NCT00401739已完成1 期
Phase I Study of CSL360 in Patients With Relapsed, Refractory or High-Risk Acute Myeloid Leukemia
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
- CSL Limited
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Adverse events, pharmacokinetics
研究概览
简要总结
Acute myeloid leukemia (AML) is a heterogeneous group of diseases characterized by uncontrolled proliferation of the myeloid line of white blood cells and impaired production of normal blood cells. If untreated, patients die of infection or bleeding usually in a matter of weeks. CSL360 is a neutralising monoclonal antibody which is believed to target the cells that are thought to drive AML but that are not effectively killed by standard treatment. The aims of the study are to determine a biologically active dose of CSL360 and generate understanding of a rational schedule of administration for future studies.
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
- •Clinical diagnosis of acute myeloid leukemia
- •Recent bone marrow biopsy
- •Prior treatment or medically unfit for standard therapy
排除标准
- •Peripheral blood blast count > 30 x 109/L, or rapidly progressive AML
- •Previous solid organ transplant
- •Active GvHD or immunosuppression
- •Concurrent treatment with other anti-cancer therapy
- •Active infections
研究组 & 干预措施
I
Experimental
Treatment with CSL360
干预措施: CSL360 (Drug)
结局指标
主要结局
Adverse events, pharmacokinetics
时间窗: September 2009
次要结局
- Maximum tolerated dose(September 2009)
- Partial, complete and overall response(September 2009)
- Biological activity(September 2009)
研究者
研究点 (6)
Loading locations...
相似试验
终止
不适用
CAR-T Cells Therapy in Relapsed/Refractory Acute Myeloid LeukemiaRelapsed/Refractory Acute Myeloid Leukemia(AML)NCT03473457Zhujiang Hospital2
招募中
2 期
Addition of sulfalasazine to chemotherapy for the treatment of AML in the elderly2024-513084-38-00Assistance Publique Hopitaux De Paris64
进行中（未招募）
2 期
Efficacy of HAD Induction With Intensified Cytarabine in Newly-diagnosed CEBPA Double Mutated Acute Myeloid LeukemiaCEBPA Double MutationAcute Myeloid LeukemiaNCT04415008Institute of Hematology & Blood Diseases Hospital, China61
Unknown
2 期
A Phase 2 Study of Venetoclax in Combination With Low-dose HHT, G-CSF, and AZA as First-line Treatment for Newly Diagnosed Elderly AML Patients Unfit for Intensive ChemotherapyLeukemia, Myeloid, AcuteNCT04824924Shanghai Jiao Tong University School of Medicine100
已完成
1 期
A Phase 1 Dose Escalation and Expanded Cohort Study of EPZ-5676 in the Treatment of Pediatric Patients With Relapsed/Refractory Leukemias Bearing a Rearrangement of the MLL GeneAcute Lymphocytic LeukemiaAcute LeukemiasLeukemiaAcute Myeloid LeukemiaNCT02141828Epizyme, Inc.18