MO25455

• Research type

  Research Study

• Full title

  A randomized study comparing maintenance therapy with subcutaneous rituximab continued until progression with observation only in patients with relapsed or refractory, indolent non-Hodgkin's lymphoma who completed and responded to rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.

• IRAS ID

  82182

• Contact name

  George Follows

• Eudract number

  2010-023407-95

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Non-Hodgkin's Lymphoma (NHL) is one of the main causes of cancer death in Europe. NHL is classified into two categories, fast growing (aggressive) and slow growing (indolent). Most patients with an indolent NHL are diagnosed with advanced stage disease and cannot be cured as lymphoma invariably returns (relapse).There is a wide range of treatment options for indolent NHL and a significant improvement has been achieved through the introduction of treatment with targeted drugs such as rituximab (monoclonal antibodies) in combination with chemotherapy to the point that this has become the standard initial (also know as induction) therapy in first-line treatment of these types of NHL. Rituximab is also used, and continues to be investigated, in on-going treatment (maintenance), after response to induction therapy, to increase periods of remission between relapses in disease.Currently rituximab is given as an intravenous (IV) infusion (where a needle is placed into a vein) over several hours, the procedure requiring IV access on a regular basis. A number of other monoclonal antibodies have switched from IV to subcutaneous (SC) administration (an injection under the skin) with less side effects (safety) and equal response (efficacy).The objectives of this study are to measure the effectiveness and safety of a SC delivery of rituximab in patients with indolent NHL and to examine survival without disease progression.Patients who present with relapsed indolent NHL (Grade 1, 2 or 3a) will undergo treatment (40 in the UK, 700 worldwide) with SC rituximab over a period of approximately two and a half years. Patients will then either continue on SC rituximab or enter an observation phase (no study drug). Any patient displaying progressive disease during the study will be withdrawn and receive appropriate alternative care from their physician.The results of this study will help assess the efficacy and safety of SC rituximab in terms of period of remission (progression free survival) in NHL patients who either receive two and a half years SC rituximab and are then observed against those patients who continue to receive SC rituximab.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  11/EE/0311

• Date of REC Opinion

  17 Oct 2011

• REC opinion

  Further Information Favourable Opinion