BP22333 Phase 1b Rituximab SC as Maintenance Treatment in fNHL (FL)

• Research type

  Research Study

• Full title

  A two-stage phase Ib study to investigate the pharmacokinetics, safety and tolerability of rituximab subcutaneous (SC) formulation in patients with follicular lymphoma (FL) as part of maintenance treatment.

• IRAS ID

  19612

• Eudract number

  2008-008490-60

• ISRCTN Number

  NA

• Research summary

  Rituximab SC in Maintenance Follicular lymphoma (FL):FL is the most common type of slow-growing Non-Hodgkin??s lymphoma, NHL, (a disease of the lymphatic system when a particular type of white cell, called a lymphocyte, becomes cancerous). FL may cause very few symptoms initially; the most common being painless lumps or swellings in the neck, armpit or groin.Roche presently markets MabThera (rituximab), as an intravenous (IV) infusion that is given over 1.5 to 4 hours. A more convenient formulation is planned, enabling the administration of rituximab as a 5 to 15ml injection over 3 to 10 minutes, with fewer or less intense infusion-related reactions.Roche is developing and funding a subcutaneous (SC) injection formulation of rituximab using human hyaluronidase, rHuPH20, Hylenex©. Hyaluronidase is a compound that increases the injection volume that can be injected under the skin and increases absorption of rituximab. Patients for this study will have completed and responded to their FL induction treatment, and will have started up to 24 months of maintenance therapy with rituximab. In Stage 1 of the study (dose finding), patients will be randomised to either rituximab IV or to 2 or 3 doses of rituximab SC. The rituximab SC dose that results in comparable rituximab blood concentrations to IV dose will be selected for Stage 2. In Stage 2 of the study (dose confirmation), patients will be randomised to either rituximab IV or the selected SC dose, to confirm that the selected SC dose of rituximab SC is equivalent to the IV dose.After the patients have completed the maintenance treatment or withdrawn from treatment, all patients will be followed-up for 9 months for safety. A patient will be on study for up to 30 months.This is an international study with 5 centres planned in the UK.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  09/H1010/37

• Date of REC Opinion

  9 Sep 2009

• REC opinion

  Further Information Favourable Opinion