EUCTR2014-001280-13-DE进行中（未招募）1 期
An Open-Label Extension Study to Evaluate the Long-Term Effects of ACE-536 for the Treatment of Anemia in Patients with Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) Previously Enrolled in Study A536-03
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 153
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
- •All patients must meet the following criteria:
- •1. Completion of the treatment period in the base study A536-03.
- •2. Females of child bearing potential (defined as sexually mature women who have not undergone hysterectomy or bilateral oophorectomy, or are not naturally postmenopausal = 24 consecutive months) must have negative urine or blood pregnancy test prior to enrollment and use adequate birth control methods (abstinence, oral contraceptives, barrier method with spermicide, or surgical sterilization) during study participation and for 12 weeks following the last dose of ACE-536. Males must agree to use a latex condom during any sexual contact with females of child-bearing potential while participating in the study and for 12 weeks following the last dose of ACE-536, even if he has undergone a successful vasectomy. Patients must be counseled concerning measures to be used to prevent pregnancy and potential toxicities prior to dosing with ACE-536.
- •3. Patient is able to adhere to the study visit schedule, understand and comply with all protocol requirements.
- •4. Patient understands and is able to provide written informed consent.
- •Patients with treatment interruption (defined as patients who complete their A536-03 EOS visit) must also meet the following criteria:
- •1. Documented diagnosis of idiopathic/de novo MDS or non-proliferative chronic myelomonocytic leukemia (CMML) according to the World Health Organization (WHO) criteria2 (white blood count [WBC] < 13,000/µL) that meets International Prognostic Scoring System (IPSS) classification (Appendix 2) of low or intermediate-1 risk disease as determined by microscopic and standard cytogenetic analyses of the bone marrow and peripheral complete blood count (CBC) obtained during screening;
- •2. Anemia defined as:
- •- Mean hemoglobin concentration < 10.0 g/dL of 2 measurements (one performed within one day prior to Cycle 1 Day 1 and the other performed 7-28 days prior to Cycle 1 Day 1), for NTD patients (defined as having received < 4 units of RBCs within 8 weeks prior to Cycle 1 Day 1), OR
- •- Transfusion Dependent (TD), defined as having received = 4 units of RBCs within 8 weeks prior to Cycle 1 Day 1.
- •3. Platelet count = 30 x 10^9/L.
- •4. ECOG performance status of 0, 1, or 2 (if related to anemia).
- •5. Adequate renal (creatinine = 2.0 x upper limit of normal [ULN]) and hepatic (total bilirubin < 2 x ULN and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN) function.
- •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 76
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 77
排除标准
- •1. Discontinuation/withdrawal from the base study A536-03 (due to patient request, patient unwillingness or inability to comply with the protocol, pregnancy, use of prohibited medication [e.g. azacitidine], medical reason or AE, disease progression, persistent increase in white blood cell count (WBC), presence of = 1% blasts in peripheral blood, hypersensitivity reaction to the study drug, at the discretion of the sponsor, or loss to follow-up) prior to completion of the treatment period.
- •2. Prior treatment with azacitidine (injectable or oral) or decitabine.
- •3. Treatment within 28 days prior to Cycle 1 Day 1 with:
- •- Granulocyte colony-stimulating factor (G-CSF) and granulocyte-macrophage colony stimulating factor (GM-CSF),
- •- Lenalidomide.
- •4. For patients with treatment interruption only: Iron chelation therapy if initiated within 56 days prior to Cycle 1 Day 1.
- •5. Treatment with another investigational drug (including sotatercept [ACE-011]) or device, or approved therapy for investigational use = 28 days prior to Cycle 1 Day 1, or if the half-life of the previous investigational product is known, within 5 times the half-life prior to Cycle 1 Day 1, whichever is longer.
- •6. Major surgery within 28 days prior to Cycle 1 Day 1. Patients must have completely recovered from any previous surgery prior to Cycle 1 Day 1.
- •7. Known positive for human immunodeficiency virus (HIV), active infectious hepatitis B (HBV) or active infectious hepatitis C (HCV).
- •8. Uncontrolled hypertension defined as systolic blood pressure (SBP) = 150 mm Hg or diastolic blood pressure (DBP) = 100 mm Hg.
- •9. Pregnant or lactating females.
- •10. History of severe allergic or anaphylactic reactions or hypersensitivity to recombinant proteins or excipients in the investigational drug.
- •11. Any other condition not specifically noted above which, in the judgment of the investigator, would preclude the patient from participating in the study.
研究者
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