CTRI/2010/091/001195已完成3 期
A Multicentric open label Phase III study to evaluate the Safety and Efficacy of Rituximab (Zenotech) in Non Hodgkin's Lymphoma, Version No. 3 dated 12th November 2009, supercedes Version No. 2 dated 12th May 2008
Zenotech Laboratories limited,8-2-120 /112 /88-89, Park View Estate, 4th Floor, Road No. 2, Banjara Hills, Hyderabad. Tel: +91 40 2354 0994Fax: +91 40 2355 54650 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- •Inclusion Criteria
- •Subjects must meet all of the following criteria to be included:
- •1.Subject has signed and dated informed consent document.
- •2.Subjects aged 18 years and above with one of the following diagnosis.
- •A. Relapsed or refractory low grade or follicular B-cell Lymphoma (International Working Formulation [IWF types A-D]-Rituximab naïve.
- •B. Previously untreated, FoIlicular, B-cell NHL (Rituximab in combination with CVP therapy) [IWF B-D].
- •C.Previously untreated, Diffuse large B-cell NHL (Rituximab in combination with CHOP therapy) [IWF G].
- •3.CD20 positive tumor.
- •4.Subject should have at least one measurable lesion (lesion size > 1cm × 1 cm) on CT scan.
- •5.Subjects with stage I to IV disease according to Modified Ann Arbor criteria.
- •6.Subjects with a performance status of 0-2 according to the Eastern Cooperative Oncology Group (ECOG).
- •7.Subjects expected to have a survival of 6 months or more (as per judgment of investigator).
- •8.At least four weeks have been passed from the last dose of the previous therapy and subject should have recovered from the significant toxicities of the prior therapy (as per the discretion of investigator).
排除标准
- •Exclusion Criteria
- •1.Subjects with history of T-cell Lymphoma.
- •2.Subjects with known history of anaphylaxis or hypersensitivity to murine proteins or to any component of the investigational product.
- •3.Subjects with CNS involvement or CNS lymphoma.
- •4.Subjects with reduced renal function: creatinine level greater than 2 times of the upper normal limit (ULN), compromised liver function: total bilirubin level greater than 2.5 mg/dL (>1.2 mg/dL in subjects diagnosed with diffuse large B cell lymphoma), AST/SGOT, ALT/SGPT or alkaline phosphatase level more than 3 times ULN), inadequate bone marrow reserve: hemoglobin concentration less than 8 g/dL, platelets  75000 cells/mm3 and ANC 1500 cells/mm3.
- •5.Subjects positive for HIV or hepatitis B or hepatitis C antigens.
- •6.Subjects with history of malignancy or concomitant malignancy (other than the study disease).
- •7.Subjects with history of clinically significant renal, hepatic, cardiovascular, haematologic (except the disease in consideration), endocrine, pulmonary, gastrointestinal, urogenital, psychiatric illness or severe mental retardation and progressive neurologic disease which in the opinion of the investigator may jeopardize the safety of the subject during the study or may interfere with the evaluation of efficacy of the study medication.
- •8.Subjects previously enrolled in this study.
- •9.Pregnant or breast-feeding women or women with positive urine pregnancy test at screening.
- •10.Subjects who are unable or unwilling to comply with the study procedures.
- •11.Subjects who have participated in another investigational study within the last 3 months prior to entry in this study.
- •Disease specific exclusion criteria
- •A. Relapsed or refractory low grade or follicular Non Hodgkin?s Lymphoma (Rituximab naïve)
- •1.Subjects who have received prior therapy with Rituximab
- •2.Subjects with history of more than four relapses following first therapy
- •B.Previously Untreated, FoIlicular CD 20-Positive, B-cell NHL
- •1.Subjects who have received any prior therapy for FoIlicular B-cell NHL.
- •2.Subjects with known history of anaphylaxis or hypersensitivity to cyclophosphamide, vincristine or prednisolone.
- •3.Subjects with history of clinically significant urine retention or significant bladder disease.
- •4.Subjects with history of epilepsy.
- •5.Subjects with history of demyelinating form of charcot-Marie-Tooth syndrome, significant peripheral neuropathies or any other disease of neuromuscular origin.
- •6.Concomitant use of succinyl choline, general anesthesia.
- •C.Previously Untreated, Diffuse Large B-Cell NHL
- •1.Subjects with known history of anaphylaxis or hypersensitivity to cyclophosphamide, vincristine, doxorubicin or prednisolone.
- •2.Subjects who have received any prior therapy for Diffuse large B-Cell NHL.
- •3.Subjects with history of clinically significant cardiac disease e.g., CHF, myocarditis, pericarditis or evidence of deterioration of cardiac function by ECHO cardiography (Left Ventricular Ejection Fraction (LVEF)  45%).
- •4.Subjects with history of significant urine retention or significant bladder disease.
- •5.Subjects with history of epilepsy.
- •6.Subjects with history of demyelinating form of charcot-Marie-Tooth syndrome or significant peripheral neuropathies.
- •7.Concomitant use of verapamil, succinyl choline, general anesthesia.
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