EUCTR2007-000246-13-BE进行中（未招募）不适用
A phase II study of the efficacity and the safety of lenalidomide in subjects with intermediate or the high risk myelodysplastic syndromes (MSD) associated with a deletion (Del) 5q[31]
Groupe Français des myélodysplasies0 个研究点目标入组 50 人开始时间: 2007年3月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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. Age = 18 years at the time of signing the informed consent form
- •2. Must understand and voluntarily sign an 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 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 (RA, RARS, RAEB, RAEB-T and CMML with WBC < 13,000/mm3 according to FAB classification) that meets IPSS criteria for intermediate-2 or high-risk disease and has an associated del 5q[31] (the deleted chromosomal region must include 5q[31]), with or without additional cytogenetic abnormalities
- •7 Women of childbearing potential (WCBP?) must have a negative serum or urine pregnancy test 10 – 14 days and again within 24 hours prior to starting study drug. In addition, sexually active WCBP must agree to continued abstinence from heterosexual intercourse or use 2 adequate contraceptive methods, started at least one month prior to onset of treatment, and continued during the whole study until the first menstruations that follow treatment discontinuation (See appendix for acceptable methods). WCBP must agree to have pregnancy tests weekly for the first 4 weeks, then every 4 weeks if menstruation is regular or every 2 weeks if menstruation is irregular,while on study drug. Negativity of the test should be checked before restarting treatment
- •8Platelet count > 25,000u/L
- •9.Absolute Neutrophil count > 500u/L
- •? (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).
- •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
- •1.Pregnant or lactating females.
- •2.Prior therapy with lenalidomide
- •3.Proliferative (WBC = 13,000/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.Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
- •11.Use of androgens other than for treating hypogonadism
- •12.Known HIV-1 positivity
- •13. 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
- •14. Any of the following laboratory abnormalities:
- •?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,:
- •15.Subjects with = grade-2 neuropathy
- •16.Clinically significant anemia due 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)
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