NCT00251368已完成1 期
Multicenter Study of 9-AC in Refractory Leukemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- To evaluate the toxicity and maximum tolerated dose of 9-AC administered as a 72 hour infusion in patients with relapsed/refractory leukemia.
研究概览
简要总结
The purpose of this study is to evaluate the side effects of 9-Aminocamptothecin (9-AC) and to determine the best dose which should be used to treat leukemia.
详细描述
- The treatment patients will receive involves a continuous infusion of 9-AC intravenously for a 72 hour period. Since we are unsure of the safest and most effective dose, successive groups of 4-7 patients will receive larger doses of this drug until the largest dose given safely is established.
- Prior to the start of therapy a bone marrow aspirate and biopsy will be taken for diagnostic and research purposes. A bone marrow exam will be repeated at 48 hours in order to determine the effects of 9-AC on leukemic cells in the bone marrow. A bone marrow scan will also be performed 14 days after the start of therapy to assess response.
- Frequent blood testing will be done throughout treatment, including blood samples to determine the levels of the 9-AC in the blood.
- Treatment could be stopped prematurely if any of the following occur: 1) drug causes severe side effects, 2) the drug does not control the leukemia, or 3) the doctors or the patient feel that it is no longer in the patients best interest to receive this therapy.
- Approximately 7 days after the conclusion of the 9-AC infusion, it is likely that the patient's blood counts will be low and will require support with antibiotics, red cell transfusions and platelet transfusions.
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
- •18 years of age or older
- •AML or ALL in first or subsequent relapse, secondary AML, or CML in blastic phase
- •Central venous access
- •ECOG performance status of less than or equal to 2
- •Bilirubin < 1.3
- •SGOT < 2 x ULN
- •Alkaline phosphatase < 2 x ULN
- •Creatinine < 1.5
排除标准
- •Undergone bone marrow transplantation
- •Uncontrolled infection
- •Other active malignancy
- •HIV positivity
- •Serious medical or psychiatric illness
- •Pregnancy
结局指标
主要结局
To evaluate the toxicity and maximum tolerated dose of 9-AC administered as a 72 hour infusion in patients with relapsed/refractory leukemia.
时间窗: Years
次要结局
- To analyze the pharmacokinetics in these patients.(years)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
Aminocamptothecin in Treating Patients With Refractory or Recurrent Hodgkin's Disease or Non-Hodgkin's LymphomaLymphomaNCT00002745National Cancer Institute (NCI)37
进行中（未招募）
1 期
A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)Myasthenia GravisMultiple SclerosisNCT06220201Juno Therapeutics, Inc., a Bristol-Myers Squibb Company120
暂停
1 期
A Clinical Study to Explore the Safety and Efficacy of CT0991 in Relapsed/Refractory Acute Myeloid LeukemiaRelapsed/Refractory Acute Myeloid Leukemia(AML)NCT06709131He Huang24
Unknown
不适用
Conventional and Experimental Chemotherapy With Allogeneic Transplant in Young Patients With Acute Myeloid LeukaemiaAcute Myeloid LeukemiaNCT01785953Azienda Ospedaliera San Giovanni Battista300
终止
3 期
Treatment of Childhood Acute Lymphoblastic LeukemiaAcute Lymphoblastic LeukemiaNCT00165087Dana-Farber Cancer Institute491