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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
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 ââ?°Â¥18 years and ââ?°Â¤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-Hodgkinââ?¬•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 ââ?°Â¥ 1500/mm3
- •ii.Platelet count ââ?°Â¥ 100,000/mm3
- •iii.Hemoglobin ââ?°Â¥ 9.0 g/dL
- •b.Renal Function: Serum Creatinine ââ?°Â¤ 1.5 times ULN
- •c.Hepatic Function:
- •i.Total bilirubin ââ?°Â¤1.5 Ã?â?? upper limit of normal (ULN); except if elevation is due to Gilbertââ?¬•s Syndrome with transitory elevations of indirect bilirubin.
- •ii.Alkaline phosphatase, alanine transaminase, and/or aspartate transaminase ââ?°Â¤3 Ã?â?? ULN or ââ?°Â¤5 Ã?â?? ULN in patients with liver involvement.
- •d.Left Ventricular Ejection Fraction (LVEF) ââ?°Â¥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 Ã?â?? 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-Hodgkinââ?¬•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)
研究者
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