Phase II Study of Oral Clofarabine in Myelodysplastic Syndrome (MDS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Participants With a Complete Remission (CR)
研究概览
简要总结
The goal of this clinical research study is to learn if clofarabine given by mouth on a weekly schedule can help to control MDS. The safety of clofarabine given by mouth will also be studied.
详细描述
Clofarabine is a new chemotherapy drug that is designed to interfere with the growth and development of cancer cells.
If you are found to be eligible, you will be randomly assigned (as in the roll of dice) to one of 2 treatment groups. Participants in Group 1 will take a lower dose of clofarabine than Participants in Group 2. You have an equal chance of being assigned to either of the 2 treatment groups. Neither you nor your study doctor can choose your assignment. Later (after the first 40 patients), the assignment will favor the better treatment arm until one arm is selected as the significantly better one, or until 80 patients are treated in total. When you have been assigned to a treatment group, you will receive clofarabine as tablets once a day for 5 days in a row. This will be repeated every 4-8 weeks. Each 4-8 week period is considered 1 cycle of treatment.
Original patients who are still on study (original patients who received or are still receiving 30 mg/m2) have already been reduced to lower doses on subsequent courses or had treatment discontinued/completed. These patients will be asked to sign a new informed consent document to be made aware of the new developments in this study.
Each dose of clofarabine should be taken with 4 ounces of water in the morning, on an empty stomach. You must not eat or drink anything besides water from midnight the night before you take the study drug until 1 hour after taking the morning dose. You should take clofarabine every morning at about the same time. If vomiting occurs within 15 minutes of taking clofarabine, the dose may be repeated. If vomiting occurs more than 15 minutes after taking clofarabine, the dose cannot be replaced or made up.
Coffee and other caffeinated liquids cannot be taken before dosing and for 1 hour after dosing.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with MDS and >/= 5% blasts or IPSS risk intermediate or high; patients with Chronic myelomonocytic leukemia (CMML).
- •No prior intensive chemotherapy or high-dose ara-C (>/= 1g/m2).
- •Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed.
- •Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
- •Hydroxyurea is permitted for control of counts prior to treatment.
- •Procrit, GCSF are allowed before therapy.
- •Performance 0-2 (ECOG). Adequate organ function including the following:Adequate liver function (bilirubin of < 2mg/dl), and renal function (creatinine < 2mg/dl), and SGPT (ALT) < 3 X ULN. Adequate cardiac functions (NYHA cardiac III-IV excluded).
- •Signed informed consent.
排除标准
- •Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- •Active and uncontrolled infections.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Prior clofarabine treatment.
研究组 & 干预措施
Oral Clofarabine
10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
干预措施: Clofarabine (Drug)
结局指标
主要结局
Participants With a Complete Remission (CR)
时间窗: After 3 courses of treatment, up to 24 weeks.
Complete Remission (CR): Normalization of the peripheral blood and bone marrow with \<5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 109/ L, and a platelet count \> 100 x 109/L). Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. Hematologic Improvement: meets all criteria for CR except for platelet recovery to \>100 x 109/L. Clinical Benefit: Platelets increase by 50% and to above 30 x 109/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 109/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by \> 50%; or monocytosis reduction by \> 50% if pretreatment \> 5 x 109/L.
次要结局
未报告次要终点