EUCTR2013-005129-22-IT进行中（未招募）不适用
FASE II STUDY WITH BORTEZOMIB, RITUXIMAB AND BENDAMUSTIN –BRB- FOR NON-HODGKIN LYMPHOPLASMACYTIC LYMPHOMA/WALDENSTROM MACROGLOBULINEMIA’S PATIENTS AT FIRST RELAPSE
Fondazione Italiana Linfomi0 个研究点开始时间: 2014年3月17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
- •-Histological proven diagnosis of Lymphoplasmacytic/citoid lymphoma/Waldenstrom macroglobulinemia according to REAL/WHO Classification
- •-Relapsed/refractory disease after receiving one line chemotherapy
- •-Age >= 18
- •-Presence of at least one of the following criteria for the definition of active disease: Systemic symptoms or Hemoglobin less than 10 g/dL (due to lymphoma) or Platelets less than 100 x 109/L (due to lymphoma) or symptomatic splenomegaly or Bulky disease (>7 cm) or Hyperviscosity syndrome, peripheral neuropathy up to grade 1 (Waldenstrom's disease-related) , hemolytic anemia, and immune complex vasculitis
- •-Life expectancy >6 months
- •-ECOG performance status 0- 2
- •-LVEF =45% or FS =37%
- •-Creatinine up to 1.5 x ULN
- •-Conjugated bilirubin up to 2 x ULN
- •-Alkaline phosphatase and transaminases up to 2 x ULN
- •-Written informed content
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 31
排除标准
- •-Patients not agreeing to take adequate contraceptive precautions during and for at least 6 months after cessation of therapy
- •-History of other malignancies within 3 years prior to study entry except for: adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low grade, early stage, localized prostate cancer treated surgically with curative intent; good prognosis DCIS of the breast treated with lumpectomy alone with curative intent
- •-Medical condition requiring long term use (>1 months) of systemic corticosteroids
- •-Active bacterial, viral, or fungal infection requiring systemic therapy
- •-Peripheral neuropathy of any grade >=2
- •-Concurrent medical condition which might exclude administration of therapy
- •-Cardiac insufficiency (NYHA grade III/IV)
- •-Myocardial infarction within 6 months of entry on study
- •-Severe chronic obstructive pulmonary disease with hypoxemia
- •-Severe diabetes mellitus difficult to control with adequate insulin therapy
- •-Hypertension that is difficult to control
- •-Impaired renal function with creatinine clearance <30 ml/min
- •-HIV positivity
- •-HBV positivity with the exception of patients HbsAg and HBV-DNA negative and Ab anti-HBcore positive (these patients need to receive prophylaxis with Lamivudine)
- •-HCV positivity with the exception of patients with HCV RNA negative
- •-Participation at the same time in another study in with investiogational drugs are used
- •-Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
- •-Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent.
- •-Women in pregnancy or breastfeeding
研究者
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