Allogeneic Transplantation After a Conditioning With Thiotepa, Busulfan and Fludarabin for the Treatment of Refractory/Early Relapsed Aggressive B-cell Non Hodgkin Lymphomas: a Phase II Multi-Center Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 42
- 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 progression free survival, transplant-related morbidity (TRM) at day +100 and at +365, overall survival and incidence of acute and chronic GVHD in refractory/early relapsed aggressive B-cell non Hodgkin lymphomas patients treated with allogeneic Transplantation after a conditioning with Thiotepa, Busulfan and fludarabin.
详细描述
In the present study, it is hypothesised that patients with aggressive B cell lymphomas refractory to or relapsed early (within 12 months) after the completion of standard first-line immunoProtocol TBF2012 Version 1, 20 Nov 2012 9 chemotherapy can benefit from de-bulking salvage therapy (i.e. R-DHAP + bortezomib) followed by an allograft to improve progression-free survival.
Patient inclusion criteria
- Patients with refractory/relapsed aggressive B-cell non Hodgkin lymphomas after frontline therapy.
- Patients with stable disease or partial or complete remission (PET-negative) after salvage therapy
- Patients younger than 65 years old
- A fully HLA-identical sibling or matched unrelated donor is available. Patients with one antigen mismatched donors can be considered
- Patient must be competent to give consent
Patient exclusion criteria
- Patients treated with an autologous transplant as salvage therapy
- Patients with progressive lymphomas despite conventional therapies
- Patients with progressive lymphomas despite conventional therapies
- Uncontrolled CNS involvement with disease
- Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
- Females who are pregnant or breastfeeding
- Organ dysfunction defined as follows:
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1
- Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg)
- Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg)
- Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2)
干预措施: Thiotepa (Drug)
1
- Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg)
- Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg)
- Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2)
干预措施: Busulfan (Drug)
1
- Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg)
- Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg)
- Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2)
干预措施: Fludarabin (Drug)
1
- Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg)
- Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg)
- Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2)
干预措施: transplant (HCT) (Procedure)
1
- Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg)
- Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg)
- Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2)
干预措施: Cytoreduction (Radiation)
1
- Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg)
- Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg)
- Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2)
干预措施: Immunosuppression (Drug)
1
- Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg)
- Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg)
- Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2)
干预措施: Cyclosporine (Drug)
1
- Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg)
- Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg)
- Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2)
干预措施: Methotrexate (Drug)
1
- Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg)
- Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg)
- Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2)
干预措施: ATG (Drug)
1
- Thiotepa 5 mg/kg/day on days -7, -6 (Total Dose 10 mg/kg)
- Busulfan (i.v.) 3.2 mg/kg on days -5,-4,-3 (Total Dose 9.6 mg/kg)
- Fludarabin: 50 mg/m2/day on days -5,-4,-3 (Total Dose 150 mg/m2)
干预措施: Collection and infusions of Donor PBSC (Procedure)
结局指标
主要结局
Progression free survival
时间窗: 2 years
次要结局
- Incidence of acute and chronic GVHD(2 years)
- Transplant-related morbidity (TRM) at day +100 and at +365(1 year)
- Overall survival(2 years)
研究者
Benedetto Bruno
MD
Azienda Ospedaliera San Giovanni Battista