EUCTR2007-003657-87-IT进行中（未招募）1 期
Reduced intensity conditioning with high-dose rituximab followed by allogeneic transplantation of hematopoietic cells for the treatment of relapsed/refractory B-cell non Hodgkin?s lymphomas - ND
ISTITUTO NAZIONALE PER LA CURA TUMORI0 个研究点目标入组 190 人开始时间: 2008年2月12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
- 入组人数
- 190
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 ≤ 65 years 2. Histologies as follow: 2a.Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) relapsing after at least 2 lines of conventional chemotherapy or relapsing after a first line (within one year) including purine analogue-based regimen or relapsing after autologous stem cell transplantation (as first or second line) 2b. Primary refractory CLL or SLL 2c.Follicular lymphomas (FCL) relapsing after 2 lines or relapsing after autologous stem cell transplantation 2d.Primary refractory FCL 2e.Mantle cell lymphomas (MCL) relapsing after conventional chemotherapy or autologous stem cell transplantation 2f.Diffuse large B-cell lymphomas (DLBCL) or transformed FCL relapsing after two lines of conventional chemotherapy or autologous stem cell transplantation 2g.CLL, FCL, MCL and DLBCL considered eligible for high-dose chemotherapy, with a positive bone marrow biopsy or collecting PCR positive harvests before the autografting phase 3. PS (Karnofsky) 70% 4. HLA-identical (A, B, C, DR, DQ loci) or one antigen mismatched (class I) sibling donors 5. Written informed consent
- •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
- •1. Central nervous system localization 2. Positive serologic markers for human immunodeficiency virus (HIV) 3. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 4. Serum bilirubin levels > 2 the upper normal limit 5. Ejection fraction < 45% (or myocardial stroke in the last year) 6. Clearance of creatinine < 50 ml/min 7. DLCO < 50% 8. Pregnancy or lactation 9. Patient not agreeing to take adequate contraceptive measures during the study 10. Psychiatric disease 11. Any active, uncontrolled infection 12. Type I hypersensivity or anaphylactic reactions to rituximab
研究者
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撤回
3 期
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