JPRN-jRCTs071180057已完成2 期
Clinical research on sequential combination therapy with CHOP and mogamulizumab in patients with untreated primary adult T cell leukemia-lymphoma - FBMTG MOG16
Kato Koji0 个研究点目标入组 24 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
研究概览
简要总结
A multicenter, single-arm study was conducted to investigate efficacy and safety on sequential combination of mogamulizumab after CHOP in patients with untreated primary adult T cell leukemia-lymphoma (ATL). The primary endpoint was the overall survival. The full analysis set was 24. The median survival time (80% CI) was 12.1 (5.0 - 21.0)months, and it was not statistically significant at the one-sided 0.10 level.
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) Patients with untreated primary ATL nonadaptive for transplantation (diagnosed by HTLV-1 antibody positive, hemocytologically/ histopathologically and surface character)
- •2) Patients with serum anti HTLV-1 antibody positive.
- •3) Patients with any of acute type, lymphoma type or chronic type with prognosis decision factor in ATL disease type categories.
- •4) Patients with more than 20 years old at the enrollment date.
- •5) Patients with performance status (ECOG) 0 - 2.
- •6) Patients with measurable lesion in Response Evaluation criteria of ATL (JCOG version).
- •7) Patients have met the following all latest clinical test standards within 14 days prior to enrollment (eligible on the same day of the last week of the enrollment day)
- •(1) Serum creatinine: < 2.0mg/dL (eligible in the case of neoplastic increase)
- •(2) AST, ALT, ALP: < 2.5 times of upper limit of normal.
- •(3) Total bilirubin < 2.0mg/dL
- •8) Patients providing the written informed consent.
排除标准
- •1) Patients with uncontrollable diabetes mellitus.
- •2) Patients with uncontrollable hypertension.
- •3) Patients with uncontrollable autoimmune disease.
- •4) Patients with severe skin disorder other than ATL lesion.
- •5) Patients with anamnesis of myocardial infarction and congestive heart failure, and complication of unstable angina.
- •6) Patients with less than 50% of resting ejection fraction in echocardiography and nuclear medical scan.
- •7) Patients with active double cancer.
- •8) Patients with uncontrollable active infection.
- •9) Patients with central nervous infiltration.
- •10) Patients with HIV antibody positive or HBs antigen positive.
- •11) Patients with complication of mental disease or psychiatric symptom.
- •12) Patients with pregnancy or possibility of pregnancy and patients with nursing.
- •13) Patients judged by the investigator to be inappropriate for study participation.
研究者
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