CTRI/2011/12/002232已完成3 期
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
- 106
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. Previously untreated patients
- •2. Histologically confirmed, newly diagnosed follicular B cell Non-Hodgkins lymphoma or diffuse large B cell Non-Hodgkins lymphoma
- •3. CD20 positive by immunohistochemistry
- •4. 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)
- •5. ECOG performance status 0 to 2
- •6. Life expectancy more than six months
- •7. Able to comprehend and give informed consent for the study and willing to come for follow up visit as per protocol requirements
- •8. 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
- •1. Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningitis)
- •2. Patients with prior or concomitant malignancy
- •3. 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.
- •Hemoglobin 8.0 g/dL.
- •Absolute Neutrophil Count (ANC) 1.5 x 109 /L.
- •Serum Immunoglobulin G (IgG) level 3.0 g/L
- •4. History of prior chemotherapy, stem cell transplant and radiotherapy
- •5. History of high dose, systemic, steroid therapy within 6 weeks
- •6. Previous use of non-human monoclonal antibody therapy and or known hypersensitive to murine proteins
- •7. Serious underlying medical condition which could impair the ability of patient to participate in the trial (e.g. Active systemic infection)
- •8. 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
- •9. Pregnant or lactating females or women of child-bearing potential, unwilling or unable to use proper contraceptive precautions during the study
- •10. Subjects with HIV, HBsAg, HCV test positive
- •11. Subject participation in another clinical trial 30 days prior to administration of IP
- •12. Any other condition which the Investigator feels would pose a significant hazard to subject if IP is administered
研究者
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