Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- CIR, DFS
研究概览
简要总结
Evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1).
详细描述
5.2 AUTOLOGOUS PBSCS HARVESTING
5.2.1. PBSCs will be collected during recovery phase after the second cycle of HDAC consolidation chemotherapy.
5.2.2. For mobilization, recombinant human granulocyte- colony-stimulating factor (G-CSF, Filgrastim) will be given subcutaneously at a dose of 10 mcg/kg from day 9 of the 2nd HDAC cycle until the completion of harvesting.
5.2.3. PBSCs harvesting will be performed via perm-cath or Quinton catheter, which will be inserted with fluoroscopy-guided before starting and will be removed after finishing harvest.
5.2.4. Harvest will be initiated from the day when the peripheral absolute neutrophil count reach up to 0.2 x 109/mm3. Peripheral blood mononuclear cells will be collected by leukapheresis method with 'CS-3000' (Baxter, Deerfield, IL) or other compatible machine. Cell collection will be performed for at least 2 days and the duration of collection can be extended until a target CD34+ cell dose of 5 x 106/kg (in terms of body weight of recipient) is collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CBF positive AML in CR
- •CBF AML includes t(8;21)(q22;q22) [AML1(RUNX1)/ETO(CBFα2T1)], inv(16)(q13q22) (CBFβ/MYH11),t(16;16)(p13;q22) (CBFβ/MYH11) Using RT-PCR, FISH, or standard karyotype analysis technique.
- •Patients who plan to receive the second cycle of HDAC consolidation chemotherapy.
- •15 years old or older and 65 years or younger
- •Adequate performance status (Karnofsky score of 70 or more).
- •Adequate hepatic and renal function (AST, ALT, and bilirubin < 3.0 x upper normal limit, and creatinine < 2.0 mg/dL).
- •Adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiography)
- •Signed and dated informed consent must be obtained from patient.
排除标准
- •Presence of significant active infection
- •Presence of uncontrolled bleeding
- •Any coexisting major illness or organ failure
- •Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
- •Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
- •Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
结局指标
主要结局
CIR, DFS
时间窗: 6 years
* Relapse incidence (cumulative incidence of relapse, CIR) * Disease-free survival (DFS)
次要结局
- TRM, EFS, OS(6 years)