JPRN-jRCTs031180257已完成2 期
JCOG0203: Rituximab + standard CHOP (R S-CHOP) vs Rituximab + bi-weekly CHOP (R Bi-CHOP) RCT(phase II/III) low-grade B-cell lymphoma at advanced stage - LowBNHL-RS/BiCHOP-P2/3
AGAI Hirokazu0 个研究点目标入组 300 人开始时间: 2019年3月13日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
R-CHOP was safe and efficacious without increasing fatal hematologic malignancies in the long-term and may, therefore, be a reasonable option as frontline therapy for advanced-stage FL.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 69age old（—）
- 性别
- All
入选标准
- •(1) Histological confirmed, low-grade B-cell lymphoma
- •(2) CD20-positive by flow cytometry or immunohistochemistry
- •(3) Ann Arbor CS III or IV
- •(4) Lymphoma cell count in PB<=10,000/mm3
- •(5) 20<=age<=69
- •(6) ECOG PS 0-2
- •(7) Having measurable leisions
- •(8) No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
- •(9) Normal BM, hepatic, renal, cardiac, and pulmonary function
- •(10) Written informed consent
排除标准
- •(1) CNS involvement
- •(2) Glaucoma
- •(3) DM treated by insulin
- •(4) Uncontrolable HT
- •(5) AP, AMI, cardiomyopathy, arrhythmia
- •(6) Positive HBs antigen
- •(7) Seropositive to HCV
- •(8) Seropositive to HIV
- •(9) Interstitial pneumonitis, pulmonary fibrosis, or severe emphysema
- •(10) Severe infection
- •(11) Liver cirrhosis
- •(12) Double cancer
- •(13) Pregnant or lactating
- •(14) Patients who desire auto PBST after CR
- •(15) Patients treated with major tranquilizer or antidepressant for severe mental disease
研究者
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