NCT00724009已完成2 期
Clofarabine Bone Marrow Cytoreduction : Feasibility of Induction as a Bridge to Allogeneic Stem Cell Transplantation for Patients With Relapsed or Refractory Acute Leukemias, Myelodysplastic Syndromes, and Advanced Myeloproliferative Diseases.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Cytoreductive Response
研究概览
简要总结
For relapsed and refractory leukemia patients induction chemotherapy prior to initiating a conditioning regimen will decrease residual leukemia (as measured by bone marrow leukemia blast percentage) at the time of HCT. This should lead to reduced relapse while still maintaining low transplant related mortality.
详细描述
Screening will be done prior to enrollment in the study. The following will be done as part of the screening process:
- Medical history review
- Physical exam
- Measurement of vital Signs
- Blood tests (approximately 6 teaspoons of blood) will be done to see if the liver and kidneys are healthy, HIV (the virus that causes AIDS) test for this study and pregnancy test.
- Urine test
- Bone marrow biopsy and aspirate
If the patient is ineligible or does not have a donor for Allogeneic Stem Cell transplantation, you will not be able to participate in this clinical trial.
After results of these tests are obtained, your doctor will decide whether you can participate in this study.
Study procedures:
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
- •Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
- •Adequate hepatobiliary function as indicated by the following laboratory values:
- •SGOT/SGPT <=2.5 x upper limit of normal
- •Alkaline phosphatase <=2.5 x upper limit of normal
- •Serum bilirubin < 1.5 mg/dl
- •Adequate renal function as indicated by the following laboratory values:
- •Creatinine Clearance >50 ml/min
- •Age >/=18 years
- •Zebroid performance status </= 2 (See Appendix A)
- •Life expectancy is not severely limited by concomitant illness (i.e. < 3months life expectancy from non-leukemic conditions).
- •No evidence of chronic active hepatitis or cirrhosis.
- •HIV-negative
- •Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
- •Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment.
排除标准
- •Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol.
- •Use of investigational agents within 30 days or any anticancer therapy within 2 weeks before study entry with the exception of hydroxyurea. The patient must have recovered from all acute non-hematologic toxicities from any previous .
- •Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment.
- •Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
- •Pregnant or lactating patients.
- •Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results.
研究组 & 干预措施
Clofarabine
Experimental
Clofarabine 30 mg/m2/day IV infusion over one hour for 5 consecutive days
干预措施: Clofarabine (Drug)
结局指标
主要结局
Cytoreductive Response
时间窗: Day 12
Percent of patients achieving cytoreductive response of marrow cellularity \<20% and blasts \< 10%
次要结局
- Number of Participants With Cardiac Adverse Events(Day 12)
- Number of Participants With Renal Adverse Events(Day 12)
- Number of Participants With Hepatic (Total Bilirubin) Adverse Events(Day 12)
- Number of Participants With Hepatic (SGOT) Adverse Events(Day 12)
- Number of Participants With Skin Adverse Events(Day 12)
- Number of Participants Infection Adverse Events(Day 12)
- Leukemia Free Survival(2 years)
研究者
研究点 (1)
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