EUCTR2013-001065-17-ES进行中（未招募）1 期
Phase II, randomised, multicentre study with two treatment arms (R-COMP versus R-CHOP) in newly diagnosed elderly patients (?60 years) with non-localised diffuse large B-cell lymphoma (DLBCL)/follicular lymphoma grade IIIb.
Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea (GEL/TAMO)0 个研究点目标入组 90 人开始时间: 2013年6月10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
- 90
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.? 60 years of age
- •2.Histological confirmed DLBCL/follicular lymphoma grade IIIb by WHO classification, with any IPI (International Prognostic Index)
- •3.Newly diagnosed, with no previous treatment
- •4.Non-localised stage, i.e. lymphoma that does not fit into a single radiotherapy field (including clinical stage IA with large tumour mass until stage IV) with at least one measurable lesion
- •5.ECOG performance status 0 to 2
- •6.Present appropriate haematologic, liver (ALT or AST < 2.5 ULN ? upper limit of normal) and renal functions (creatinine < 2.5 ULN) , unless changes are secondary to lymphoma
- •7.LVEF at rest ? 55%, with no documented history of congestive heart failure (CHF), serious arrhythmia or acute myocardial infarction
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1.Clinical stage I without large tumour mass or clinical stage IIA with fewer than three affected areas (stage-IIB patients are considered suitable, regardless of the number of affected areas)
- •2.CNS infiltration
- •3.Transformed lymphoma, although with no previous treatment, as well as other histological subtypes such as mantle cell lymphoma, peripheral T-cell lymphoma and its variants and post-transplant lymphoproliferative syndrome
- •4.Clinically significant secondary cardiovascular disease
- •5.Signs of any severe, acute or chronic and active infection
- •6.Concurrent malignancy or history of other neoplasia except basal cell carcinoma (BCC) and cervical or breast carcinoma in situ (CIN)
- •7.Patients with positive results in the HBV, HIV or HCV RNA tests
- •8.Any previous treatment for DLBCL/follicular lymphoma grade IIIb
研究者
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