A Phase I/II Study of OJP-001 for Recurrent or Relapsed Adult T-cell Leukemia/Lymphoma Patients With Peripheral Blood Tumor.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 49
- 试验地点
- 7
- 主要终点
- Phase I part: Dose limiting toxicity
研究概览
简要总结
This study aims to evaluate the tolerability of OJP-001, a therapeutic system combining photodynamic therapy (PDT) using OMD-001 and extracorporeal circulation therapy using OJE-001 and OJC-001, in patients with adult T-cell leukemia/lymphoma (ATL). The study will also investigate the recommended dose and pharmacokinetics of OMD-001, as well as the efficacy and safety of OJP-001.
详细描述
[Phase I part] Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive OJP-001 once.
Dosage of 5-ALA: 10 mg/kg (1st cohort), 20 mg/kg (2nd cohort), 40 mg/kg (3rd cohort), 60 mg/kg (4th cohort)
[Phase II part] Patients will receive 5-ALA and OJP-001 once a week for 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •Relapsed or recurrent ATL judged inadequate of treatment with mogamulizumab by investigators
- •Relapsed or recurrent ATL after allogeneic hematopoietic stem cell transplantation
- •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
研究组 & 干预措施
OJP-001 Group
Patients will receive 5-ALA administered orally once. After administration of 5-ALA, patients will receive OJP-001 once.
干预措施: Drug:5-ALA, Device:Photodynamic system (Other)
结局指标
主要结局
Phase I part: Dose limiting toxicity
时间窗: Phase I part: 2 weeks
Phase II part: Response rate (best overall response)
时间窗: Phase II part: 24 weeks
次要结局
未报告次要终点