A Randomized, Multiple-dose, Multicenter, Comparative Parallel Study To Evaluate The Efficacy, Safety And Pharmacokinetic Characteristics Of Intravenous Infusion Of Rituximab (Hetero) And Reference Medicinal Product (Rituximab, Roche) In Indian Patients Of Non-Hodgkins Lymphoma (HERILY Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 36
- 主要终点
- Overall Response rate (ORR) by International Working Group (IWG) response criteria
研究概览
简要总结
This study is an open label, randomized, multiple-dose, parallel study to evaluate the safety and efficacy of intravenous infusion of Rituximab Test product (Hetero) and Reference product in two clinical subtypes of Non-Hodgkin’s lymphoma (DLBCL & follicular) given along with CHOP chemotherapy. The primary objective is to compare the antitumor efficacy of Hetero-Rituximab with Reference Medicinal Product (Rituximab, Roche). The secondary objectives are to evaluate safety of the patients, compare the immunogenic potentials from baseline to the end of 3rd & 6thcycles of chemotherapy, to evaluate the pharmacokinetic characteristics at 1st & 6th cycles of chemotherapy, and compare the pharmacodynamics from baseline to the end of 3rd & 6th cycles of chemotherapy, between two formulations of Rituximab (test and reference).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures •Male or Female ≥18 years and ≤65 years of age (both inclusive) •Histologically confirmed CD20-positive- Newly diagnosed diffuse large B-cell Non-Hodgkin’s lymphoma OR Previously untreated patients with stage III-IV follicular lymphoma in combination with chemotherapy •Patients who are eligible for rituximab and CHOP •Patients with at least one measurable lesion as per International Working Group Response Criteria for Malignant Lymphoma •Adequate liver, renal, cardiac and haematological functions •Subjects with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) •Life expectancy more than six months •No other serious illness that according to investigator might jeopardize the well-being, the safety of study subjects, the compliance to study medications and validity of data generated during the study.
排除标准
- •â€¢ Hypersensitivity reactions with murine proteins or planned chemotherapy •Diffuse lymphoma for which CHOP is not adequate therapy •Bulky Disease (10 cm on maximum dimension) or involves 1/3 of chest diameter (on radiographic imaging) •Need for emergency therapy such as neurologic compression syndrome •Subjects with CNS involvement or CNS lymphoma (Diffuse large B-cell lymphoma that is primary CNS, effusional, or intravascular according to the WHO, 2008 classification) •Patient treated with prior chemotherapy including not limited to Anthracyclines, Rituximab, anti-CD-20 therapy or autologous or allogeneic stem cell transplantation •Any radiotherapy given for lymphoma or non-lymphoma before 30 days of planned treatment •Symptomatic peripheral neuropathy (≥Grade 2,Common Terminology Criteria of Adverse Events [CTCAE v 4.03) •Patients using systemic antibiotic therapy 30 days prior to screening.
结局指标
主要结局
Overall Response rate (ORR) by International Working Group (IWG) response criteria
时间窗: At baseline, end of cycle 3 and 6.
次要结局
- Pharmacodynamics: CD19 counts(Pharmacokinetics:Cmax, Tmax & AUC)