NCT00874978已完成2 期
The Efficacy and Safety of Lenalidomide (Revlimid®) Monotherapy in Red Blood Cell Transfusion Dependent Subjects With Myelodysplastic Syndrome Associated With Del (5q) Cytogenetic Abnormality
King's College Hospital NHS Trust1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2005年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Red blood cell (RBC) transfusion independence.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of lenalidomide treatments to achieve haematopoietic improvement in subjects with low- or intermediate-1 risk International Prognostic Scoring System1 (IPSS) myelodysplastic syndrome (MDS) associated with a del (5q31-33) cytogenetic abnormality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and voluntarily sign an informed consent form.
- •Age over or equal to 18 years at the time of signing the informed consent form.
- •Able to adhere to the study visit schedule and other protocol requirements.
- •Diagnosis of low- or intermediate-1-risk (IPSS) MDS associated with a del(5q) cytogenetic abnormality. The cytogenetic abnormality of chromosome 5 must involve a deletion between bands q31 and q
- •The del(5q) cytogenetic abnormality may be an isolated finding or may be associated with other cytogenetic abnormalities.
- •RBC transfusion-dependent anaemia defined as having no transfusion free interval of < 56 consecutive days within the past 112 days.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or
- •Women of childbearing potential (WCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL 10 - 14 days prior to therapy and repeated within 24 hours of starting study drug and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 4 weeks before she starts taking lenalidomide. Women must also agree to ongoing pregnancy testing. Men must agree not to father a child and agree to use a condom if his partner is of child bearing potential.
- •Laboratory test results within these ranges:
- •Absolute neutrophil count over or equal to 0.5 x 109/L
- •Platelet count over or equal to 25 x 109/L
- •Serum creatinine under or equal to 2.0 mg/dl
- •Total bilirubin under or equal to 1.5 mg/dl
- •AST (SGOT) and ALT (SGPT) under or equal to 3 x ULN.
- •Disease free of prior malignancies for over or equal to 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in-situ" of the cervix or breast.
排除标准
- •Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
- •Pregnant or lactating females.
- •Prior > grade 3 (National Cancer Institute [NCI] Common Toxicity Criteria [CTC]) allergic reaction to thalidomide.
- •Prior > grade 3 (NCI CTC) rash or any desquamation (blistering) while taking thalidomide.
- •Clinically significant anaemia due to factors such as iron, B12 or folate deficiencies,autoimmune or hereditary haemolysis or gastrointestinal bleeding (if a marrow aspirate is not evaluable for storage iron, transferrin saturation must be > 20 % and serum ferritin not less than 50 ng/ml).
- •Use of haematopoietic growth factors within 7 days of the first day of study drug treatment. Use of G-CSF is permitted.
- •Concurrent use of erythropoietin
- •Chronic use (>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to >10 mg/day of prednisolone) within 28 days of the first day of study lenalidomide treatment.
- •Use of experimental or standard drugs (i.e. chemotherapeutic, immunosuppressive, and cytoprotective agents) for the treatment of MDS within 28 days of the first day of study lenalidomide treatment.
- •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.
- •Any prior use of lenalidomide.
- •Concurrent use of other anti-cancer agents or treatments. Patients must not have received any form of chemotherapy for at least 4 weeks prior to study entry and must have fully recovered from haematological toxicity associated with this therapy.
- •Known positive for HIV or infectious hepatitis, type A, B or C.
研究组 & 干预措施
lenalidomide
Experimental
干预措施: lenalidomide (Drug)
结局指标
主要结局
Red blood cell (RBC) transfusion independence.
时间窗: monthly
次要结局
- Change of haemoglobin concentration from baseline(every 2 and 4 weeks)
- Safety (type, frequency, severity, and relationship of adverse events to lenalidomide)(monthly)
- Over or equal to 50% decrease in RBC transfusion requirements(monthly)
- Bone marrow response(3, 6 and 12 months)
- Duration of response(monthly)
- Cytogenetic response(3, 6 and 12 months)
- Platelet response(every 2 and 4 weeks)
- Gene expression profiling of patients with the 5q- syndrome and effects of lenalidomide on gene expression profiles(3, 6 and 12 months)
- Neutrophil response(every 2 and 4 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line TherapyB-cell Chronic Lymphocytic LeukemiaNCT00774345Celgene317
Unknown
不适用
Lenalidomide in the Treatment of Refractory Cutaneous DermatomyositisDermatomyositisNCT05488327Jiangxi Provincial People's Hopital10
进行中（未招募）
1 期
The purpose of the study is to determine if the drug lenalidomide (Revlimid®) is able to improve anaemia (low red blood count) and reduce the number of blood transfusions that you require because of Myelodysplastic Syndrome (MDS). The other purpose of the study is to evaluate the effect of the study drug (lenalidomide) on the genetic abnormality (changes in the cell characteristics) associated with MDS.Myelodysplastic Syndrome (MDS) associated with a Del (5q) cytogenetic abnormalityMedDRA version: 16.0 Level: LLT Classification code 10067097 Term: 5q minus MDS System Organ Class: 100000004864EUCTR2004-005101-29-GBKing's College Hospital NHS Foundation Trust44
终止
2 期
Lenalidomide (Revlimid®) as Second Line Therapy in Patients With Chronic Graft-Vs-Host Disease (GVHD)Graft-versus-Host DiseaseNCT00675441M.D. Anderson Cancer Center5
Unknown
2 期
The Treatment of Lenalidomide in Patients With POEMS SyndromePOEMS SyndromeNCT00971685Istituto Clinico Humanitas16