Randomized, Parallel-group, Double-blind, Comparative Bioequivalence Trial of MabionCD20 Compared to MabThera (Rituximab by Hoffman-La Roche) in Patients With Diffuse Large B-cell Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mabion SA
- 入组人数
- 143
- 试验地点
- 35
- 主要终点
- Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4])
研究概览
简要总结
The aim of the study is to demonstrate the high level of biosimilarity between MabionCD20 (MABION SA) and the reference product: MabThera (rituximab by Hoffman-La Roche) in patients with CD20-positive diffuse large B-cell lymphoma.
详细描述
Patients who meet criteria for participation in this study receive 8 intravenous infusions of MabionCD20® or MabThera® 21 days interval in combination with standard dosage regimen of CHOP. The duration of the study is 12 months. The treatment and observation period will last 26 weeks starting from Day 1, until Week 26 - one month after last IMP infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histological confirmed CD20 (cluster of differentiation 20) positive diffuse large B cell lymphoma (DLBCL)
- •Patients that had been diagnosed according to the WHO classification;
- •Performance status ≤ 2 on the ECOG (Eastern Cooperative Oncology Group) / WHO (world Health Organization) scale, performance status of 3 will be accepted if impairment is caused by DLBCL complications and improvement is expected once therapy is initiated;
排除标准
- •Life expectance less than 6 months;
- •Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment;
- •Rituximab, other anti-CD20 mAb (Monoclonal Antibodies) drug treatment, treatment with any cell depleting therapies - e.g., anti-CD4 (cluster of differentiation 4) anti-CD5 (cluster of differentiation 5), anti-CD3 (cluster of differentiation 3), anti-CD19 (cluster of differentiation 19), anti CD11 (cluster of differentiation 11), anti-CD22 (cluster of differentiation 11), BLys/BAFF (B Lymphocyte Stimulator/B-cell activating factor) within 1,5 years before screening;
研究组 & 干预措施
MabionCD20
A course of MabionCD20 consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.
Intervention: Drug: Rituximab
干预措施: Rituximab (Drug)
MabionCD20
A course of MabionCD20 consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.
Intervention: Drug: Rituximab
干预措施: Doxorubicin (Drug)
MabionCD20
A course of MabionCD20 consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.
Intervention: Drug: Rituximab
干预措施: Vincristine (Drug)
MabionCD20
A course of MabionCD20 consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.
Intervention: Drug: Rituximab
干预措施: Cyclophosphamide (Drug)
MabionCD20
A course of MabionCD20 consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.
Intervention: Drug: Rituximab
干预措施: prednisone (Drug)
MabThera
A course of MabThera consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.
Intervention: Drug: Rituximab
干预措施: Rituximab (Drug)
MabThera
A course of MabThera consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.
Intervention: Drug: Rituximab
干预措施: Doxorubicin (Drug)
MabThera
A course of MabThera consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.
Intervention: Drug: Rituximab
干预措施: Vincristine (Drug)
MabThera
A course of MabThera consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.
Intervention: Drug: Rituximab
干预措施: Cyclophosphamide (Drug)
MabThera
A course of MabThera consists of intravenous infusions in dose 375 mg/m2 body surface area, administered on day 1 of each chemotherapy cycle for 8 cycles.
Intervention: Drug: Rituximab
干预措施: prednisone (Drug)
结局指标
主要结局
Area Under the Serum Concentration-time Curve From Day 1 to Week 4 (AUC[1-4])
时间窗: Baseline to Week 4
Area under the serum concentration-time curve from time zero (Day 1) to final time point measured after the first administration (Week 1) until Week 4 (AUC(W1-W4)). PK blood samples for this endpoint were drawn at Day 1 (before and after the first infusion), Day 8 ± 1 (7 days after first infusion), Day 15 ± 1 (14 days after first infusion), Day 22 ± 2 (before and after completion of the second infusion).
Area Under the Serum Concentration-time Curve From Week 13 to Week 26 (AUC[W13-W26])
时间窗: Week 13 to Week 26
Area under the serum concentration-time curve from time zero to final time point measured from Week 13 until Week 26 (AUC\[W13-W26\]). PK blood samples for this endpoint were drawn at Day 85 ± 4 (before and after completion of the fifth infusion), Day 106 ± 4 (before and after completion of sixth infusion), Day 127 ± 4 (before and after completion of the seventh infusion), Day 148 ± 4 (before and after completion of the eight infusion), Day 155 ± 4 (one week after last infusion) and Day 176 ± 4 (one month after last infusion).
次要结局
- Kel (Post 5th and 8th Infusions)(Week 13 (5th infusion) and Week 22 (8th infusion))
- CLss (Post 5th and 8th Infusions)(Week 13 to Week 16 and Week 22 to Week 26)
- Ctrough (Before 8th Infusion)(Week 22)
- Efficacy Assessment at Week 26(Week 26)
- Adverse Events(from baseline to Week 46)
- T1/2 (Post 5th and 8th Infusions)(Week 13 to Week 16 and Week 22 to Week 26)
- Cmax (Post 5th and 8th Infusion)(Week 13 (5th infusion) and Week 22 (8th infusion))
- AUC (W1-W26)(Week 1 until Week 26)
- AUC (W1-W26) B-cell(baseline to Week 26)