NCT01768338已完成1 期
A Phase I Study of Recombinant Human Interleukin-18 (SB-485232) in Combination With Ofatumumab After Autologous Peripheral Blood Stem Cell Transplantation for Lymphoma
Michael John Robertson1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2013年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab
研究概览
简要总结
The purpose of this study is to test the safety of rhIL-18 combined with ofatumumab to see what effects (good and bad) it has on subjects and their non-Hodgkin's lymphoma.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have undergone high-dose therapy and autologous PBSCT for treatment of CD20+ lymphoma.
- •Patients must be between 2-6 months post-transplantation at the time of study registration.
- •Patients must have at least stable disease (no overt progressive disease) at the time of study registration.
- •Laboratory values must be within protocol specified ranges.
- •Females of childbearing potential must have a negative pregnancy test.
- •Females of childbearing potential and males must use an effective method of contraception from the time of consent until at least 365 days following discontinuation of protocol therapy.
排除标准
- •Patient must not have obvious clinical progression of lymphoma after PBSCT as determined by the treating physician.
- •Cannot be positive for hepatitis B surface antigen, hepatitis B core antibody or HIV antibody.
- •No major or uncontrolled comorbid conditions as determined by the treating physician: history of ventricular arrhythmias requiring drug or device therapy; uncontrolled angina or symptomatic congestive heart failure; • severe or uncontrolled infection requiring systemic antibiotic or antifungal therapy or active hepatitis C infection; severe or uncontrolled psychiatric illness.
- •No known leptomeningeal involvement by lymphoma or current metastatic brain disease.
- •No Corrected QTc interval > 480 msec.
- •No known or suspected hypersensitivity to ofatumumab or SB-485232 that in the opinion of the investigator is a contraindication to their participation in the study.
- •No systemic (oral or parenteral) corticosteroids within 14 days of study entry.
- •Not receiving concurrent chemotherapy, biologic therapy, radiotherapy, or other investigational therapy.
- •No previous treatment with SB-485232 or ofatumumab.
- •No history of other malignancy except for adequately treated non-invasive cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix.
- •No diabetes mellitus with poor glycemic control (documented hemoglobin A1c >7% within 4 weeks prior to study entry).
研究组 & 干预措施
Ofatumumab combined with SB-485232
Experimental
Otatumumab: 1000 mg IV for 4 weeks. SB-485232: escalating doses (3 ug/kg up to 30 ug/kg) for 8 weeks.
干预措施: Ofatumumab combined with SB-485232 (Drug)
结局指标
主要结局
To evaluate the the number of subjects with adverse events who receive SB-485232 when given in combination with ofatumumab
时间窗: 8 weeks
Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 which uses a scale of 1 (mild) to 5 (caused death).
次要结局
- To evaluate the biologic effects of SB-485232 given in combination with ofatumumab(8 weeks)
研究者
Michael John Robertson
Professor of Medicine
Indiana University
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Phase I Trial of Recombinant Human Interleukin-10 (SCH 52000) in Patients With Wegener's GranulomatosisWegener's GranulomatosisVasculitisNCT00001761National Institute of Allergy and Infectious Diseases (NIAID)15
已完成
1 期
2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/IIChronic Myelogenous Leukemia, BCR-ABL1 PositiveCord Blood Transplant RecipientMyeloproliferative NeoplasmAcute Myeloid LeukemiaMyelodysplastic SyndromeNCT03941769M.D. Anderson Cancer Center1
进行中（未招募）
1 期
Clinical Trial to Evaluate the Safety and Immunogenicity of Ferritin Nanoparticles Expressing Native-like HIV-1 Envelope Trimers Followed by Boost With mRNA Lipid Nanoparticles Encoding a Native-like HIV-1 Envelope Trimer in Adults Without HIVHivNCT05903339National Institute of Allergy and Infectious Diseases (NIAID)36
已完成
1 期
Humanized 3F8 Monoclonal Antibody (Hu3F8) When Combined With Interleukin-2 in Patients With High-Risk Neuroblastoma and GD2-positive Solid TumorsNeuroblastomaNCT01662804Memorial Sloan Kettering Cancer Center14
撤回
不适用
Recombinant Human Interleukin-11 Combination Low-dose Rituximab in Immune ThrombocytopeniaPurpura, Thrombocytopenic, IdiopathicNCT01317966Ming Hou