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Clinical Trials associated with Rituximab biosimilar (Chia-tai Tianqing)TQ-B3525治疗复发/难治性滤泡性淋巴瘤(FL)的单臂、多中心II期临床试验
[Translation] A single-arm, multicenter phase II clinical trial of TQ-B3525 in the treatment of relapsed/refractory follicular lymphoma (FL)
1.主要目的
评估TQ-B3525治疗复发/难治性滤泡性淋巴瘤患者的有效性。
评估TQ-B3525联合利妥昔单抗和来那度胺(R2方案)治疗复发/难治性惰性非霍奇金B细胞淋巴瘤患者的II期推荐剂量(RP2D)。
2.次要目的
评估TQ-B3525在复发/难治性滤泡性淋巴瘤患者中的安全性。
评估TQ-B3525与疗效、作用机制/耐药机制、安全性相关的生物标志物。
评估TQ-B3525联合R2方案在治疗复发/难治性惰性非霍奇金B细胞淋巴瘤患者中的有效性。
评估TQ-B3525联合R2方案在治疗复发/难治性惰性非霍奇金B细胞淋巴瘤患者中的安全性。
评估TQ-B3525联合R2方案在治疗复发/难治性惰性非霍奇金B细胞淋巴瘤患者中TQ-B3525和来那度胺的药代动力学特征。
[Translation] 1. Primary Objectives
To evaluate the efficacy of TQ-B3525 in the treatment of patients with relapsed/refractory follicular lymphoma.
To evaluate the phase II recommended dose (RP2D) of TQ-B3525 combined with rituximab and lenalidomide (R2 regimen) in the treatment of patients with relapsed/refractory indolent non-Hodgkin's B-cell lymphoma.
2. Secondary Objectives
To evaluate the safety of TQ-B3525 in patients with relapsed/refractory follicular lymphoma.
To evaluate biomarkers associated with efficacy, mechanism of action/resistance mechanism, and safety of TQ-B3525.
To evaluate the efficacy of TQ-B3525 combined with R2 regimen in the treatment of patients with relapsed/refractory indolent non-Hodgkin's B-cell lymphoma.
To evaluate the safety of TQ-B3525 combined with R2 regimen in the treatment of patients with relapsed/refractory indolent non-Hodgkin's B-cell lymphoma.
To evaluate the pharmacokinetic characteristics of TQ-B3525 and lenalidomide in combination with R2 regimen in the treatment of patients with relapsed/refractory indolent non-Hodgkin's B-cell lymphoma.
Multicenter, Randomized, Double-blind, Parallel Controlled, Phase III Clinical Study to Compare the Efficacy and Safety of TQB2303 in Conbination With CHOP Regimen (T-CHOP) Versus Rituximab in Combination With CHOP Regimen (R-CHOP) in Previously Untreated Subjects With CD20-Positive Diffuse Large B-cell Lymphoma (DLBCL)
The Purpose of This Study is to Compare the Efficacy, Safety, Immunogenicity and Pharmacokinetics between TQB2303 and Rituximab in Combination With CHOP in Previously Untreated Patients with Diffuse Large B-cell Lymphoma
比较TQB2303与美罗华分别联合CHOP在弥漫性大B初治患者中疗效及安全性的临床研究
[Translation] A clinical study comparing the efficacy and safety of TQB2303 and Rituximab combined with CHOP in treatment-naive patients with diffuse large B-cell tumors
1.在DLBCL初治患者中,对比TQB2303联合CHOP和美罗华联合治疗后的临床有效性。 2.在DLBCL初治患者中,比较两组治疗的安全性。 3.在DLBCL初治患者中,比较TQB2303和美罗华的免疫原性。 4.分析TQB2303和美罗华在DLBCL患者中的群体药代动力学特征。
[Translation] 1. To compare the clinical efficacy of TQB2303 combined with CHOP and Rituxan in DLBCL patients who have never been treated. 2. To compare the safety of the two treatment groups in DLBCL patients who have never been treated. 3. To compare the immunogenicity of TQB2303 and Rituxan in DLBCL patients who have never been treated. 4. To analyze the population pharmacokinetic characteristics of TQB2303 and Rituxan in DLBCL patients.
100 Clinical Results associated with Rituximab biosimilar (Chia-tai Tianqing)
100 Translational Medicine associated with Rituximab biosimilar (Chia-tai Tianqing)
100 Patents (Medical) associated with Rituximab biosimilar (Chia-tai Tianqing)
100 Deals associated with Rituximab biosimilar (Chia-tai Tianqing)