EUCTR2021-002073-26-DE进行中（未招募）1 期
Phase 1/2 Trial to determine the safety and efficacy of Extracorporeal photopheresis as treatment for steroid-refractory immune related adverse events after immune checkpoint inhibitor therapy - ECIR (ECP for irAE)
Medical Center - University of Freiburg0 个研究点目标入组 30 人开始时间: 2022年2月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
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.Male and female patients aged =18 years with adequate German written and oral language skills
- •2.Written informed consent:
- •Subjects must have signed and dated an IRB/IEC approved written informed consent form in accordance with regulatory and institutional guidelines.
- •Subjects must be able to understand and willing to comply with scheduled visits, treatment schedule, laboratory tests and mandatory collection of blood, and other requirements of the study.
- •Subject Re-enrollment: This trial permits the re-enrollment of a subject that has discontinued the study as a screening failure. If re-enrolled, the subject must be re-consented.
- •3.Target population
- •Patients who have received treatment with an anti-PD-1, anti-PD-L1 or an anti-CTLA-4 antibody or any combination of these for any type of malignancy in the last 24 months before screening. 30% of the patients that will be included should have non-skin cancer.
- •Patients should have clinical and/or histological evidence of immune-related adverse events as follows:
- •?Diarrhea with increase of =4 stools over baseline
- •?No improvement after 72h treatment with at least 1 mg/kg BW/day prednisolone equivalent
- •ooHepatitis
- •?Alanine aminotransferase and/or aspartate aminotransferase =3x ULN if baseline was normal; or =3x baseline if baseline was abnormal and/or total bilirubin >1.5 ULN.
- •?No improvement after 72h treatment with at least 1 mg/kg BW/day prednisolone equivalent
- •oPneumonitis
- •?Radiographic changes that involve more than one lobe of the lung or =25% of lung parenchyma and new symptoms such as cough, dyspnea or chest painor new oxygen therapy
- •?No improvement after 72h treatment with 1 mg/kg BW/day prednisolone equivalent
- •oDermatitis
- •?Skin erythema, maculopapular or pustulopapular rRash covering >=30% of the body surface area and moderate or severe symptoms
- •?No improvement after 72h treatment with at least 1 mg/kg BW/day prednisolone equivalent
- •4.Maximum of one additional (second line) therapy after Steroid treatment before ECP starts (e.g. infliximab for colitis)
- •5.Women of childbearing potential (WOCBP) must have a negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 1 week prior to the start of study drug. Males who are sexually active with WOCBP must use during the duration of the study and up to 5 months afterwards a latex or synthetic condom during any sexual contact with females of reproductive potential, even if they have undergone a successful vasectomy (see also 10.9). Patients must abstain from donating blood, semen, or sperm during participation in the study
- •6.Women must not be breastfeeding.
- •7.ECOG performance status 0, 1, or 2
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1.Active treatment in a clinical study of any investigational agent within 14 days prior day 0 or within 5 half-lives of the study treatment, whichever is greater.
- •2.Positive result for HIV.
- •3.Active COVID-19-infection or non-compliance with the prevailing hygiene measures regarding the COVID-19 pandemic
- •4.Prior allogeneic bone marrow transplantation or prior solid organ transplantation.
- •5.Patients who require vasopressors, and/or have NYHA class III or IV heart failure.
- •6.Uncontrolled hypertension or ventricular arrhythmias.
- •7.Previous or concurrent malignancies within the last 3 years of enrollment other than the disease for which checkpoint-inhibitor blockade was applied. Exceptions are adequately treated basal or squamous cell skin cancer, or any other cancer from which the subject has been disease-free for more than 3 years.
- •8.Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the subject; or interfere with interpretation of study data
- •9.Known allergies, hypersensitivity, or intolerance of methoxypsoralen, excipients, or similar compounds, acid-citrate-dextrose or similar compounds
- •10.Aphakia
- •11.Sexually active men and female patients of child-bearing potential who are not willing to use highly effective methods of contraception during the trial and at least 5 months after the last ECP procedure (see also 10.9
- •12.Inability to tolerate extracorporeal volume loss
- •13.Previous splenectomy
- •14.Pregnancy and lactation
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