JPRN-jRCTs041190084进行中（未招募）2 期
Obinutuzumab plus bendamustine therapy in patients with relapsed follicular lymphoma: a single armed, multicentre, phase 2 trial - HMCSG-GB-RRF
Hirokazu Nagai0 个研究点目标入组 50 人开始时间: 2019年11月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 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
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1) Relapsed, histologically confirmed CD20-positive follicular lymphoma (Grades 1, 2, or 3A)
- •(2) Eastern Cooperative Oncology Group (ECOG) performance status score 0-2
- •(3) Aged 20 years or older at the time of informed consent
- •(4) Relapsed after one or two rituximab-containing chemotherapies
- •(5) Advanced stage follicular lymphoma at prior or second combination chemotherapies with Rituximab
- •(6) Rituximab sensitive
- •(7) If the participant has received prior Rituximab plus Bendamustine therapy, response duration must have been greater than 1 year without progression
- •(8) At least one bi-dimensionally measurable lesion on imaging scan(Measurable in two orthogonal directions with CT scan, and maximum diameter of the tumor is more than 1.5 cm
- •(9) Absolute neutrophil count (ANC) >= 1,000 /mm3 and platelets >= 75,000/mm3
- •(10) Patients who provided written informed consent
排除标准
- •(1) Histologically proven or clinically suspected histological transformation
- •(2) Limited stage and meet criteria for low tumor burden at enrolment
- •(3) History of myocardial infarction within the last 6 months, or unstable angina
- •(4) Positive test results for chronic hepatitis B virus (HBV) infection and HBV-DNA 2.1 log copies/mL or more, or for hepatitis C virus (HCV) antibody, or human immunodeficiency virus andibody
- •(5) Evidence of laboratory abnormalities, aspartate aminotransferase or alanine aminotransferase concentration 100IU/L or more, total bilirubin 2.0mg/dl or more, or creatinine 2.0 mg/dl or more
- •(6) Women who are pregnant or who desire pregnant
- •(7) Prior history of malignancies, unless the patient has been free for at least 5 years
- •(8) Any serious medical condition, laboratory abnormality or psychiatric illness that the investigator or subinvestigator would judge inadequate to participate
研究者
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