A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids for Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Participants Complete Response
研究概览
简要总结
This phase II trial studies how well clofarabine, idarubicin, cytarabine, vincristine sulfate, and dexamethasone work in treating patients with mixed phenotype acute leukemia that is newly diagnosed or has returned after a period of improvement (relapsed). Drugs used in chemotherapy, such as clofarabine, idarubicin, cytarabine, vincristine sulfate, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the response rate of the chemotherapy regimen in patients with mixed phenotype acute leukemia.
SECONDARY OBJECTIVE:
I. To evaluate the durability of response, the overall and event-free survival rates, and the safety profile of the regimen.
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
- •Sign an informed consent document
- •Newly diagnosed or relapsed mixed phenotype acute leukemia (MPAL), which for this protocol, will be defined as follows: bone marrow result interpreted by the reading pathologist (or tissue biopsy for cases of extramedullary disease) as: biphenotypic leukemia, bilineal leukemia, undifferentiated leukemia, mixed lineage leukemia, leukemia of ambiguous lineage, T/myeloid leukemia, B/myeloid leukemia, or other diagnosis indicating the presence of multiple lineages within the cell population
- •Eastern Cooperative Oncology Group (ECOG) performance status of =< 3 at study entry
- •Adequate organ function as outlined below (unless due to leukemia)
- •Serum creatinine =< 3 mg/dL
- •Total bilirubin =< 2.5 mg/dL
- •Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) and/or aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) =< 3 x upper limit of normal (ULN) or =< 5 x ULN if related to disease
- •Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days; women of childbearing potential and men must agree to use contraception at study entry and for the duration of active study treatment
- •Cardiac ejection fraction >= 40% (by either cardiac echocardiogram [echo] or multi gated acquisition [MUGA] scan); documentation of recent (=< 6 months from screening) outside reports is acceptable
- •If newly diagnosed, prior therapy with hydrea and/or steroid and the use of a single or a two day dose of cytarabine (up to 3 g/m^2), for emergency use up to 24 hours prior to start of study therapy is allowed
排除标准
- •Breast feeding females
- •Patients with active, uncontrolled infections
- •Patients with active secondary malignancy will not be eligible unless approved by the principal investigator
研究组 & 干预措施
Treatment (combination chemotherapy)
See Detailed Description.
干预措施: Clofarabine (Drug)
Treatment (combination chemotherapy)
See Detailed Description.
干预措施: Cytarabine (Drug)
Treatment (combination chemotherapy)
See Detailed Description.
干预措施: Dexamethasone (Drug)
Treatment (combination chemotherapy)
See Detailed Description.
干预措施: Idarubicin (Drug)
Treatment (combination chemotherapy)
See Detailed Description.
干预措施: Rituximab (Biological)
Treatment (combination chemotherapy)
See Detailed Description.
干预措施: Sorafenib (Drug)
Treatment (combination chemotherapy)
See Detailed Description.
干预措施: Sorafenib Tosylate (Drug)
Treatment (combination chemotherapy)
See Detailed Description.
干预措施: Vincristine (Drug)
Treatment (combination chemotherapy)
See Detailed Description.
干预措施: Vincristine Sulfate (Drug)
结局指标
主要结局
Participants Complete Response
时间窗: Up to 2 months
Response is Complete Response (CR) is Neutrophil count \>/= 1.0 x 10\^9/L, . Platelet count \>/= 100 x 10\^9/L, Bone marrow aspirate \< 5% blasts, No extramedullary leukemia.
次要结局
- 4-week Mortality Rate(At 4 weeks)