NCT00780052已完成1 期
Infusional C-myb Antisense Oligodeoxynucleotide in Advanced Hematological Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN
研究概览
简要总结
The purpose of this study is to evaluate whether C-myb Antisense (AS) Oligonucleotides (ODNs)is a possible treatment modality for advanced hematologic malignancies.
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 must have one of the following: acute myeloid or lymphoid leukemia; or Myeloproliferative disorder(MPD) including Chronic Myelogenous Leukemia (CML); or Myelodysplastic Syndrome (MDS); or Non-Hodgkin's Lymphoma (including CLL); or Multiple Myeloma
- •Patients with acute leukemia must meet one of the following conditions:
- •*have disease which is refractory to a course of standard induction chemotherapy *have relapsed diseased after documentation of previous clinical remission or *have untreated disease and not be a candidate for conventional first line treatment
- •Patients with CML or other MPD must have evidence of accelerated phase or blast crisis
- •Patients having clinical features of CML in transformation but who are negative for Philadelphia chromosome may be entered provided there is a prior definable chronic phase
- •Patients with Philadelphia chromosome positive CML must have failed treated with Gleevec (Imatinib) in order to be eligible for study
- •Patients with myelodysplastic syndrome (MDS) must have > 5% blasts in the peripheral blood or bone marrow and have at diagnosis as IPSS score of >= 1
- •Patients with CLL must have relapsed or refractory disease after at least three courses of conventional therapy and have been determined to no longer be a candidate for conventional therapy
- •Patients with non-Hodgkin's lymphoma (other than CLL) must have relapsed or refractory disease after at least two courses of chemotherapy and have been determined not to be a candidate for further conventional therapies
- •Patients with multiple myeloma must have failed at least 3 prior therapies
- •Performance Status 0, 1 or 2
- •Serum creatinine < 2.0 mg/dl; serum bilirubin < 2 mg/dl and AST/ALT < 3.0 x upper limit of normal
- •PTT within normal range
- •Age > 18
- •Patients must have an indwelling central venous catheter
排除标准
- •Significant cardiac disease which requires active therapy
- •Intercurrent organ damage or medical problems that will jeopardize outcome of therapy
- •Pregnant or lactating females
- •Received prior c-myb AS ODN therapy
- •Patients with suitable HLA identical sibling donor who are deemed to be appropriate and willing candidates for allogeneic bone marrow transplantation
- •Patients requiring anticoagulation with unfractionated heparin.
研究组 & 干预措施
1
Experimental
c-myb AS ODN as a 24-hour continuous infusion over 7 days
干预措施: c-myb AS ODN (Drug)
结局指标
主要结局
Dose-limiting toxicities and maximum tolerated dose and maximum tolerated duration of c-myb AS ODN
时间窗: At study completion
次要结局
未报告次要终点
研究者
研究点 (1)
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