Prospective Phase II Clinical Trial of Myeloablative Conditioning Regimen With Fludarabine and Busulfan Plus 400 cGy Total Body Irradiation for Hematologic Malignancies
试验速览
- 阶段
- 2 期
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
The purpose of this study is to evaluate the OS, RFS, and TRM after HCT with low-dose total body irradiation, fludarabine, and busulfan conditioning.
详细描述
Conventional allogeneic hematopoietic cell transplantation (HCT) for patients with hematological malignancies involves conditioning with high doses of systemic chemo/radiation therapy such as cyclophosphamide (CY) plus 1200 or 1000 cGy total body irradiation (TBI; CY/TBI) or busulfan (Bu) / CY (BuCy). Unfortunately, such regimens have been associated with significant toxicities, limiting their use to otherwise healthy, relatively young patients.
Recently, Fludarabine plus 4 day dose of busulfan (FluBu4) containing myeloablative regimen has been introduced successfully without increasing transplant-related mortality (TRM). To improve transplant outcomes without increasing the risk of recurrence, Russell et al introduced 400cGy of TBI with antithymocyte (ATG, 4.5mg/Kg) into FluBu4 regimen with successful outcomes.
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
- •At least 15 years old and not more than 65 years old.
- •ECOG performance status 0-
- •Patients with AML or MDS with intermediate/unfavorable cytogenetics.
- •Patients with ALL and CML ineligible for Cy/TBI conditioning.
- •Patients with NHL or HD eligible to myeloablative HCT.
- •Patients receiving unrelated BMT for AML, MDS, ALL, CML, NHL or HD.
- •Consent form signed and dated prior to study specific procedures.
- •Subject able to comply with the scheduled follow-up and with the management of toxicities.
排除标准
- 未提供
研究组 & 干预措施
Regimen
Conditioning regimen for AML with FLT3 mutation, AML/MDS unfavorable cytogenetic risk group, chemorefractory NHL or HD, or ALL/CML
干预措施: fludarabine phosphate, busulfan (Drug)
结局指标
主要结局
progression free survival
时间窗: one year
次要结局
- relapse of primary disease, overall survival, and occurrence of acute/chronic GVHD(one year)