PCNSL.After high-dose chemotherapy, whole brain radiotherapy is routinely offered to patients but the combination has been associated with problems (particularly ??neurotoxicity) later. We are also asking if high-dose chemotherapy followed by autologous peripheral stem cell transplantation is more effective or better tolerated than radiotherapy.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  11/LO/0420

• Date of REC Opinion

  29 Jun 2011

• REC opinion

  Further Information Favourable Opinion