EUCTR2009-011513-24-BE进行中（未招募）1 期
A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO COMPARE THE EFFICACY AND SAFETY OF LENALIDOMIDE (REVLIMID®) VERSUS PLACEBO IN SUBJECTS WITH TRANSFUSION-DEPENDENT ANEMIA DUE TO IPSS LOW OR INTERMEDIATE-1 RISK MYELODYSPLASTIC SYNDROMESWITHOUT DELETION 5Q[31] AND UNRESPONSIVE OR REFRACTORY TO ERYTHROPOIESISSTIMULATING AGENTS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 228
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.Must understand and voluntarily sign an informed consent form.
- •2.Age = 18 years at the time of signing the informed consent form.
- •3.Must be able to adhere to the study visit schedule and other protocol
- •requirements including willingness to undergo bone marrow aspirate
- •and biopsy as indicated in the study protocol.
- •4.Must be able to complete patient-reported outcome assessments either
- •independently or with minimal assistance from trained clinic personnel
- •or caregiver.
- •classification (Brunning, 2008) associated with the following features:
- •- IPSS low or intermediate-1 risk (subjects who were once a higher risk
- •IPSS are excluded)
- •- Any karyotype except del 5q [31] (at least 20 analyzable metaphases
- •are required for standard G-banding cytogenetic analysis at screening).
- •6.Must have transfusion-dependent anemia that meets the following
- •- Average transfusion requirement of =2 units‡/28 days of pRBCs
- •confirmed for a minimum of 112 days immediately preceding
- •randomization.
- •- No consecutive 56 days that was RBC transfusion-free during the 112
- •days immediately preceding randomization.
- •- Hemoglobin levels at the time of or within 7 days prior to transfusions
- •must have been = 9.0 g/dL¶ for the transfusions to qualify as required
- •for the purpose of providing evidence of transfusion-dependent anemia
- •7.Must be unresponsive or refractory to erythropoiesis-stimulating
- •agents, based on one of the following two criteria:
- •- Transfusion-dependence in subjects previously treated with an ESA
- •(requires a minimum ESA trial of > 40,000 U/week r-HuEPO x 8 weeks
- •or equivalent dose of darbepoetin or other erythropoietin agent), or
- •- Serum erythropoietin level of > 500 mU/mL in subjects not previously
- •treated with an ESA.
- •8.Must have an Eastern Cooperative Oncology Group (ECOG)
- •performance status score of 0, 1 or 2.
- •9.Concurrent corticosteroids used for medical conditions other than MDS
- •is allowed provided subject is on a stable or decreasing dose for = 1
- •week prior to randomization.
- •10.Females of childbearing potential (FCBP) must undergo pregnancy
- •testing based on the frequency outlined in Appendices 21.2 and 21.4 and
- •pregnancy results must be negative.
- •11.Unless practicing complete abstinence from heterosexual intercourse,
- •sexually active FCPB must agree to use adequate contraceptive methods
- •as specified in Appendices 21.2 and 21.4.
- •12.Males (including those who have had a vasectomy) must use barrier
- •contraception (condoms) when engaging in sexual activity with FCBP as
- •specified Appendices 21.2 and 21.4.
- •13.Males must agree not to donate semen or sperm during the duration
- •specified in Appendices 21.2 and 21.4.
- •14. All subjects must:
- •- Understand that the investigational product could have a potential
- •teratogenic risk.
- •- Agree to abstain from donating blood while taking investigational
- •product and following discontinuation of investigational product (see
- 另有 12 项未显示
排除标准
- •1.Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •2.Pregnant or lactating females.
- •3.Prior history of malignancies, other than MDS, unless the subject has been free of the disease for = 5 years. However, subjects with the following
- •history/concurrent conditions are allowed:
- •- Basal cell carcinoma of the skin
- •- Carcinoma in situ of the cervix
- •- Incidental histologic finding of prostate cancer (Tumor, Node
- •Metastasis (TNM) stage of T1a or T1b)
- •4. Known Human Immunodeficiency Virus (HIV), active Hepatitis B
- •Virus (HBV) and/or Hepatitis C Virus (HCV) infection.
- •5. Prior therapy with immunomodulating or immunosuppressive agents,
- •or epigenetic or DNA modulating agents. Subjects who received
- •investigational agents are also excluded.
- •6. Any of the following laboratory abnormalities:
- •- Absolute neutrophil count (ANC) < 500/µL (0.5 x 109/L)
- •- Platelet count < 50,000/µL (50 x 109/L)
- •- Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic
- •transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate
- •pyruvate transaminase (SGPT) > 3.0 x upper limit of normal (ULN) o
- •serum bilirubin levels > 1.5 x ULN; serum bilirubin levels > 1.5 x ULN
- •are acceptable if these can be attributed to ineffective erythropoiesis.
- •Subjects with ineffective erythropoiesis may have a decreased
- •haptoglobin level, elevated indirect bilirubin level and/or lactate
- •dehydrogenase level (refer to Appendix 21.10). Autoimmune hemolytic
- •anemia is an exclusion criterion.
- •7. Renal insufficiency (CrCl < 40 mL/min by Cockroft-Gault method)
- •8. Uncontrolled hyperthyroidism or hypothyroidism.
- •9. = Grade-2 neuropathy.
- •10. Use of an erythropoiesis stimulating agent within the 56 days prior
- •to randomization.
- •11. Prior allogeneic or autologous stem cell transplantation.
- •12. Concurrent use of androgens other than to treat hypogonadism.
- •13. Clinically significant anemia due to iron, B12, or folate deficiencies,
- •or autoimmune or hereditary hemolytic anemia, or gastrointestinal
- •*If marrow stain for iron is not available, the transferrin saturation
- •(iron/total iron binding capacity Fe/TIBC) must be >20% or serum
- •ferritin must be >100 ng/dL
- •14. Prior history of deep venous thrombosis (DVT) or pulmonary
- •embolus (PE) within 3
- •years of randomization.
- •15. Significant active cardiac disease within the previous 6 months
- •- New York Heart Association class II-IV congestive heart failure
- •- Unstable angina or angina requiring surgical or medical intervention
- •- Myocardial infarction
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