JPRN-jRCT2080223188已完成2 期
Phase 2/3 Study of AMG531 in Subjects with Aplastic Anemia Refractory to or Ineligible for Immunosuppressive Therapy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
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
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Diagnosis of AA confirmed by peripheral blood and bone-marrow examinations, etc.
- •2) Refractory to at least one course of immunosuppressive therapy including horse or rabbit anti-human thymocyte immunoglobulin (ATG); or ineligible for ATG treatment and refractory to cyclosporin (CyA)
- •3) Thrombocytopenia defined as a PLT of =< 30 X 10^9/L
- •4) Preserving main organ function as a result of screening as follows;
- •- Total bilirubin: < 1.5 times the upper limit of the laboratory normal range
- •- Alanine aminotransferase: < 3.0 times the upper limit of the laboratory normal range
- •- Aspartate aminotransferase: < 3.0 times the upper limit of the laboratory normal range
- •- Creatinine value:=< 2.0 mg/dL
- •5) An Eastern Cooperative Oncology Group performance status score of 0 to 2 at screening
- •6) >= 20 years of age at the time of obtaining informed consent
- •7) Patients who have provided written informed consent of their free will to participate in this study
排除标准
- •1) Concurrent active infection not adequately responding to appropriate therapy
- •2) Bone marrow reticulin grade of >= 2 based on the grading scale for reticulin indicated in Bone Marrow Pathology (2nd edition)
- •3) Proportion of blasts in bone marrow > 2%
- •4) Previous or concurrent active malignancies, other than localized tumors diagnosed more than one year previously and treated surgically with curative intent (basal cell carcinoma; or surgically resected in situ carcinoma of the cervix with an apparent success of >= 12 months prior to enrollment; as well as other cancers which have not been treated and remained disease-free for at least 5 years before enrollment are eligible)
- •5) Clinically significant cardiac disease (class III or IV of the New York Heart Association classification; unstable angina pectoris; myocardial infarction within 6 months before enrollment; cardiac disease accompanied by angioplasty or stenting within 6 months before
- •enrollment; or clinically significant cardiac arrhythmias) or uncontrollable hypertension 6) Arterial or venous thrombosis within one year before enrollment
- •7) Positive for anti-human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C virus-RNA at screening
- •8) Thrombocytopenia due to any other cause (e.g., MDS, idiopathic thrombocytopenic purpura, or liver cirrhosis)
- •9) Patients with AML or chronic myelomonocytic leukemia
- •10) Concurrent occurrence of hemolytic predominant paroxysmal nocturnal hemoglobinuria Hemolytic predominant is defined as lactate dehydrogenase > 1.5 times the upper limit of the laboratory normal range.
- •11) Uncontrolled diabetes mellitus
- •12) Receiving other investigational products within 16 weeks before AMG531 treatment initiation
- •13) Receiving any agent to treat AA, including the following agents before AMG531 treatment initiation;
- •- ATG treatment within 6 months before AMG531 treatment initiation
- •- CyA or anabolic steroid treatment within 6 weeks before AMG531 treatment initiation:
- •However, the patients who are treated with a CyA or anabolic steroid for at least 6 months before AMG531 treatment initiation may be enrolled if their blood cell count are stable at screening, and their dosage and administration will be kept for 6 weeks before AMG531 treatment initiation and during AMG531 dosing period.
- •14) A history of polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor, recombinant human TPO, AMG531, or other TPO-receptor agonists
- •15) Having a plan to undergo hematopoietic stem cell transplantation within 1 year
- •16) Having hypersensitivity to any recombinant protein E. coli derivative protein
- •17) Lactating or pregnant women or women of child-bearing potential who have no intention of using oral contraceptives or birth control
- •18) Having abnormalities by the cytogenetic test in bone marrow cells
- •19) Patients who are considered to be ineligible for the study by the investigator or subinvestigator for reasons other than above
研究者
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