EUCTR2020-004977-38-FR进行中（未招募）1 期
Phase II, Open-Label Study evaluating efficacy of Tafasitamab and Lenalinomide associated to Rituximabin frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or older
YSARC0 个研究点目标入组 71 人开始时间: 2021年4月8日最近更新:
适应症
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
- 71
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Patient with histologically proven CD20+ diffuse large B-cell lymphoma (DLBCL) (WHO classification 2017) including all clinical subtypes (primary mediastinal, intravascular, etc…), with all aaIPI. May also be enrolled the following malignancies:
- •De Novo transformed DLBCL from low grade lymphoma (Follicular, other...) and DLBCL associated with some small cell infiltration in bone marrow or lymph node.
- •High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements
- •High-grade B-cell lymphoma, NOS
- •Follicular lymphoma grade 3B
- •Previously untreated high-grade B-cell lymphoma
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 71
排除标准
- •1.Any other histological type of lymphoma, Burkitt included
- •2.Any history of treated or non-treated Small-B cell lymphoma prior Aggressive B Cell lymphoma diagnosis
- •3.Central nervous system or meningeal involvement by lymphoma
- •4.Any serious active disease (according to the investigator’s decision)
- •5.Poor renal function (calculated MDRD or Cockcroft-Gault creatinine clearance < 30 ml/min)
- •6.Poor hepatic function (total bilirubin level >30 µmol/l, transaminases >2.5 upper normal limits) unless these abnormalities are related to lymphoma
- •7.Poor bone marrow reserve as defined by neutrophils <1.5 G/l or platelets <100 G/l, unless related to bone marrow infiltration by lymphoma cells (Bone Marrow Aspiration will be mandatory in case of severe cytopenias prior inclusion)
- •8.Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Patients previously diagnosed with prostate cancer are eligible if (1) their disease was T1-T2a, N0, M0, with a Gleason score =7, and a prostate specific antigen (PSA) =10 ng/mL prior to initial therapy, (2) they had definitive curative therapy (i.e., prostatectomy or radiotherapy) 2 years before Day 1 of Cycle 1, and (3) at a minimum 2 years following therapy they had no clinical evidence of prostate cancer, and their PSA was undetectable if they underwent prostatectomy or <1 ng/mL if they did not undergo prostatectomy
- •9.Treatment with any investigational drug within 30 days prior to prephase treatment and during the study
- •10.Known HIV, active HCV infection or positive HBV test within 4 weeks before enrollment (except after hepatitis B vaccination or for patients who are HBs Ag negative, anti-HBs positive and/or anti-HBc positive but viral DNA negative)
- •11.Prior treatment with anti-CD20/anti-CD19 monoclonal antibody or alemtuzumab within 3 months prior to prephase treatment
- •12.Prior = Grade 3 allergic reaction/hypersensitivity to thalidomide
- •13.Contra-indication to highly dosed glucocorticoid (60 mg/m2/d)
- •14.Neuropathy = Grade 2 or painful
- •15.Patient deprived of his/her liberty by a judicial or administrative decision
- •16.Adult patient under legal protection
研究者
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