Lymphoma, B-Cell Clinical Trial
Official title:
Safety and Activity of Rituximab(HLX01) in Combination With Pegylated Interferon α-2b in Patients With Newly Diagnosed Advanced Indolent B-cell Lymphoma: a Single-arm, Multicenter, Phase 2 Study
A phase 2 open label study to evaluate safety and activity of Rituximab(HLX01) in combination with Pegylated interferon α-2b in patients with newly diagnosed advanced indolent B-cell lymphoma.
Indolent B-cell lymphomas (iBCL), including follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL, including Waldenström macroglobulinemia), and some cases of mantle cell lymphoma (MCL), disproportionally affect older individuals.Treatment options are heterogeneous, varying from watchful waiting to intensive combination therapy. Historically, rituximab based regimens have been used as standard immunochemotherapy for iBCL.Use of immunotherapy for indolent lymphoma had been advocated for many years and several studies reported benefit with interferon (IFN) in combination with chemotherapy or rituximab. The positive rate of HBsAg in B-cell NHL is about 30% in China.Pegylated interferon contribute to convert HBsAg to negative. We aim to evaluate safety and activity of Rituximab(HLX01) in combination with Pegylated interferon α-2b in patients with newly diagnosed advanced iBCL and HBsAg clearance rate of hepatitis B patients. ;
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