jRCT2071240003招募中不适用
A phase I/II study of OJP-001 for recurrent or relapsed adult T-cell leukemia/lymphoma patients with peripheral blood tumor.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 49
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Hematocytologically or pathohistologically proven adult T-cell leukemia/lymphoma with positivity of anti-HTLV-1 antibody (Aggressive subtypes: acute, lymphoma type, or chronic type with unfavorable factor)
- •Age: 20-85
- •Meeting the any following criteria for screening
- •Relapsed or recurrent ATL have history of treatment with mogamulizumab
- •At least one regimen of chemotherapy in case of intolerance/contraindication for mogamulizumab
- •Having peripheral blood lesion
- •ECOG performance status: 0-2
- •T-Bil: =< ULNx2, AST and ALT: =< ULNx2.5
- •Expected more than 3 months of survival
排除标准
- •Body Weight < 35kg
- •Hemoglobin < 10g/dL
- •Splenomegaly
- •Subjects who received an following therapy
- •Chemotherapy or molecular-targeted agent for ATL : within 28 days prior to registration
- •Radiotherapy : within 28 days prior to registration
- •Any investigational drugs or medical devices (unapproved in Japan) : within 28 days prior to registration
- •Autologous stem cell transplantation : within 84 days prior to registration
- •Allogenic stem cell transplantation : within 100 days prior to registration
- •Administrated 5-ALA drug except study drug within 7 days prior to registration
- •Ate the foods containing 5-ALA or St. John's wort within 7 days prior to registration
- •Synchronous or metachronous malignancy
- •Uncontrolled severe complications
- •Porphyria
- •Uncontrolled cardiac arrhythmia or Chronic congestive heart failure (NYHA Class III or IV)
- •Uncontrolled inter-current illness including: heart failure, kidney failure, liver failure, hypertension, diabetes mellitus
- •Psychological disorder (mental illness, dementia, depression)
- •HBs-Ag positive or HBc-Ab positive with HBV-DNA positive
- •HCV-Ab positive
- •HIV-Ab positive
- •CNS involvement at screening
- •QTcF > 470ms at screening
- •Uncontrolled intercurrent infection
- •Pregnant or nursing women
- •During participated in other clinical trials
- •Other inadequate conditions determined by investigators
- •In phase II part: subjects who registrated in phase I part of this trial
结局指标
主要结局
-
Phase I part: dose limiting toxicity Phase II part: response rate (best overall response)
次要结局
未报告次要终点
研究者
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