BI 695500 plus chemo vs rituximab plus chemo in Lymphoma-Study 1301.2

• Research type

  Research Study

• Full title

  A randomized, double-blind, multi-center, multi-national Phase III trial to compare efficacy and safety of BI 695500 plus chemotherapy versus rituximab plus chemotherapy in patients with untreated follicular non-Hodgkin’s lymphoma.

• IRAS ID

  104203

• Contact name

  David Cunningham

• Sponsor organisation

  Boehringer Ingelheim International GmbH

• Eudract number

  2011-002908-33

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Non-Hodgkin??s lymphoma (NHL), a group of cancers arising from lymph tissue, is one of the leading causes of cancer death in the United States and Europe. Follicular lymphoma is one of the most common slow growing NHLs, accounting for approximately 20-25% of all lymphomas. Rituximab (brand name Rituxan© in the US and MabThera© in the EU) has received regulatory approval as the first monoclonal antibody anti-cancer drug. A monoclonal antibody is a type of protein made in a laboratory that can find and attach to certain substances in the body. In the case of NHL, it can bind to the surface of lymphoma cells and by binding; it triggers the body??s immune system to destroy the lymphoma cells. Rituximab is used in combination with other chemotherapy for the treatment of follicular lymphoma. Study drug, BI 695500, is being developed as a proposed Biosimilar to MabThera© and Rituxan© in terms of composition, strength and administration route as well as safety, purity and potency. Biosimilar products have already been developed and approved in certain indications, and are not new to the pharmaceutical industry. However, there is a clear need for biosimilar development in the field of monocolonal antibodies as a cost-saving option for patients and health care systems worldwide. Biosimilars will offer a lower cost treatment option, allowing patients to access/start treatment earlier as well as provide access to these medications in countries where they may not be accessible today. The purpose of this study is to see whether BI 695500 plus chemotherapy is similar to rituximab (MabThera©) plus chemotherapy in terms of effectiveness and safety for the treatment of follicular lymphoma. The study will include about 530 patients worldwide, it will be conducted in many countries around the world and each participant will be on study for up to 2 years and 7 months.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/1336

• Date of REC Opinion

  22 Jan 2013

• REC opinion

  Further Information Favourable Opinion