EUCTR2005-000454-73-ES进行中（未招募）1 期
A multicenter, randomized, double-blind, placebo-controlled, 3-arm study of the efficacy and safety of 2 doses of lenalidomide versus placebo in red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk myelodyplastic syndromes (MDS) associated with a deletion (del) 5q[31] cytogenetic abnormality.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 162
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
- •Study population: Pre-Randomization Phase
- •1. Must understand and voluntarily sign an informed consent form
- •2. Must be = 18 years of age at the time of signing the informed consent form
- •3. Must be able to adhere to the study visit schedule and other protocol requirements
- •4. 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 study entry
- •5. Prior thalidomide allowed
- •6. Documented diagnosis of MDS that meets IPSS criteria for low- to intermediate-1-risk disease and has an associated del 5q[31] cytogenetic abnormality (the deleted chromosomal region must include 5q[31])
- •7. RBC transfusion-dependent anemia defined as not having any consecutive 56 days without a RBC transfusion within at least the immediate 112 days (4 months). Note: A 112 day documented transfusion history is required for subjects to enter the double-blind phase of the study.
- •Study population: Double-Blind Treatment Phase
- •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
- •4. Documented diagnosis of MDS that meets IPSS criteria for low- to intermediate-1-risk disease and has an associated del 5q[31] cytogenetic abnormality (the deleted chromosomal region must include 5q[31])
- •5. RBC transfusion-dependent anemia defined as not having any consecutive 56 days without a RBC transfusion within at least the immediate 112-days prior to randomization.
- •6. Adequate slides of baseline bone marrow aspirate, marrow aspirate iron stain, bone marrow biopsy, and peripheral blood smear have been sent to Central Reviewer
- •7. Baseline RBC transfusion requirement has been calculated
- •8. Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test prior to starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (oral, injectable, patches, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. WCBP must agree to have pregnancy tests every 4 weeks while on study drug.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Study population: Pre-Randomization Phase
- •1. Pregnant or lactating females.
- •2. Prior therapy with lenalidomide
- •3. Proliferative (WBC = 12,000/mL) chronic myelomonocytic leukemia (CMML)
- •4. Prior = grade-2 NCI CTCAE (v 3.0) allergic reaction to thalidomide
- •5. Prior desquamating (blistering) rash while taking thalidomide
- •6. Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for = 3 years
- •7. Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days
- •8. Less than 6 months since prior allogeneic bone marrow transplantation
- •9. Less than 3 months since prior autologous bone marrow or stem cell transplantation
- •10. Less than 28 days since prior myelosuppressive anticancer biologic therapy
- •11. Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
- •12. Use of androgens other than to treat hypogonadism is prohibited
- •13. Known HIV-1 positivity
- •14. Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study
- •Study population: Double-Blind Treatment Phase
- •1. Pregnant or lactating females
- •2. Prior therapy with lenalidomide
- •3. Proliferative (WBC = 12,000/mL) CMML
- •4. Any of the following laboratory abnormalities:
- •-Absolute neutrophil count (ANC) < 500 cells/mL (0.5 x 109/L)
- •-Platelet count < 25,000/µL (25 x 109/L)
- •-Serum creatinine > 2.0 mg/dL (177 mmol/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)
- •-Serum total bilirubin > 1.5 mg/dL
- •5. Prior = grade-2 NCI CTCAE allergic reaction to thalidomide
- •6. Prior desquamating (blistering) rash while taking thalidomide
- •7. Subjects with = grade-2 neuropathy
- •8. Clinically significant anemia owing to iron, B12, or folate deficiencies, or autoimmune or hereditary hemolysis or gastrointestinal bleeding (the subject must have a marrow aspirate that is evaluable for storage iron)
- •9. Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for = 3 years
- •10. Use of androgens other than to treat hypogonadism is prohibited
- •11. Known HIV-1 positivity
- •12. Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he/she participates in the study
研究者
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