NL-OMON54824招募中3 期
Treatment of chemo-refractory viral infections after allogeneic stem cell transplantation with multispecific T cells against CMV, EBV and AdV: A phase III, prospective, multicentre clinical trial - TRACE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 99（—）
入选标准
- •1. Adult or paediatric patients (>2 months of age) after HSCT suffering from
- •new or reactivated CMV or EBV or AdV infection, refractory to standard
- •antiviral treatment for two weeks (defined as <=1 log decrease in viral load
- •over two weeks) as confirmed by quantitative blood PCR analysis
- •2. Original HSCT-donor available with an immune response at least to the virus
- •causing the therapy-refractory infection
- •3. Written informed consent given (patient or legal representative)
排除标准
- •1. Acute GvHD > grade II or extensive chronic GvHD at time of T-cell transfer
- •2. Treatment with steroids (>1 mg/kg Prednisone equivalent) at Screening
- •3. Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP
- •infusion until 8 weeks post IMP infusion. In case of T-cell depleted HSCT, a
- •prescheduled prophylactic DLI <=3 x 10e5 T cells/kg BW is not considered an
- •exclusion criteria.
- •4. Organ dysfunction or failure as determined by Karnofsky (age >16 years) or
- •Lansky (age <=16 years) score <=30%
- •5. Concomitant enrolment in another clinical trial interfering with the
- •endpoints of this study
- •6. Any medical condition which could compromise participation in the study
- •according to the investigator*s assessment
- •7. Progression of underlying disease (disease that has led to the indication of
- •HSCT, e.g. leukemia) that will limit the life expectance below the duration of
- •8. Second line or experimental antiviral treatment other than
- •Ganciclovir/Valganciclovir, Foscarnet, Cidofovir and Rituximab from Screening
- •until 8 weeks after IMP infusion
- •9. Known HIV infection. In case patients do not have a negative HIV test
- •performed within 6 months before enrolment in the study, HIV negativity has to
- •be confirmed by a negative laboratory test.
- •10. Female patient who is pregnant or breast-feeding, or adult of reproductive
- •potential not willing to use an effective method of birth control from
- •Screening until the last follow-up visit (FU6, visit 8) Note: women of
- •childbearing potential must have a negative serum pregnancy test at study entry
- •11. Known hypersensitivity to iron dextran
- •12. Patients unwilling or unable to comply with the protocol or unable to give
- •informed consent.
研究者
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