EUCTR2004-004349-16-BE进行中（未招募）1 期
Targeted Intensification by a new preparative regimen for patients with Low-Grade B-Cell Lymphoma utilizing standard dose Ytrium 90 Ibritumomab Tiuxetan (Zevalin) radioimmunotherapy (RIT) combined with high dose BEAM followed by autologous stem cell transplantation (ASCT) - Z-BEAM
GELA Group0 个研究点目标入组 0 人开始时间: 2006年1月31日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 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
- •-Aged from 18 to 65 years
- •-patient with pathologically proven at relapse, low grade B-Cell lymphoma CD20+: Marginal zone or Lymphocytic or Follicular
- •-In relapse after CR, less than PR o partial response (max 3 lines of treatment)
- •-Previously treated with or without chemotherapy regimen containing rituximab
- •-With chemo-sensitive disease using salvage therapy
- •-Eligible for autologous stem cell transplantation
- •-With a minimum life expectancy of 3 months
- •-Negative HIV, HBV and HCV serologies
- •-signed informed consent form
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Histological transformation in diffuse large cell from a low grade B-Cell lymphoma
- •-Prior transplantation
- •-Contraindication to any drug contained in the chemotherapy regimens
- •-Large bonne marrow irradiation> 40%
- •-Bone marrow infiltration > 25%
- •-Lack of suffiscient autologous stem cell transplantation
- •-Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study
- •-Ay serious active disease or co-morbid medical condition
- •-Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100G/l, unless related to bone marrow infiltration
- •-Poor renal function
- •-Poor hepatic function
- •-Any history of cancer during the last 5 years
- •-Presence of anti-murine antibody (HAMA) reactivity
- •-Known hypersensitivity to murine antibodies or proteins
- •-Pregnant woman
- •-Adult patient unable to give informed consent because of intellectual impairement
研究者
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TARGETED INTENSIFICATION BY A PREPARATIVE REGIMEN FOR PATIENTS WITH HIGH-GRADE B-CELL LYMPHOMA UTILIZING STANDARD-DOSE YTTRIUM-90 IBRITUMOMAB TIUXETAN (ZEVALIN) RADIOIMMUNOTHERAPY (RIT) COMBINED WITH HIGH-DOSE BEAM FOLLOWED BY AUTOLOGOUS STEM CELL TRANSPLANTATION (ASCT):Z BEAM 2Diffuse Large B cell LymphomaMedDRA version: 9.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphomaEUCTR2007-000270-23-BEGELA75
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