A randomized, double-blind, phase III study comparing Biosimilar Rituximab (RTXM83) plus CHOP chemotherapy versus a reference Rituximab plus CHOP (R-CHOP) in patients with diffuse large b-cell lymphoma (DLBCL) given as first line.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- MABXIENCE SA
- 入组人数
- 250
- 试验地点
- 14
- 主要终点
- (PD) according to the International Working Group criteria.
研究概览
简要总结
Arandomized, double-blind, phase III study comparing Biosimilar Rituximab (RTXM83)plus CHOP chemotherapy versus a reference Rituximab plus CHOP (R-CHOP) in patientswith diffuse large b-cell lymphoma (DLBCL) given as first line. This study will be initiated only after obtaining the approvals of Institutional/ Independent Ethics Committee (IEC). The subjects qualifying inclusion and exclusion criteria will be invited to participate in this study voluntarily. AnIndependent Data Monitoring Committee (IDMC) will assess periodically thesafety data and will recommend to the Sponsor whether to continue, modify orstop the trial. This decision will be based on safety considerations and/or theresults of planned interim analyses following pharmacological analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients with measurable disease defined as existence of a unidimensional or bidimensional lesion greater than 2 cm in its longest diameter or malignant lymphocytosis greater than 5x109/L.
- •Any other procedure for measurable disease in particular cases, may be allowed upon Sponsor approval.
- •2.Newly diagnosed patients with a confirmed pathologic diagnosis of large B cell-non-Hodgkin’s lymphoma (DLBCL) with untreated CD20+.
- •Defined by the local Haematopathologist at the local laboratory according to WHO criteria.
- •3.Stage II-III or IV or stage I with bulk defined by the referring physician on the basis of the Cotswolds modification of the Ann Arbor classification.
- •4.Age-adjusted International Prognostic Index (IPI) score 0 or
- •5.Age ≥18 to ≤65 years of age.
- •6.Performance status (Eastern Cooperative Oncology Group [ECOG]) of ≤
- •7.Written informed consent obtained before starting any study specific procedure.
- •8.Females of child-bearing potential must test negative on standard serum pregnancy test and must be willing to practice appropriate contraceptive methods for the duration of the study (e.g. oral contraceptive, double barrier method, intra-uterine device, intramuscular contraceptive).
排除标准
- •Life expectancy of less than three months.
- •Any other lymphoma other than CD20+ DLBCL.
结局指标
主要结局
(PD) according to the International Working Group criteria.
时间窗: Response Rate (RR): | Tumour responses will be assessed after 6 cycles of chemotherapy or | at the end of treatment and classified as Complete Response (CR), | Partial Response (PR), Stable Disease (SD) or Progressive Disease | (PD) according to the International Working Group criteria.
Response Rate (RR):
时间窗: Response Rate (RR): | Tumour responses will be assessed after 6 cycles of chemotherapy or | at the end of treatment and classified as Complete Response (CR), | Partial Response (PR), Stable Disease (SD) or Progressive Disease | (PD) according to the International Working Group criteria.
Tumour responses will be assessed after 6 cycles of chemotherapy or
时间窗: Response Rate (RR): | Tumour responses will be assessed after 6 cycles of chemotherapy or | at the end of treatment and classified as Complete Response (CR), | Partial Response (PR), Stable Disease (SD) or Progressive Disease | (PD) according to the International Working Group criteria.
at the end of treatment and classified as Complete Response (CR),
时间窗: Response Rate (RR): | Tumour responses will be assessed after 6 cycles of chemotherapy or | at the end of treatment and classified as Complete Response (CR), | Partial Response (PR), Stable Disease (SD) or Progressive Disease | (PD) according to the International Working Group criteria.
Partial Response (PR), Stable Disease (SD) or Progressive Disease
时间窗: Response Rate (RR): | Tumour responses will be assessed after 6 cycles of chemotherapy or | at the end of treatment and classified as Complete Response (CR), | Partial Response (PR), Stable Disease (SD) or Progressive Disease | (PD) according to the International Working Group criteria.
次要结局
- Event Free Survival: Time to progressive disease under therapy, the events for which being: progressive disease, no achievement of CR, PR associated with treatment in excess of that per protocol, SD, relapse after achievement of CR, death from any cause,(whichever comes first.)