NCT00021749已完成1 期
Phase I-II Multicenter Study of Genasense (Bcl-2 Antisense Oligonucleotide) in Patients With Advanced Chronic Lymphocytic Leukemia
Genta Incorporated3 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2001年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
研究概览
简要总结
This non-randomized study will test the safety and effectiveness of Genasense in patients with CLL.
详细描述
This study is a two-part phase I-II study. Part 1 will determine the MTD of Genasense in patients with CLL. This dose will then be tested in a non-randomized, multi-center, Phase II sequential clinical trial of Genasense used alone for treatment of patients with advanced CLL.
Pharmacokinetics of Genasense and kinetics of Bcl-2 down regulation and re-expression in CLL cells will be followed in selected patients.
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
- •Must have received at least one chemotherapy regimen that included fludarabine
- •Measurable disease
- •At least 3 weeks since biological therapy or radiation therapy for chronic lymphocytic leukemia
- •No previous stem cell transplantation
- •At least 3 weeks since surgery
排除标准
- 未提供
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
2 期
ONC-392 and Pembrolizumab in Platinum Resistant Ovarian CancerHigh Grade Serous Adenocarcinoma of OvaryFallopian Tube CancerOvarian CancerPrimary Peritoneal CarcinomaNCT05446298OncoC4, Inc.58
已完成
2 期
Sequential Regimen of Bendamustine-Debulking Followed by CAL-101 and GA101-Induction and -Maintenance in CLL (CLL2-BCG)Chronic Lymphocytic LeucemiaNCT02445131German CLL Study Group48
已完成
2 期
Sequential Regimen of Bendamustine-Debulking Followed by ABT-199 and GA101-Induction and -Maintenance in CLL (CLL2-BAG)Chronic Lymphocytic LeucemiaNCT02401503German CLL Study Group66
终止
2 期
Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic ImpairmentAdvanced Melanoma and Normal or ImpairedHepatic FunctionNCT00543205Genta Incorporated6
已完成
1 期
Safety and Tolerability Open Label Dose Escalation Study of Acadesine in B-CLL PatientsLeukemia, B-Cell, ChronicNCT00559624Advancell - Advanced In Vitro Cell Technologies, S.A.40