A Phase II Comparative, Open-Label, Randomized, Multicenter, China-Only Study to Investigate the Pharmacokinetics, Efficacy and Safety of Subcutaneous Rituximab Versus Intravenous Rituximab Both in Combination With CHOP in Previously Untreated Patients With CD20 Positive Diffuse Large B Cell Lymphoma

This is a multicenter China-only study to investigate the PK, efficacy and safety of SC rituximab versus IV rituximab, both in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in previously untreated participants with CD20 positive DLBCL. Participants will be randomized to receive eight cycles of rituximab SC or rituximab IV combined with six or eight cycles of standard CHOP chemotherapy. After the end of study treatment, participants will be followed-up every 3 months for 6 months.

Start Date24 Feb 2021

Sponsor / Collaborator

Hoffmann-La Roche, Inc.

CTR20201740 / CompletedPhase 2

一项在既往未经治疗的CD20阳性弥漫性大B细胞淋巴瘤患者中比较利妥昔单抗皮下给药与利妥昔单抗静脉给药分别联合CHOP的药代动力学、有效性和安全性的II期、比较性、开放性、随机、多中心、仅中国研究

[Translation] A phase II, comparative, open-label, randomized, multicenter, China-only study comparing the pharmacokinetics, efficacy, and safety of subcutaneous rituximab versus intravenous rituximab combined with CHOP in patients with previously untreated CD20-positive diffuse large B-cell lymphoma

本研究将评价皮下注射（SC）利妥昔单抗与静脉注射（IV）利妥昔单抗分别联合环磷酰胺、多柔比星、长春新碱、泼尼松（CHOP）治疗既往未经治CD20阳性弥漫性大B细胞淋巴瘤（DLBCL）患者的有效性、安全性和药代动力学（PK）。

[Translation]

This study will evaluate the efficacy, safety, and pharmacokinetics (PK) of subcutaneous (SC) rituximab versus intravenous (IV) rituximab combined with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in patients with previously untreated CD20-positive diffuse large B-cell lymphoma (DLBCL).

Start Date18 Feb 2021

Sponsor / Collaborator

F. Hoffmann-La Roche Ltd.

[+2]

NCT05040906 / Unknown statusPhase 3

A Phase 3, Randomized, Double-blind Study of H02 Plus CHOP Versus R-CHOP in Patients With Diffuse Large B-cell Lymphoma

This trial is a Multicenter, randomized, double-blind, parallel, controlled, and equivalence phase Ⅲ study.
Primary objective:
The purpose is to compare the objective response rate of H02 (rituximab biosimilar) plus CHOP and rituximab plus CHOP, as first-line treatment of diffuse large B-cell lymphoma.
Secondary objective:
The purpose is to compare the safety of H02 combined with CHOP regimen and rituximab injection (Rituximab®) combined with CHOP regimen in the treatment of newly treated diffuse large B-cell lymphoma.

Start Date13 Oct 2020

Sponsor / Collaborator

Shandong New Time Pharmaceutical Co. Ltd.

100 Clinical Results associated with CD20 positive Diffuse Large B-Cell Lymphoma

100 Translational Medicine associated with CD20 positive Diffuse Large B-Cell Lymphoma

0 Patents (Medical) associated with CD20 positive Diffuse Large B-Cell Lymphoma

Literatures (Medical) associated with CD20 positive Diffuse Large B-Cell Lymphoma

01 Oct 2024·Journal for ImmunoTherapy of Cancer

Comparison of zuberitamab plus CHOP versus rituximab plus CHOP for the treatment of drug-naïve patients diagnosed with CD20-positive diffuse large B-cell lymphoma: a phase 3 trial

Article

Author: Song, Yuqin ; Yan, Feng ; Yang, Haiyan ; Zhang, Xiaohong ; Jin, Jie ; Zhang, Qingyuan ; Guo, Qunyi ; Gao, Sujun ; Cheng, Ying ; Zhao, Weili ; Yang, Wei ; Zhu, Jun ; Xiang, Ying ; Zhang, Mei ; Sun, Xiuhua ; Qian, Zhengzi ; Li, Zhiming ; Yang, Yu ; Lin, Lie ; Zhang, Donghua ; Jiang, Wenqi ; Lv, Fangfang ; Li, Wenyu ; Xu, Bing ; Yu, Ding ; Zhang, Mingzhi ; Wang, Zhao ; Zhou, Min ; Shen, Jianzhen ; He, Chuan ; Zhang, Liling ; Jing, Hongmei ; Zhao, Hongguo ; Liu, Huilan ; Wang, Jingbo ; Liu, Lihong ; Feng, Ru ; Cen, Hong ; Zhong, Meizuo ; Wang, Jishi ; Zhou, Hui ; Zhang, Weihua ; Huang, Yunhong ; Zhu, Xiongpeng

BackgroundIn patients with untreated CD20-positive diffuse large B-cell lymphoma (DLBCL), a phase 3 trial was carried out to evaluate the efficacy and safety of zuberitamab plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone; Hi-CHOP) versus rituximab plus CHOP (R-CHOP) treatment regimens.MethodsIn a 2:1 ratio, eligible patients were assigned randomly to receive treatment of six cycles of either 375 mg/m2zuberitamab or rituximab together with conventional CHOP chemotherapy. The objective response rate (ORR) at C6D50 served as the primary endpoint, and a non-inferiority margin of 10% was established. The secondary endpoints included the complete response (CR) rate at C6D50, duration of response (DOR), progression-free survival (PFS) and event-free survival (EFS) judged by blinded-independent review committee (BIRC), overall survival (OS) and safety outcomes.ResultsOf the 487 randomized patients, 423 patients including 287 in the Hi-CHOP and 136 in the R-CHOP groups completed the C6D50 assessment. For the full analysis set (FAS) and per-protocol set (PPS), BIRC-assessed ORR at C6D50 for the Hi-CHOP and R-CHOP groups were 83.5% versus 81.4% and 95.3% versus 93.7%, respectively. The non-inferiority was confirmed as the lower limit of the two-sided 95% CI for the intergroup differences of −5.2% and −3.3%; both were >−10% in the FAS and PPS. The BIRC-assessed CR rate of Hi-CHOP was significantly higher in PPS (85.7% vs 77.3%, p=0.038), but comparable in FAS (75.2% vs 67.9%, p=0.092). After a median follow-up of 29.6 months, patients in the Hi-CHOP group had a slight advantage with regard to the DOR (HR 0.74, p=0.173), PFS (HR 0.67, p=0.057), EFS (HR 0.90, p=0.517) and OS (HR 0.60, p=0.059). Patients with the germinal-center B cell-like subtype who received Hi-CHOP exhibited statistically significant improvements in ORR (p=0.034) and CR rate (p=0.038) at C6D50, EFS (p=0.046) and OS (p=0.014). Treatment-emergent adverse event occurrence rates were comparable across groups (all p>0.05). Infusion-related responses occurred more often in the Hi-CHOP group (32.1% vs 19.9%, p=0.006), all of grade 1–3 severity.ConclusionsZuberitamab (375 mg/m2) plus CHOP was non-inferior to R-CHOP regarding ORR but exhibited a higher CR rate and was well tolerated in CD20-positive, previously untreated Chinese patients with DLBCL.Trial registration numberChinese Clinical Trial Registry, ChiCTR2000040602, retrospectively registered.

01 Jan 2023·Therapeutic Advances in Hematology

REFLECT: prospective multicenter non-interventional study evaluating the effectiveness and safety of Sandoz rituximab (SDZ-RTX; Rixathon^®) in combination with CHOP for the treatment of patients with previously untreated CD20-positive diffuse large B-cell lymphoma

Article

Author: Welslau, Manfred ; Otremba, Burkhard ; Wolff, Thomas ; Kubuschok, Boris ; Bryn, Galyna ; Topaly, Julian

Background: REFLECT is the first prospective study of Sandoz biosimilar rituximab (SDZ-RTX) in patients with diffuse large B-cell lymphoma (DLBCL). Objective: To evaluate the 2-year effectiveness and safety of SDZ-RTX as first-line treatment for DLBCL. Design: Real-world, multicenter, open-label, single-arm, non-interventional, post-approval study of SDZ-RTX in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with treatment-naïve CD20‑positive DLBCL. Methods: Treatment-naïve, CD20-positive adult patients (⩾18 years) with DLBCL eligible for therapy with R-CHOP were treated with SDZ-RTX-CHOP every 2 or 3 weeks for 6–8 cycles. The effectiveness of SDZ-RTX was measured by the complete response (CR) rate at the end of R-CHOP treatment, as assessed by the treating physician. Progression-free survival (PFS) was assessed at 24 months. Results: A total of 169 patients [52.1% female, median (range) age 70 (24−94) years] with DLBCL were included in the full analysis set. At baseline, 19.5% and 24.3% of patients had Ann Arbor disease stage III or IV, respectively, and most patients (80.5%) had Eastern Cooperative Oncology Group Performance Status of 0 or 1. A total of 100 (59.2%) patients completed the 24-month observation period. In total, 110 [65.1%; 95% confidence interval (CI): 57.4–72.3] patients achieved CR as best response and 50 (29.6%; 95% CI: 22.8–37.1) patients achieved partial response. Overall best response rate was 94.7% (95% CI: 90.1–97.5). One-year PFS was 84.9% (95% CI: 78.2–89.6), while 2-year PFS was 78.5% (95% CI: 70.9–84.4); median PFS was not reached within the observational period. A total of 143 (84.6%) patients experienced ⩾1 adverse event, 53 (31.4%) of which were suspected to be related to study drug. Conclusion: This real-world, 2-year study reconfirms that first-line treatment of CD20-positive DLBCL with R-CHOP using SDZ-RTX is effective and well tolerated. Registration: N/A

01 Dec 2022·Hematological Oncology

Comparison of efficacy and safety of ripertamab (SCT400) versus rituximab (Mabthera^®) in combination with CHOP in patients with previously untreated CD20‐positive diffuse large B‐cell lymphoma: A randomized, single‐blind, phase III clinical trial

Article

Author: Gai, Wenlin ; Hao, Miaowang ; Xi, Yaming ; Ke, Xiaoyan ; Tang, Yun ; Gao, Yuhuan ; Zhang, Qingyuan ; Shen, Lida ; Wu, Hui ; Chen, Shaoshui ; Chang, Chunkang ; Yang, Linhua ; Yang, Haiyan ; Zheng, Zhendong ; Hong, Xiaonan ; Gui, Lin ; Cen, Hong ; Zou, Liqun ; Wang, Zhao ; Shi, Yuankai ; Ji, Yanan ; Zhang, Weihua ; Feng, Jifeng ; Zheng, Chengyun ; Xie, Liangzhi ; Zhang, Liling ; Wang, Zhen ; Jin, Chuan ; Li, Xiaoling ; Hu, Jianda ; Gao, Yajie ; Zhang, Liangming ; Zhang, Mingzhi ; Huang, Yunhong ; Li, Yufu

AbstractThis study compared the efficacy, safety and immunogenicity of ripertamab (SCT400) and rituximab (Mabthera®) combined with CHOP as the first‐line treatment for Chinese patients with CD20‐positive diffuse large B cell lymphoma (DLBCL). This is a randomized, patient‐blind, multicenter, active‐control, non‐inferiority study with parallel design. Patients were randomly (2:1) to receive ripertamab combined with CHOP (S‐CHOP) or rituximab (Mabthera®) combined with CHOP (R‐CHOP) for up to 6 cycles. The primary endpoint was the Independent Review Committee (IRC) assessed objective response rate (ORR) in full analysis set (FAS) and the per protocol set (PPS). A total of 364 patients (243 in the S‐CHOP and 121 in the R‐CHOP groups) were enrolled in this study. In FAS, IRC‐assessed ORRs were 93.8% (95% confidence interval (CI) 90.0%, 96.5%) and 94.2% (95% CI: 88.4%, 97.6%) in the S‐CHOP and R‐CHOP groups (p = 0.9633), respectively. The ORR difference between the two groups −0.4% (95% CI: −5.5%, 4.8%) met the pre‐specified non‐inferiority margin of −12%. There were no significant differences between the S‐CHOP and R‐CHOP groups in 1‐year progression‐free survival rates (81.1% vs. 83.2%, p = 0.8283), 1 year event‐free survival rates (56.2% vs. 58.1%, p = 0.8005), and 3‐year overall survival rates (81.0% vs. 82.8%, p = 0.7183). The results in PPS were consistent with those in FAS. The rates of treatment‐emergent adverse events (TEAEs) and ≥ grade 3 TEAEs were 97.9% and 99.2%, 85.2% and 86.0% in the S‐CHOP and R‐CHOP groups, respectively in safety set. The percentage of anti‐drug antibodies positive patients in the S‐CHOP group was numerically lower than the R‐CHOP group (10.9% vs. 16.0%). This study demonstrated that S‐CHOP was not inferior to R‐CHOP in the first‐line treatment of Chinese patients with CD20‐positive DLBCL in efficacy, safety and immunogenecity. S‐CHOP could be an alternative first‐line standard treatment regimen for this patient population.

News (Medical) associated with CD20 positive Diffuse Large B-Cell Lymphoma

13 Sep 2023

·www.prnewswire.com

Zuberitamab (Anruixi®), the first domestically developed anti-CD20 antibody as a Class I innovative drug from BioRay Pharmaceutical, has been approved for marketing in China

SHANGHAI, Sept. 13, 2023 /PRNewswire/ -- Recently, BioRay Pharmaceutical Co., Ltd. (hereinafter referred to as "Bioray") announced that its independently developed Class I innovative therapeutic biological product, Zuberitamab Injection (trade name: Anruixi®), indicated for the treatment of CD20-positive diffuse large B-cell lymphoma (DLBCL), was officially approved for marketing by the National Medical Products Administration (NMPA). In preclinical studies, Anruixi® showed stronger antibody-dependent cell-mediated cytotoxicity (ADCC), a larger volume of distribution at steady state, and more sustained clearance of B cells, demonstrating better efficacy compared to other products. Positive results were observed in a randomized, double-blind, active-controlled phase III clinical trial of Anruixi®, conducted in 43 study sites nationwide with 487 subjects enrolled. In the head-to-head study with Rituximab, the overall response rate of Anruixi® + CHOP was not inferior to that of R-CHOP in patients with early-stage DLBCL, and it had a significantly higher complete response rate vs. R-CHOP. In terms of long-term survival benefits, the Anruixi® group achieved better 1-year, 2-year, and 3-year PFS and OS rates compared with the Rituximab group. As the first domestically developed Class I anti-CD20 drug in China, Anruixi® will become BioRay's next major product following Anruize®. Additionally, clinical research is being conducted to explore the use of Anruixi® in the field of autoimmune diseases, such as primary immune thrombocytopenia (ITP). "As the company's sixth product on the market and its first new drug in the field of tumor immunology，we are particularly grateful for the tremendous efforts made by the clinical researchers who participated in the product's clinical study, our partners, and our colleagues at Bioray." said Dr. Haibin Wang, CEO of Bioray. "In the future, Bioray will continue to focus on the field of immunology and the unmet medical needs, providing more clinical treatment options, and bringing more medical solutions to patients." About BioRay BioRay is a pioneer in China's biopharmaceutical industry focusing on immune-mediated diseases. Its extensive autoimmune and oncology portfolio includes six marketed products and over 10 clinical-stage drug candidates. Operating a fully integrated platform with end-to-end capabilities across drug discovery, clinical development, manufacturing, and commercialization, BioRay has over 1,700 employees globally, with main sites in Taizhou, Hangzhou, Shanghai, and San Diego. For more information about BioRay, please visit the company website: SOURCE BioRay Pharmaceutical Co., Ltd

Clinical ResultDrug ApprovalImmunotherapyPhase 3Phase 1

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