A Randomized Study of Decitabine Alternating With Clofarabine Versus Decitabine Until Failure in Patients With Higher Risk Myelodysplastic Syndromes (MDS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Event Free Survival (EFS) at 1 Year
研究概览
简要总结
The goal of this clinical research study is to learn if sequential administration of decitabine and clofarabine can help to control MDS better than decitabine alone. The safety of this drug combination will also be studied.
详细描述
The Study Drugs:
Decitabine is designed to damage cells' DNA (genetic material), which may cause myelodysplastic marrow cells to work more like normal marrow cells.
Clofarabine is designed to interfere with the growth and development of abnormal marrow cells.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 with higher risk MDS (IPSS int-2 or high, or >/= 10% blasts as defined by WHO or FAB). - No prior intensive chemotherapy or high-dose cytarabine (>/= 1 g/m2). - Prior biologic therapies (</= 1 cycle of prior decitabine or azacitidine), targeted therapies, or single agent chemotherapy is allowed. - Off chemotherapy for 2 weeks prior to entering this study with no toxic effects of that therapy, unless there is evidence of rapidly progressive disease. - Hydroxyurea is permitted for control of counts prior to treatment. - Hematopoietic growth factors are allowed. .
- •Age >/= 18 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status </=
- •Have adequate renal function (serum creatinine </= 1.5 mg/dL)
- •Serum bilirubin </= 1.5 x upper limit of normal (ULN)
- •Aspartate transaminase (AST) or alanine transaminase (ALT) </= 2.5 x ULN
- •Alkaline phosphatase </= 2.5 x ULN
- •Provide signed written informed consent.
- •Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent.
- •Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment.
- •Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.
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 toxicities from any previous therapy.
- •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
- •Any concurrent malignancy (with the exception of exclusion # 8)
- •Exceptions to inclusion # 7: a) Patients with treated non-melanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; b) Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on prostate-specific antigen (PSA) values are also eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed.
研究组 & 干预措施
Decitabine + Clofarabine
Drug delivery intravenously (IV) in alternating series of cycles (Decitabine 20 mg/m^2 for 5 days first 3 cycles, then Clofarabine 10 mg/m^2 five days for next 3 cycles), pattern repeats for up to 24 cycles.
干预措施: Decitabine (Drug)
Decitabine + Clofarabine
Drug delivery intravenously (IV) in alternating series of cycles (Decitabine 20 mg/m^2 for 5 days first 3 cycles, then Clofarabine 10 mg/m^2 five days for next 3 cycles), pattern repeats for up to 24 cycles.
干预措施: Clofarabine (Drug)
Decitabine
Decitabine 20 mg/m^2 IV daily for 5 days for a total of 24 courses.
干预措施: Decitabine (Drug)
结局指标
主要结局
Event Free Survival (EFS) at 1 Year
时间窗: Assessed at 12 months/1 year
Percentage of participants with event free survival at 1 year. Event free survival (EFS) where event is defined as either death or transformation to acute myeloid leukemia (AML) (marrow and/or blood blasts \>/= 20%)
次要结局
- Participant Response(Up to 6 months)