Prophylactic Infusion of Donor Lymphocytes in Cord Blood Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- Safety assessment
研究概览
简要总结
Pilot, multicentric, open-label, single-arm, phase I-II clinical trial to evaluate the safety and efficacy of a novel Umbilical Cord Blood Transplantation (UCBT) platform, that consists of a UCBT of the 80 fraction, followed by a Donor Lymphocyte Infusion (DLI) of the 20 fraction (between 60 and 90 days after transplantation).
详细描述
Multicenter, open-label, single-arm, phase I-II pilot study in which a minimum of 20 patients will enter the study with the primary objective to assess the safety and secondary objective to assess efficacy in relation to immune reconstitution followed by a new platform of treatment consisting of initial cord blood unit 80 fraction transplantation, followed by a prophylactic donor lymphocyte infusion (DLI) of the fraction 20 of the cord blood unit. The second infusion will take place between 60 and 90 days after transplantation.
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
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of transplantation:
- •Patients under 60 years with proposal UCBT according to assistance protocol
- •Diagnosis of high-risk acute leukemia with an indication of allogenic transplantation
- •Frozen UCB bag split into two bags: one with the 80% of the product and another with the 20%
- •Presence of at least 1.2E9 total nucleated cells and> 1E5 CD34 / kg and> 6E6 CD34 + in fraction 80%
- •4/6 or better compatibility taking Human Leukocyte Antigen (HLA) HLA-A, HLA-B by antigenic resolution and DRB1 by allelic resolution
- •The patient (or legal representative if required) has signed the informed consent
- •At the time of DLI:
- •Documented cord blood engraftment
- •The patient has had no Graft Versus Host Disease (GVHD) during the first 60 days post-transplantation or, if present, receives less than 10 milligrams of prednisone at the time of the DLI or <0.2 mg / kg / day of prednisone for pediatric patients (<16 years).
- •The patient has less than 200 CD4 + cells per microliter on peripheral blood at 60 days (± 7 days) post-transplantation
- •The patient (or legal representative if required) has signed the informed consent
排除标准
- •At the time of transplantation:
- •Simultaneous participation in another clinical trial or treatment with other research phase product within 30 days prior to inclusion in the study.
- •Pregnant women or those who intend to become pregnant within 12 months after the signing of the informed consent or not taking proper contraceptive measures according to investigator criteria.
- •Breastfeeding women
- •Other pathologies or circumstances that may compromise the patient's participation in the study according to the criteria of the investigator.
- •At the time of DLI:
- •Grade III-IV GVHD after allogeneic UCB
- •Prednisone treatment (> 10 mg total per day in adults or> 0.2 mg / kg / day prednisone for pediatric patients)
研究组 & 干预措施
Experimental
DLI of the 20 fraction of the UCBT
干预措施: DLI of the 20 fraction of the UCBT (Drug)
结局指标
主要结局
Safety assessment
时间窗: 1 year
Adverse events
次要结局
- Mortality(1 year)
- Immune reconstitution:(1 year)
- Infections in treated patients(1 year)
- Survival curves(1 year)
- Immune regeneration(1 year)
- Immunological reconstitution:(1 year)
- Relapse of leukemia(1 year)
- Infections in the treated patients(1 year)