Therapy of Myelodysplastic Syndrome (MDS) With Azacitidine Given in Combination With Etanercept: A Phase I/II Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
研究概览
简要总结
This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may protect normal cells from the side effects of chemotherapy
详细描述
PRIMARY OBJECTIVES:
I. Determine the frequency of hematologic responses in patients with MDS to 5-aza (azacitidine) plus etanercept.
II. Determine the efficacy of 5-aza combined with etanercept in patients with low or intermediate (int)-1 risk who fail to respond to anti-thymocyte globulin (ATG) plus etanercept and for the purpose of this trial are considered as having progressive or "more advanced" disease.
III. Correlate results of ex vivo/in vitro studies on phenotypic, cytogenetic and functional disease characteristics with in vivo treatment responses, to identify parameters that are associated with a high probability of response.
OUTLINE:
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
- •Int-2 or high risk MDS patients
- •Patients with low-risk or int-1 risk MDS by International Prognostic Scoring System (IPSS) criteria with:
- •Single or multilineage cytopenia (absolute neutrophil count [ANC] < 1500/μL, hemoglobin [Hgb],10g/dL, or platelet count < 100,000/μL); or
- •Transfusion requirement of at least 2 units of packed red blood cells over an 8 week period
- •Serum creatinine =< 1.5x ULN (upper limit of normal)
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2x ULN
- •Performance status =< 2 (Eastern Cooperative Oncology Group [ECOG] scale, 0-5)
排除标准
- •Patients who have previously received hematopoietic stem cell transplants, specifically for MDS
- •Patients with a diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) criteria (i.e >= 20% blasts) at time of enrollment
- •Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
- •Men who are unwilling to use contraception while receiving 5-aza
- •Patients with severe disease other than MDS which is expected to prevent compliance with the present protocol
- •Patients with severe infections (pneumonia, septicemia, etc) within the 2 weeks prior to the anticipated start of protocol treatment
- •Patients who are currently receiving or within the preceding 2 weeks have received cytotoxic therapy, hemopoietic growth factors, immunomodulatory therapy, or other experimental therapy for the treatment of MDS
- •Current evidence of uncontrolled cardiac arrhythmia or congestive heart failure
- •Platelet count =< 10,000/mcl
- •Absolute neutrophil count =< 250/mcl
- •Prior treatment with 5-aza
- •Known or suspected hypersensitivity to azacitidine or mannitol
研究组 & 干预措施
Treatment (chemotherapy, chemoprotection)
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: etanercept (Biological)
Treatment (chemotherapy, chemoprotection)
Patients receive etanercept SC twice weekly during weeks 1 and 2 and azacitidine SC or IV over 10-40 minutes on days 1-7. Treatment repeats every 28 days for at least 3 courses. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: azacitidine (Drug)
结局指标
主要结局
Frequency of Hematologic Responses, as Defined by International Working Group (IWG) Criteria
时间窗: Up to 2 years
Count of participants with a hematologic improvement (erythroid, platelet, or neutrophil response), assessed at 3 months.
次要结局
未报告次要终点
研究者
Bart Scott
Principal Investigator
Fred Hutchinson Cancer Center