EUCTR2018-000911-25-ES进行中（未招募）1 期
A prospective multicenter open, not controlled phase Ib-II clinical trial to assess the safety and immunologic efficacy of virus-specific T lymphocytes from the best donor in receptors of hematopoietic progenitor allogeneic transplant
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Recipient of an allogeneic hematopoietic progenitors cell transplant (irrespectively of the donor source, donor type conditioning and underlying disease) that is beyond the day +30 of the procedure
- •2. Patient with post-transplant infection due to CMV refractory or resistant to optimal pharmacological treatment. Specifically, the patient must be included in any of the following cases
- •a) Patient with organic disease caused by CMV (confirmed by histology) resistant to antiviral first line treatment
- •b) Patient with CMV reactivation and no organic disease, resistant or intolerant to 2 previous antiviral treatment lines (ganciclovir/valganciclovir and foscarnet) or not candidate to be treated due to not acceptable expected toxicity (severe renal insufficiency, neutropenia or severe thrombopenia)
- •It is agreed that the patient is affected with a resistant CMV infection if the CMV copies doesn’t decrease in > 1 log in total blood or otherwise the absolute number of copies > 1x10E4/mL in total blood after 2 weeks of antiviral treatment.
- •c) Patients with reactivation of recurrent CMV despite correct anti-CMV treatment.
- •It will be considered a recurrent CMV infection if the patient has> 2 reactivations in a period <6 months despite having received correct anti-CMV treatment
- •d) Documented genetic mutations associated with ganciclovir or foscarnet resistance
- •3. = 1 year of age
- •4. Estimated life expectancy > 30 days
- •5. Signature of the informed consent form
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 9
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1.Acute GVHD = grade II or chronic = moderate
- •2.Corticosteroid = 0.5mg/kg regardless the indication
- •3.Disease relapse at the time of infection or at any time after the Allogeneic transplant.
- •4.Severe renal disease (creatinine > 3gr/dL)
- •5.Severe hepatic disease (bilirrubine >3mg/dL or AST >500 U/L) except if it is secondary to the viral infection.
- •6.Having received a donor lymphocytes infusion or any cell therapy product within 60 days prior to inclusion in the study (with the exception of transfusions), or having it planned within the next 60 days.
- •7.Alteration of the general condition, infection or clinical or hemodynamic instability that, in the opinion of the researcher, does not recommend the use of T cells
- •8.Known hypersensitivity to murine proteins or iron dextran.
- •9.Positive serology to HIV, HBV (HBsAg, HBcAc), HCV and/or syphilis
- •10.Pregnant, lactating or women without adequate contraception (*)
- •11.Participation in a clinical trial with investigational medicinal products the last 30 days
- •(*) The effective contraceptive methods contemplated in the protocol are the hormonal ones, intrauterine device (IUD), barrier methods, voluntary sterilization or females with menopause > 1 year of duration.
- •The criteria should be reviewed once the donor has been selected and before proceeding to the donor's lymphoapheresis to confirm that the patient is still a candidate for treatment.
研究者
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