Date: 2015-12-04
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Boehringer Ingelheim (Germany)
Product: BI 836826 in combination with gemcitabine and oxaliplatin (GemOx)
Action
mechanism: monoclonal antibody. BI 836826 is a chimeric monoclonal antibody against the tumor-associated antigen CD37. CD37, a member of the tetraspanin superfamily of cell surface antigens, is overexpressed on a variety of cancer cell types and plays a key role in tumor cell proliferation. High levels of CD37 are found on mature B-cell leukaemia and lymphoma cells.
Disease: diffuse large B-cell lymphoma (DLBCL)
Therapeutic area: Cancer - Oncology
Country: Belgium, Italy, Republic of Korea, Spain
Trial
details: This open label multicenter phase Ib/II Trial is to determine the dose of BI 836826 in combination with gemcitabine and oxaliplatin (GemOx) and the efficacy of BI 836826-GemOx versus Rituximab®- in combination with GemOx (R-GemOx) in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for, or have failed autologous stem cell transplant. The main objectives are to establish the MTD of BI836826 -GemOx and thereafter to compare the efficacy as Overall response (OR) based on the central review assessments of BI 836826- GemOx and R-GemOx in patients with relapsed DLBCL. The secondary objectives are to evaluate the pharmacokinetics of BI 836826 in combination with GemOx and to investigate and compare the efficacy as CR by way of central review assessments for BI 836-GemOx and R-GemOx in patients with relapsed DLBCL. (NCT02624492)
Latest
news: * On December 4, 2015, a Phase 2 trial sponsored by Boehringer Ingelheim was published on the NIH website ClinicalTrials.gov for BI 836826 and is currently recruiting participants.
