EUCTR2015-002874-19-CZ进行中（未招募）1 期
A Study to Evaluate Imetelstat (GRN163L) in Transfusion-Dependent Subjects with IPSS Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) that is Relapsed/Refractory to Erythropoiesis-Stimulating Agent (ESA) Treatment
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 170
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. Man or woman =18 years of age (or the legal age of consent in the jurisdiction the study is taking place);
- •2. Criterion modified per Amendment 1.
- •2.1. Criterion modified per Amendment 2.
- •2.2. Criterion modified per Amendment 3
- •2. 3 In Part 1, diagnosis of MDS according to WHO criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to C1D1. A local laboratory report from this diagnostic bone marrow aspirate and biopsy must be reviewed and approved by the sponsor (Attachment 1). In Part 2, diagnosis of MDS according to WHO criteria confirmed by bone marrow aspirate and biopsy within 12 weeks prior to Randomization (Attachment 1). A sample of the baseline bone marrow aspirate and biopsy must be submitted to the Independent Central Pathology Reviewer for diagnostic confirmation. Central laboratory review is required to confirm diagnosis prior to randomization.
- •3. IPSS low or intermediate-1 risk MDS (Attachment 3);
- •4. Criterion modified per Amendment 1.
- •4.1. RBC transfusion dependent, defined as requiring at least 4 RBC units transfused over an 8-week period during the 16 weeks prior to C1D1 (Part 1) or Randomization (Part 2) (defined in Section 3.1); pre-transfusion Hb should be =9.0 g/dL to count towards the 4 units total;
- •5. Has MDS that is relapsed/refractory to ESA treatment; as defined by meeting any one of the criteria below:
- •5.1. Received at least 8 weeks of treatment with a minimum weekly dose of epoetin alfa 40,000 U, epoetin beta 30,000 U or darbepoetin alfa 150 mcg (or equivalent agent/dose), without having achieved a Hb rise =1.5 g/dL or decreased RBC transfusion requirement by at least 4 units over 8 weeks
- •5.2. Transfusion dependence or reduction in Hb by =1.5 g/dL after hematologic improvement, in the absence of another explanation
- •5.3. Criterion 5.3 replaced by criterion 5.4 per Amendment 1.
- •5.4. Endogenous serum EPO level >500 mU/mL;...
- •More details see protocol
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1. Subject has known allergies, hypersensitivity, or intolerance to imetelstat or its excipients (refer to the IB 25 );
- •2. Subject has received an investigational drug or used an invasive investigational medical device within 30 days prior to C1D1 (Part 1) or Randomization (Part 2) (defined in Section 3.1) or is currently enrolled in an investigational study;
- •3. Prior treatment with imetelstat;
- •4. Criterion modified per Amendment 2. 4.1 Have received corticosteroids >30 mg/day prednisone or equivalent, or growth factor treatment within 4 weeks prior to C1D1 (Part 1) or Randomization (Part 2);
- •5. Criterion modified per Amendment 2. 5.1 Prior treatment with a hypomethylating agent (eg, azacitidine, decitabine); 5.2 Prior treatment with lenalidomide; 5.3 Has received an ESA or any chemotherapy, immunomodulatory, or immunosuppressive therapy within 4 weeks prior to C1D1 (Part 1) or Randomization (Part 2)(8 weeks for long-acting ESAs);
- •6. Prior history of hematopoietic stem cell transplant;
- •7. Anemia attributed to factors other than MDS (including hemolysis, chronic renal failure, hepatitis, gastrointestinal bleeding);
- •8. Major surgery within 4 weeks prior to C1D1 (Part 1) or Randomization (Part 2)(excluding the placement of vascular access and other minor surgical procedures);
- •9. Diagnosed or treated for malignancy other than MDS, except:
- •9.1. Malignancy treated with curative intent and with no known active disease present for =3 years before C1D1 (Part 1) or Randomization (Part 2)
- •9.2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
- •9.3. Adequately treated cervical carcinoma in situ without evidence of disease;
- •10. Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of C1D1 (Part 1) or Randomization (Part 2), or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification;
- •More details see protocol
研究者
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