NCT05066412招募中1 期
A Phase I Clinical Trial Assessing Prophylactic Donor CD45RA-depleted Lymphocyte Infusions Into Patients Transplanted with Stem Cell Grafts from Haploidentical Donors After Reduced Intensity Conditioning
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- acute transfusion reaction (CTCAE ≥ 2)
研究概览
简要总结
To assess safety of prophylactic escaladed dose of T naïve depleted (CD45RA depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.
详细描述
Primary Objective is to determine whether the administration of prophylactic CD45RAneg (CD45RAneg) memory/effector T lymphocytes is feasible and safe in the early post-transplant period for patients with haploidentical transplant and RIC conditioning.
Donor lymphocytes are isolated from the original donor by non-mobilized mononuclear cell leukapheresis. Repetitive intravenous infusions (up to 3) of escalating doses of CD45RAneg cells, prepared from the leukapheresis by CliniMACS® technology (CD45RA-depletion), storage in vapor nitrogen.
Escalating doses of CD45RAneg cells, for patients with haploidentical graft, intervals of 6-8 weeks, if GvHD is absent starting ≥ 4 weeks from the day of 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received a stem cell graft from a haploidentical donor after RIC for hematologic malignancies
- •Written informed consent of patient and donor obtained
排除标准
- •Participant taking Prednisone (or equivalent steroid)
- •Participant taking Prednisone (or equivalent steroid)
- •Participant taking Mycophenolate Mofetil
- •Participant taking Cyclosporine/tacrolimus at therapeutic blood levels
- •Progressive hematologic malignancy before transplant
- •Second allogeneic transplant
- •Acute GvHD ≥ grade 2
- •Chronic moderate or severe GvHD (NIH consensus criteria)
- •Hematologic or molecular relapse of the primary malignancy requiring chemotherapy or unmanipulated DLI (receiving prophylactic antileukemic agent, eg TKI, is not an exclusion criteria)
- •Donor aberrant CD45RA expression due to a polymorphism in CD45 gene
- •Participation in another interventional clinical trial within 30 days prior to inclusion
- •Pregnant or nursing women. Sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective method of contraception during participation in the study from time of inclusion until 2 months after last dose of CD45RAneg DLI infusion
- •Inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia
结局指标
主要结局
acute transfusion reaction (CTCAE ≥ 2)
时间窗: 24 hours after each CD45RA neg DLI infusion
acute transfusion reaction after each DLI infusion (CTCAE ≥ 2)
acute GvHD grade II-IV
时间窗: within 8 weeks after each CD45RAneg DLI infusion
acute GvHD grade II-IV measured with MAGIC score
次要结局
未报告次要终点
研究者
Anne-Claire Mamez
Principal Investigator
University Hospital, Geneva
研究点 (2)
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