GP2013 in patients with previously untreated, advanced lymphoma.

• Research type

  Research Study

• Full title

  A randomized, controlled, double-blind Phase III trial to compare the efficacy, safety and pharmacokinetics of GP2013 plus cyclophosphamide, vincristine, prednisone vs. MabThera® plus cyclophosphamide, vincristine, prednisone, followed by GP2013 or MabThera® maintenance therapy in patients with previously untreated, advanced stage follicular lymphoma.

• IRAS ID

  112707

• Contact name

  Edward Kanfer

• Contact email

  e.kanfer@imperial.ac.uk

• Sponsor organisation

  HEXAL AG (A Sandoz company)

• Eudract number

  2010-019522-13

• ISRCTN Number

  n/a

• Research summary

  This is a randomized, controlled, double-blind Phase III trial to compare the efficacy, safety and pharmacokinetics of GP2013 plus cyclophosphamide, vincristine, prednisone versus MabThera® plus cyclophosphamide, vincristine, prednisone,
  followed by GP2013 or MabThera® maintenance therapy in patients with previously untreated, advanced stage follicular lymphoma. GP2013 is a ‘biosimilar’ product, which is similar, but not identical to a standard treatment of advanced stage follicular lymphoma, MabThera®. Approximately 618 patients will be randomised in about 180 centres around the world in 1:1 ratio to receive either GP2013-CVP or MabThera®-CVP.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  13/SC/0311

• Date of REC Opinion

  5 Jul 2013

• REC opinion

  Further Information Favourable Opinion