A Phase III, Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination with Gemcitabine Plus Oxaliplatin Versus Rituximab in Combination with Gemcitabine and Oxaliplatin in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma - GO41944

F. Hoffmann-La Roche AG0 个研究点目标入组 245 人开始时间: 2024年4月12日最近更新: 2024年7月22日

试验速览

暂无简介。

•Life expectancy >= 12 weeks, Histologically confirmed diffuse large B-cell lymphoma, not otherwise specified (NOS), Relapsed/refractory disease, At least one line of prior systemic therapy, Patients who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant, At least one bi-dimensionally measurable (>= 1.5 cm) nodal lesion, or one bi-dimensionally measurable (=> 1 cm) extranodal lesion, as measured on CT scan

•Patient has failed only one prior line of therapy and is a candidate for stem cell transplantation, Contraindication to Obinutuzumab, rituximab, gemcitabine or oxaliplatin, or tocilizumab, History of transformation of indolent disease to DLBCL, High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines, Primary mediastinal B-cell lymphoma, History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products

发起方