KCT0003250招募中未知
Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma (NHL)
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Histologically confirmed indolent CD20-positive NHLs (iNHLs; follicular lymphoma grade 1-3a, marginal zone B-cell lymphoma, small lymphocytic lymphoma, Waldenstrom macroglobulinemia)
- •2. CD20-positive iNHL patients who relapsed or progressed: have to meet all of the following criteria (a+b):
- •a.At least two prior lines of chemotherapy
- •b.Relapsed or refractory for the last chemotherapy or radiotherapy; That is, relapsed during or after the treatement
- •3. Patients age = 19 years
- •4. ECOG PS 0-2 (appendix A)
- •5. At least one bidimensionally measurable disease (>1.5cm
- •defined by CT scan; presence of IgM paraproteinemia defined as a minimum IgM level = 2 x ULN for Waldenstrom macroglobulinemia)
- •6. Adequate hematologic, renal, and hepatic functions as defined by:
- •1) hemoglobin = 9 g/dL, absolute neutrophil count = 1.5 x 109/L, and platelets = 75 x 109/L (absolute neutrophil count = 1.0 x 109/L, platelets = 50 x 109/L if bone marrow involvement or hypersplenism due to the splenic involvement present)
- •2) Serum creatinine = 1.5 x ULN or calculated CrCL = 40 mL/min (Cockcroft Gault fomula)
- •3) Total bilirubin = 1.5xULN ( = 3.0xULN for Gilbert’s syndrome)
- •7. Women of child-bearing potential should use two appropriate methods of contraception during the study (diaphragm, use of condom by partner, intrauterine contraceptive device, sponge or spermicide) or in the status of surgical sterilization or maintain abstinence. Women of childbearing age should be negative in the pregnancy test within 14 days before treatment. Men should use appropriate method of contraception; such as use of condom and etc.
- •8. Written informed consent
排除标准
- •1. Not all of the above inclusion criteria are met.
- •2. Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks
- •3.Corticosteroids during last 28 days except chronic administration of prednisolone at a dose of =10mg/day for indications other than lymphomas
- •4. Evidence of CNS involvement by lymphomas
- •5. Active HBV/HCV infections, known HIV infection (In cases of HBcAb IgG-positivity, prophylactic antiviral treatment or close monitoring of HBV DNA titer is necessary)
- •6. Prior diagnosis of cancers within 5 years, except cervical intraepithelial neoplasia type 1, localized non-melanoma skin cancer, or small differentiated thyroid cancer, or early gastric cancer
- •7. Serious concurrent disease:
- •1) myocardial infarction and any cardiovascular events within 6 months prior to enrollment
- •2) uncontrolled hypertension despite adequate medication
- •3) serious congestive heart failure (NYHA functional classification III or V)
- •8. Patients who are pregnant or lactating
研究者
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