NCT00251511终止2 期
A Phase II Trial of Trisenox Plus Thalomid as Treatment in Patients With Myelodysplastic Syndrome
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Primary Study Endpoint:
研究概览
简要总结
This is a Phase II, open-label, non-randomized study in patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS).
Each cycle of treatment will be 6 weeks in length. Patients will be evaluated every 6 weeks for response. Patients will be treated for a minimum of 12 weeks even in the absence of response. Following 12 weeks of treatment, patients will continue to receive study treatment until disease progression or unacceptable toxicity.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for the study, patients must fulfill all of the following criteria:
- •Patients must have signed an IRB-approved informed consent.
- •Patients with low, intermediate-1, intermediate-2, and high-risk MDS (defined by IPSS) with documented diagnosis of MDS (refractory anemia, refractory anemia with excess blasts, refractory anemia with ringed sideroblasts, refractory anemia with mixed lineage dysplasia, or chronic myelomonocytic leukemia).
- •Patients must have a documented history of all transfusions (pRBC and/or platelets) received in the 60-day period prior to their initial Trisenox treatment on this protocol.
- •Patients with ECOG Performance Status of 0 or 1 (see Appendix I).
- •Absolute QT interval below 460 msec in the presence of serum potassium and magnesium values within the normal range.
- •Patients must be >/= 18 years of age.
- •Patients must either be not of child bearing potential or have a negative serum pregnancy test within 24 hours prior to registration. Patients are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or they are postmenopausal for at least 24 months.
- •For patients of childbearing potential, patient has agreed to use 2 reliable forms of contraception simultaneously for at least 1 month before beginning Thalomid therapy, during Thalomid therapy, and for 1 month following discontinuation of Thalomid therapy.
- •Renal function: creatinine < 1.5 x institutional upper limit of normal (ULN), CTCAE Grade
- •Hepatic function: bilirubin </= 1.5 x ULN, CTCAE Grade
- •AST </= 2.5 x ULN, CTCAE Grade
- •Serum potassium >4.0mEq/dL and serum magnesium >1.8 mg/dL.
排除标准
- •Any of the following criteria will make the patient ineligible to participate in this study:
- •Patients who have received prior chemotherapy or prior therapy with either Trisenox or Thalomid.
- •Patients who have a history of hypersensitivity to arsenic or thalidomide or any of the components in these drugs.
- •Patients with a significant history of cardiac disease (i.e., uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction in the last 6 months).
- •Patients with a history of torsade de pointes.
- •Patients planning to receive any concurrent therapy to treat MDS during the study treatment period.
- •Patients with a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection.
- •Patients with a history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of these study drugs for MDS.
- •Any patient who is pregnant or lactating.
- •Any patient who is unable to comply with requirements of study.
- •Patients with peripheral neuropathy >grade 1.
结局指标
主要结局
Primary Study Endpoint:
Determine the response rate (by IWG criteria) of patients with low, intermediate-1, intermediate-2, or high-risk MDS (defined by IPSS) to biweekly Trisenox plus daily Thalomid
次要结局
- Determine the toxicities associated with a biweekly Trisenox plus daily Thalomid regimen, the event-free survival, and the overall survival.
- Secondary Study Endpoint(s):
研究者
研究点 (2)
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