A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim-sndz,Gemtuzumab Ozogamicin and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Toxicity rate
研究概览
简要总结
This phase II trial studies the side effects and how well fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride work in treating patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Drugs used in chemotherapy, such as fludarabine phosphate, cytarabine, and idarubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to a antitumor drug, called calicheamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers calicheamicin to kill them. Colony-stimulating factors, such as filgrastim-sndz, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving fludarabine phosphate, cytarabine, filgrastim-sndz, gemtuzumab ozogamicin, and idarubicin hydrochloride may kill more cancer cells.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the safety of a regimen incorporating fludarabine phosphate (fludarabine), high-dose cytarabine, filgrastim-sndz, gemtuzumab ozogamicin and idarubicin hydrochloride (idarubicin) in patients with untreated inv(16) or t(8;21) acute myeloid leukemia (AML).
II. Evaluate the complete remission rates achieved in this population with this regimen.
SECONDARY OBJECTIVES:
I. Assess the proportion of patients with untreated inv(16) or t(8;21) AML who, having entered complete remission (CR) on this regimen, remain alive in CR two years from CR date.
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
- •Patients must have untreated AML, or high-risk myelodysplastic syndromes (MDS) (refractory anemia with excess blasts, [RAEB], or RAEB "in transformation" [RAEB-t]) characterized by t(8;21), inv(16), or t(16;16); the presence of additional abnormalities is irrelevant
- •Patients must provide written consent
- •Participants will not be excluded based on performance status; for patients with Eastern Cooperative Oncology Group (ECOG) performance status >= to 3 the dosing schedule will be discussed with study chairman
- •Patients with organ dysfunction will not be excluded from the study; for patients with evidence of organ dysfunction (creatinine >= 1.5, cardiac ejection fraction =< 50%, total bilirubin >=2 and aspartate aminotransferase [AST]/alanine aminotransferase [ALT] >= 3 times upper limit of normal [ULN]), dose adjustments/omissions will be made
- •Up to one cycle of prior induction therapy will be permitted to include patients in whom presence of "good-risk" cytogenetics was initially missed; if the patient is in remission from induction therapy, he/she will receive post-remission therapy; if the patient is not in remission then he/she will receive induction therapy
- •Patients of child bearing potential should practice effective methods of contraception
排除标准
- •Pregnant and lactating females will be excluded
研究组 & 干预措施
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
See Detailed Description
干预措施: Cytarabine (Drug)
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
See Detailed Description
干预措施: Decitabine (Drug)
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
See Detailed Description
干预措施: Filgrastim-sndz (Biological)
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
See Detailed Description
干预措施: Fludarabine Phosphate (Drug)
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
See Detailed Description
干预措施: Gemtuzumab Ozogamicin (Drug)
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
See Detailed Description
干预措施: Idarubicin (Drug)
Treatment (filgrastim, fludara, cytara, gemtuzu, idarubicin)
See Detailed Description
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Toxicity rate
时间窗: Up to 2 years
Complete remission rate
时间窗: Up to 2 years
次要结局
未报告次要终点