EUCTR2010-020868-38-IT进行中（未招募）不适用
(A Phase 2) STUDY TO DETERMINE THE EFFICACY AND SAFETY OF LENALIDOMIDE AND LOW-DOSE DEXAMETHASONE (Rd) FOLLOWED BY RITUXIMAB, AUTOGRAFT AND LENALIDOMIDE MAINTENANCE IN NEWLY DIAGNOSED WALDESTROM MACROGLOBULINEMIA SUBJECTS - ND
.O.C. EMATOLOGIA - OSP. S. EUGENIO - ASL RM C0 个研究点开始时间: 2010年12月22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
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
- •Clinico-pathological diagnosis of Waldenstrom`s macroglobulinemia using consensus panel criteria • Baseline staging requirements • Age from 18 to 75 years • CD20 positive based on any previous bone marrow immunohistochemistry or flow cytometric analysis • Measurable disease • ECOG performance status of 0-2 • Absolute neutrophil count = 1000/ul • Platelet count = 50000 /ul • Hemoglobin > 10 g/dL • Calculated or measured creatinine clearance: = 30 mL/minute • Total bilirubin < 1.5 mg/dL • AST and ALT < 2.5 x ULN • Disease free of prior malignancies fir 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix or breast • Female patient is either post-menopausal for 24 consecutive months or surgically sterilized or agree to continuous abstinence from heterosexual sexual contact or willing to use two acceptable method of birth control at the same time (one highly effective method and one additional effective method) (Highly Effective Methods: Intrauterine device -IUD-; Hormonal -birth control pills, injections, implants-; tubal ligation; partner’s vasectomy; Additional Effective Methods: Latex condom; Diaphragm; Cervical Cap) for 4 weeks prior to beginning study drug therapy, during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy. • Negative serum Beta-human chorionic gonadotropin (?Beta-HCG) pregnancy test both 24 hours prior to beginning of therapy and then at 4 weeks intervals in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles during study treatment for subjects of childbearing potential. • Male patient agrees to use an acceptable method for contraception (i.e., condom or abstinence) during study drug therapy (including dose interruption) and for 4 weeks after discontinuation of lenalidomide therapy.
- •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
- •Chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry • Concurrent use of other anti-cancer agents or treatments • Pregnant or lactating women • Serious co-morbid disease • Uncontrolled bacterial, fungal or viral infection • Active second malignancy • Development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs.
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