A Pilot Study to Assess the Feasibility of Unrelated Umbilical Cord Blood Transplantation With Coinfusion of Third-party Mesenchymal Stem Cells After Myeloablative or Nonmyeloablative Conditioning in Patients With Hematological Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- treatment-related mortality
研究概览
简要总结
A pilot study to assess the feasibility of unrelated umbilical cord blood transplantation with coinfusion of third-party mesenchymal stem cells after myeloablative or nonmyeloablative conditioning in patients with hematological malignancies.
This is a multicenter single arm, phase I-II pilot study. The primary objective of this study is to determine the feasibility of Umbilical Cord Blood (UCB) Hematopoietic Stem Cell Transplantation (HSCT) with co-infusion of third party mesenchymal stem cells as assessed by the treatment-related mortality at d100 after transplant.
Patient inclusion criteria:
Age 15-60 yrs, Patients for whom allogeneic stem cell transplantation is the preferred treatment option, with the following hematological malignancies: acute myeloid leukemia, acute lymphoblastic leukemia, high risk myelodysplastic syndrome, advanced lymphoproliferative disorders, chronic myeloid leukemia (refractory or intolerant to second-line tyrosine kinase inhibitors), multiple myeloma, Informed consent given, Patient exclusion criteria, Previous allogeneic transplant, Progressive malignant disease, Significant organ damage as a contraindication to allotransplantation, Significant psychiatric or neurological disorder, Uncontrolled viral, fungal or bacterial infection, Pregnancy, HIV positive, Patients will receive either myeloablative or reduced intensity conditioning. One or 2 cord blood transplants will be transplanted, followed by infusion of a third-party mesenchymal stem cell transplant, Adverse event reporting Belgian Hematology Society (BHS) transplant committee will establish a protocol review committee which will organize a central monitoring of the study. Within the context of allogeneic Hematopoietic Stem Cell Transplantation (HSCTx) many severe events are likely to occur.
Statistics and stopping rules: The trial will be stopped at any time that there is reasonable evidence that the true rate of day +100 nonrelapse mortality exceeds 0.40. It is the intention to include an initial 20 patients.
详细描述
PROTOCOL SYNOPSIS
Title of the study A pilot study to assess the feasibility of unrelated umbilical cord blood transplantation with coinfusion of third-party mesenchymal stem cells after myeloablative or nonmyeloablative conditioning in patients with hematological malignancies.
Design of the study This is a multicenter single arm, phase I-II pilot study.
Primary objective The primary objective of this study is to determine the feasibility of UCB HSCT with co-infusion of third party mesenchymal stem cells as assessed by the treatment-related mortality at d100 after transplant.
Secondary objectives
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
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Allogeneic stem cell transplantation is the preferred treatment option:
- •High risk acute myeloid leukemia (AML) in first complete remission (CR)
- •Preceding myelodysplastic syndrome
- •High risk karyotypes (e.g. monosomy 5 or 7, complex)
- •FLT3 alteration
- •> 2 cycles to obtain CR
- •Erythroblastic or megakaryocytic leukemia
- •High risk acute lymphoblastic leukemia (ALL) in first CR
- •High risk karyotypes (e.g. t[9;22], t[4;11], t[1;19], complex)
- •MLL rearrangements
- •Acute leukemia in second or third remission
- •High risk myelodysplastic syndrome: IPSS Intermediate-2 or high risk
- •Advanced lymphoproliferative disorders
- •Diffuse large B-cel non-Hodgkin lymphoma (NHL) or mantle cell NHL or
- •B-prolymphocytic leukemia
- •Sensitive relapse after autologous HSCTx
- •T-prolymphocytic leukemia
- •Chronic lymphocytic leukemia
- •Refractory to fludarabine
- •Adverse karyotypes (del p17)
- •Chronic myeloid leukemia
- •Refractory or intolerant to second-line tyrosine kinase inhibitors
- •Multiple myeloma
- •Advanced disease (selected cases)
- •Informed consent given
排除标准
- •Previous allogeneic transplant
- •Progressive malignant disease
- •Significant organ damage as a contraindication to allotransplantation
- •Creatinine clearance < 60 ml/min
- •AST/ALT > 3x normal value and/or serum bilirubin > 3 mg/dL
- •Cardiac failure (LVEF < 50%)
- •Clinical relevant pulmonary disease: DLCO < 50% normal
- •Significant psychiatric or neurological disorder
- •Uncontrolled viral, fungal or bacterial infection
- •Pregnancy
- •HIV positive
结局指标
主要结局
treatment-related mortality
时间窗: day 100 after transplant
death related to treatment procedures
次要结局
- Hematopoietic recovery(One year after transplant)