NCT00575068已完成1 期
A Phase I/II Trial of Anti-CD80 Monoclonal Antibody (IDEC-114) Therapy for Patients With Relapsed or Refractory Follicular Lymphoma
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
- Biogen
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- To characterize the safety profile of IDEC-114 and to define their duration and reversibility
研究概览
简要总结
The purpose of this study is to determine whether anti-CD80 monoclonal antibody (IDEC-114) is effective in the treatment of follicular B-cell non-Hodgkin's lymphoma. This drug has never been studied in patients with lymphoma, however, it has been studied in psoriasis patients at various dose levels and schedules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically confirmed follicular lymphoma that has relapsed or has failed primary therapy
- •Progressive disease requiring further treatment
- •Bidimensionally measurable disease
- •Acceptable hematologic status
- •Prestudy WHO performance status of 0, 1, or 2
- •Expected survival of >/= 3 months
- •Patients with reproductive potential must follow accepted birth control methods during treatment and for 3 months after completion of treatment
- •Female patients must not be pregnant or lactating
- •Recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, ABMT, or investigational drugs
排除标准
- •Cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks of first scheduled treatment (6 weeks if nitrosourea or mitomycin-C)
- •Prednisone or other immunosuppressive therapy within 3 weeks of first scheduled treatment
- •Prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to first scheduled treatment
- •Previous exposure to IDEC-114 or any anti-CD80 antibody
- •ABMT within 6 months prior to first scheduled treatment
- •Abnormal liver function
- •Abnormal renal function
- •Presence of chronic lymphocytic leukemia (CLL)
- •Presence of CNS lymphoma
- •Presence of HIV infection or AIDS
- •Prior diagnosis of aggressive non-Hodgkin's lymphoma or mantle-cell lymphoma
- •Another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable PSA) for which the patient has not been disease-free for at least 3 years
- •Serious nonmalignant disease which would compromise protocol objectives in the opinion of the investigator and/or the sponsor
- •New York Heart Association Class III or IV cardiac disease or myocardial infarction within 6 months prior to first scheduled treatment
- •Major surgery, other than diagnostic surgery, within 4 weeks prior to first scheduled treatment
- •Pleural invasion and/or effusion with positive cytology for lymphoma
- •Peritoneal invasion and/or ascites with positive cytology for lymphoma
研究组 & 干预措施
1
Experimental
干预措施: IDEC-114 (Drug)
结局指标
主要结局
To characterize the safety profile of IDEC-114 and to define their duration and reversibility
时间窗: March 2010
次要结局
- To evaluate efficacy(March 2010)
- To evaluate PK(March 2010)
- To monitor presence of human anti galiximab antibody(March 2010)
- To identify Nk functional assays that may predict galiximab efficacy(March 2010)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety and Efficacy of IDEC-114 in Combination With Rituxan in the Treatment of Non-Hodgkin's LymphomaNon-Hodgkin's LymphomaNCT00048555Biogen90
进行中（未招募）
2 期
Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung CancerPancreatic Ductal AdenocarcinomaRefractory Non-Small Cell Lung CancerNCT06015724Georgetown University19
终止
2 期
Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Total Body Irradiation, and Donor Stem Cell Transplant Followed by Cyclosporine and Mycophenolate Mofetil in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic SyndromeAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Childhood Myelodysplastic SyndromesPreviously Treated Myelodysplastic SyndromesRecurrent Adult Acute Myeloid LeukemiaRecurrent Childhood Acute Myeloid LeukemiaRefractory Anemia With Excess BlastsRefractory Anemia With Excess Blasts in TransformationRefractory Anemia With Ringed SideroblastsChronic Myelomonocytic LeukemiaRefractory Cytopenia With Multilineage DysplasiaSecondary Acute Myeloid LeukemiaSecondary Myelodysplastic SyndromesNCT00119366Fred Hutchinson Cancer Center18
撤回
1 期
Safety Study of Anti-Programmed Death-Ligand 1 in Hematologic MalignancyNon-Hodgkin's LymphomaMultiple MyelomaHodgkin LymphomaChronic Myelogenous LeukemiaNCT01452334Bristol-Myers Squibb
终止
2 期
"Prime Boost" Vaccination Strategy Combining Conjugated Anti- Pneumococcal Vaccine (s0) and Polysaccharide Anti- Pneumococcal Vaccine (s4) Compared to Polysaccharide Anti- Pneumococcal Vaccine Alone (s4) In Patients With Common Variable ImmunodeficiencyCommon Variable ImmunodeficiencyNCT01489618Institut National de la Santé Et de la Recherche Médicale, France45