STARLYTE: ARD10248 in patients with diffuse large B cell lymphoma

• Research type

  Research Study

• Full title

  An open label non-randomized phase 2 study evaluating SAR3419, an anti-CD19 antibody – maytansine conjugate, administered as single agent by intravenous infusion to patients with relapsed or refractory CD19+ diffuse large B cell lymphoma

• IRAS ID

  105118

• Contact name

  Martin Dyer

• Sponsor organisation

  sanofi-aventis recherche et developpement

• Eudract number

  2011-003657-26

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Diffuse large B cell lymphoma (DLBCL) is the most frequent non-Hodgkin lymphoma (NHL) representing 30 ?? 40% of newly diagnosed cases of lymphoma in adults. Despite major advances in therapy, lymphoma represent the 6th cause of cancer related deaths in many Western countries, and number of cases diagnosed with NHL is steadily increasing worldwide specially in the elderly. Patients presenting with Germinal Center B cell DLBCL have a high probability of responding to rituximab ?? CHOP chemotherapy and achieving a cure, whereas only about 50% of patients with Activated B Cell DLBCL can be considered cured. First line therapy of DLBCL consists of an anthracycline based combination (usually CHOP) combined with rituximab (R). With this combination, more than two thirds of patients achieve a response, of which 30% will relapse. Upon relapse, patients eligible for Autologous Stem Cell Transplant (ASCT) may achieve again durable responses. Patients with relapsed lymphoma for whom ASCT is not an option (the majority of relapsing patients) and patients relapsing after ASCT are currently not curable. There are several chemotherapy regimens active in relapsed disease but due to the emergence of resistance, the probability of achieving a response becomes lower and response duration becomes shorter with successive lines of therapy. Patients who fail to respond to chemotherapy or relapse within 6 months from its completion are considered to have refractory disease. These patients have a survival expectancy below 12 months. Thus, there is a clear medical need for new active and safe therapies for relapsed/refractory DLBCL. The study drug, SAR3419, binds to the B cell, is internalized and then releases killing agents inside the tumour B cells for it to die.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  12/EM/0206

• Date of REC Opinion

  27 Jun 2012

• REC opinion

  Further Information Favourable Opinion