EUCTR2017-002194-18-DE进行中（未招募）1 期
Phase 1/2 Trial to determine the Response Rate of Nivolumab in Acute Myeloid Leukemia (AML) relapse after Allogeneic Hematopoietic Cell Transplantation (allo-HCT)
Medical Center - University of Freiburg0 个研究点目标入组 20 人开始时间: 2018年1月10日最近更新:
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
- 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
入选标准
- •1.Relapse of AML after allo-HCT from any donor source (matched unrelated donor, mismatched unrelated donor, sibling, haploidentical) using bone marrow or peripheral blood stem cells at 3 months or more after allogeneic HCT. Patients can be rescreened.
- •2. Cytological or histological evidence of AML relapse including but not limited to bone marrow biopsy, extramedullary site biopsy or cerebrospinal fluid evaluation.
- •3.No immune suppression for at least 2 weeks prior to screening
- •4.10% or more donor-derived chimerism measured within 4 weeks prior to day 0
- •5.Male and female patients aged =18 years
- •6.ECOG performance status 0, 1, or 2
- •7.No other superior treatment approach (second allo-HCT) available
- •8.At least 1 cycle of therapy with the hypomethylating agents decitabine or azacitidine between diagnosis of relapse and screening
- •9.Written informed consent
- •10.Ability to understand the nature, significance and consequences of the study and the study-related procedures and to comply with them.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.History or active acute GvHD grade III/IV
- •2.Chronic GvHD requiring systemic immunosuppressive treatment at the time of screening
- •3.Active autoimmune diseases
- •4.Active treatment in a clinical study of any investigational agent within 30 days prior day 0 or within 5 half-lives of the study treatment, whichever is greater
- •5.Mechanical ventilation or patients who have resting O2 saturation <90% by pulse-oximetry, require vasopressors, and/or have NYHA class III or IV heart failure
- •6.Abnormal liver function tests (serum total bilirubin 1,5 x ULN; or in case of liver infiltration by AML, serum (total) bilirubin > 5 x ULN, serum alanine or aspartate aminotransferase >3 × ULN or in case of liver infiltration by AML, AST and/or ALT > 5 x ULN)
- •7.Abnormal kidney function tests (calculated creatinine clearance =30 ml/min by the Cockcroft-Gault equation)
- •8.Severe hematological impairment (platelets <10 000/µl, hemoglobin level <8 mg/dl unless attributable to AML infiltration of the BM), there is no lower limit for neutrophil counts because AML relapse leads to low neutrophil numbers and treatment with nivolumab could improve this by eradicating the leukemia
- •9.Active uncontrolled bacterial, viral or fungal infection
- •10.Positivity for HIV, Hepatitis B or Hepatitis C at the time of screening
- •11.Active or latent tuberculosis infection that has developed after allo-HCT
- •12.Previous or concurrent malignancies within the last 3 years of enrolment except for adequately treated basal cell or squamous cell skin cancer, or any other cancer from which the subject has been disease-free for more than 3 years
- •13.Uncontrolled hypertension or ventricular arrhythmias
- •14.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
- •15.Known allergies, hypersensitivity, or intolerance of the study medication, excipients, or similar compounds
- •16.Female patients who are pregnant or breast feeding
- •17.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 dose of nivolumab (see also 10.9)
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