Prospective, multi-centric, open-label, two-arm, parallel group, active-control, randomized, comparative clinical study to evaluate efficacy and safety of R-TPR-017 / MabThera®(Ristova®) in patients with Non-Hodgkins Lymphoma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 26
- 主要终点
- Efficacy will be assessed as Objective Response Rate (Complete Response and Partial Response) assessed by RECIST 1.1 criteria
研究概览
简要总结
This was a prospective, multi-centric, open label, two arm, parallel group, active control, randomized, comparative clinical study to evaluate the efficacy and safety of R-TPR-017/ Mabthera® (Ristova®) in patients with Non Hodgkin’s Lymphoma. The analysis of primary efficacy end point i.e.ORR at week 24 shows comparable response for both R-TPR-017 and MabThera®(Ristova®) arm (87.87% Vs. 86.86%). The proportions of subjectsshowing ORR in each arm were compared for statistical significance and thedifference was found to be non-significant.The safety and efficacy of the R-TPR-017 was comparable to Mabthera® (Ristova®) in terms of ORR, progression free survival and overall survival. The adverse events for both treatment groups wereconsistent with the known safety profile of R-CHOP. No new safety concerns wereidentified with respect AE in either arm in this study. Thus R-TPR-017 was found to be comparable in terms of safety and efficacy in patients with newly diagnosed diffuse large-B-cell lymphoma or follicular lymphoma.
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
- •Previously untreated patients
- •Histologically confirmed, newly diagnosed follicular B cell Non-Hodgkins lymphoma or diffuse large B cell Non-Hodgkins lymphoma
- •CD20 positive by immunohistochemistry
- •Patients with at least one target lesion (lymph node with short axis of less than or equal to 15 mm by CT scan with contrast)
- •ECOG performance status 0 to 2
- •Life expectancy more than six months
- •Able to comprehend and give informed consent for the study and willing to come for follow up visit as per protocol requirements
- •Consent from Legally Acceptable Representative (LAR), if subject is not in a condition to give consent.
- •However, when the subject is stable and is able to give consent, the consent would be obtained on a separate ICF to confirm his/her willingness to continue participation in the study.
排除标准
- •Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis)
- •Patients with prior or concomitant malignancy
- •Patients with abnormal laboratory parameters like: •Serum creatinine 2.0 times of upper normal limit •AST or ALT 2.5 times of upper normal limit •Alkaline phosphatase ≥1.5 times of upper normal limit •Platelet count 100,000/ZL.
- •â€¢Hemoglobin 8.0 g/dL.
- •â€¢Absolute Neutrophil Count (ANC) 1.5 x 109 /L.
- •History of prior chemotherapy, stem cell transplant and radiotherapy
- •History of high dose, systemic, steroid therapy within 6 weeks
- •Previous use of non-human monoclonal antibody therapy and or known hypersensitive to murine proteins
- •Serious underlying medical condition which could impair the ability of patient to participate in the trial (e.g. Active systemic infection)
- •Severe cardiovascular disease within 12 months including myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, life threatening arrhythmias or uncontrollable hypertension
- •Pregnant or lactating females or women of child-bearing potential, unwilling or unable to use proper contraceptive precautions during the study
- •Subjects with HIV, HBsAg, HCV test positive
- •Subject participation in another clinical trial 30 days prior to administration of IP
- •Any other condition which the Investigator feels would pose a significant hazard to subject if IP is administered.
结局指标
主要结局
Efficacy will be assessed as Objective Response Rate (Complete Response and Partial Response) assessed by RECIST 1.1 criteria
时间窗: at 24 weeks
次要结局
- Proportion of patients with Objective Response Rate {Complete Response and Partial Response} assessed by RECIST 1.1 criteria(At 10 weeks, 24 weeks, 1year, 1.5 year and 2 year)