Date: 2016-04-19
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Amgen (USA - CA)
Product: ABP 798 (biosimilar version of Mabthera®/Rituxan® - rituximab)
Action
mechanism: biosimilar/monoclonal antibody. ABP 798 is a biosimilar version of Mabthera®/Rituxan® - rituximab. Rituximabt binds to the CD20 antigen on the surface of normal and malignant B-cells and then recruits the body’s natural defenses to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months.
Disease: non-Hodgkin lymphoma
Therapeutic area: Cancer - Oncology
Country: Australia, Bulgaria, Canada, Czech Republic, France, Germany, Greece, Italy, Poland, Spain, New Zealand, USA
Trial
details: This trial is designed to determine what effects the human body has on ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with CD 20 positive B-cell non Hodgkin lymphoma. This study will assess if the investigational medicine is safe and effective in treating CD 20 positive B-cell non Hodgkin lymphoma. (NCT02747043)
Latest
news: * On April 19, 2016, a Phase 3 trial sponsored by Amgen was published on the NIH website ClinicalTrials.gov for ABP 798 (biosimilar version of Mabthera®/Rituxan® - rituximab) and is currently recruiting participants.
