CTRI/2018/07/014885已完成3 期
Randomized, Assessor-Blind, Multicentre, Parallel Group, Two Arms, Clinical Study to Assess the Efficacy, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Safety of Rituximab (Test Product, Zydus) in comparison with Rituximab (Reference Product, Roche/Genentech) in Patients with Diffuse Large B Cell Lymphoma (DLBCL)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 33
- 主要终点
- Overall Response Rate (i.e., CR + PR) by using International Working Group Response Criteria for Malignant Lymphoma
研究概览
简要总结
This is Randomized, Assessor-Blind, Multicentre, ParallelGroup, Two Arms, Clinical Study to Assess the Efficacy, Pharmacokinetics,Pharmacodynamics, Immunogenicity and Safety of Rituximab (Test Product, Zydus)in comparison with Rituximab (Reference Product, Roche/Genentech) in Patientswith Diffuse Large B Cell Lymphoma (DLBCL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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
- •1.The patient willing to give written, signed, and dated informed consent to participate in the study before initiating any study related procedures 2.Male or non-pregnant, non-lactating Female ≥18 years and ≤65 years of age (both inclusive) 3.Patients with at least one measurable lesion as per International Working Group Revised Response Criteria for Malignant Lymphoma 4.Untreated Newly diagnosed patients with a confirmed pathologic diagnosis of CD20+ large B cell-non-Hodgkin’s lymphoma (DLBCL).
- •5.Stage II-III or IV defined by the referring physician on the basis of the Cotswolds modification of the Ann Arbor classification.
- •6.Age-adjusted International Prognostic Index (IPI) score 0 or 1 7.Patients who are eligible for receiving Rituximab and CHOP 8.Patient must have an adequate bone marrow, renal, cardiac and hepatic function a.Bone marrow reserve: i.ANC ≥ 1500/mm3 ii.Platelet count ≥ 100,000/mm3 iii.Hemoglobin ≥ 9.0 g/dL b.Renal Function: Serum Creatinine ≤ 1.5 times ULN c.Hepatic Function: i.Total bilirubin ≤1.5 × upper limit of normal (ULN); except if elevation is due to Gilbert’s Syndrome with transitory elevations of indirect bilirubin.
- •d.Left Ventricular Ejection Fraction (LVEF) ≥50% determined by either ECHO or MUGA Scan 9.Subjects with a performance status of 0 to 2 according to the Eastern Cooperative Oncology Group (ECOG) 10.If capable of reproduction, patients and their partners must use contraceptive methods during the full duration of the study and for 12 months after discontinuation of study.
排除标准
- •1.Patient who has a history of hypersensitivity reactions with murine proteins or planned chemotherapy.
- •2.Bulky Disease (>10 cm on maximum dimension) or involves >1/3 of chest diameter (on radiographic imaging) 3.Patient with severely immunocompromised state.
- •4.Patient treated with prior therapies including but not limited to Anthracyclines, Rituximab, any other anti-CD-20 therapy or autologous or allogeneic stem cell transplantation 5.Any radiotherapy given for lymphoma or non-lymphoma before 30 days of randomization 6.Patients depending on systemic steroids for Non Lymphomatous condition 7.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) 8.Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections).
- •9.Cardiac contra-indication to Doxorubicin therapy: noncompensated heart failure, dilated cardiomyopathy, coronary heart disease with ST segment depression on electrocardiogram (ECG), myocardial infarction in the last 6 months.
- •10.Neurologic contra-indication to Vincristine as it is indicated in the SmPC: (e.g. peripheral neuropathy).
- •11.Chronic lung disease with hypoxemia (SpO2 Ë‚ 90%).
- •12.Severe uncontrolled hypertension (blood pressure more than 150/100 mm Hg), despite optimal medical treatment.
- •13.Severe uncontrolled diabetes mellitus (As defined by American Diabetes Association), despite optimal medical treatment.
- •14.Major surgery within 4 weeks of study start (i.e., randomisation) 15.Any other malignancy in the last 5 years other than Non-Hodgkin’s Lymphoma except skin cancer or carcinoma in situ of the cervix 16.Known History of drug addiction within last 1 year 17.The receipt of an investigational medicinal product or participation in other drug research study within a period of 30 days prior to the first dose of investigational medicinal product for the current study.
- •18.Any history or presence of clinically significant cardiovascular, respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic ,neurologic, or psychiatric disease or any other condition which in the opinion of the investigator could jeopardize the safety of the subject or the validity of the study results 19.Receipt of live vaccine within 4 weeks prior to study drug administration 20.Pregnant or breast-feeding patients (for female patients of child bearing potential).
结局指标
主要结局
Overall Response Rate (i.e., CR + PR) by using International Working Group Response Criteria for Malignant Lymphoma
时间窗: Timeframe: Baseline & at the end of cycle 6
次要结局
- 1.Overall Response Rate(2.Assessment of Pharmacokinetic parameters)
研究者
研究点 (33)
Loading locations...
相似试验
已完成
3 期
A clinical trial to study the effect of Fixed Dose Combination of Microsphere Tretinoin and Clindamycin gel in the treatment of patients with acne vulgaris.CTRI/2012/03/002472Glenmark Pharmaceuticals Ltd438
已完成
2 期
A Clinical Study of Efficacy, Safety, Tolerability and PK of ND0612H in Subjects With Advanced Parkinson's DiseaseParkinson's DiseaseNCT02577523NeuroDerm Ltd.38
已完成
不适用
The USGI Medical ESSENTIAL Study for Weight LossObesityNCT01958385USGI Medical377
已完成
3 期
A Clinical trial to check the effect, Safety and Tolerability of Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in patients with Ocular Hypertension / GlaucomaCTRI/2018/04/013091Ajanta Pharma Ltd240
Unknown
不适用
Postoperative Diet With Hyperproteic Supplement Versus a Supplement With Imunonutrients, in Colorectal Cancer SurgeryNutrition Related Neoplasm/CancerSurgery--ComplicationsSite InfectionNutrition SupportColorectal CancerNCT04059731Hospital General Universitario Reina Sofía de Murcia108