EUCTR2013-004341-17-GB进行中（未招募）1 期
A Multicenter Open-Label Phase 1b/2 Study of the Bruton’s Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination with Lenalidomide and Rituximab in Subjects with Relapsed or Refractory Diffuse Large B-Cell Lymphoma.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 83
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
- •· Pathologically confirmed relapsed/ refractory DLBCL
- •· Must have previously received first line treatment regimen
- •· Must be ineligible for high dose therapy/ stem cell transplantation
- •· Measurable disease sites on CT scan (>1.5 cm in longest dimension)
- •· PT/INR <1.5 x ULN and PTT (aPTT) <1.5 x ULN
- •· Men and women =18 years of age
- •· ECOG < 2
- •· Adequate hepatic and renal function
- •· Adequate hematologic function
- •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 22
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 33
排除标准
- •· Medically apparent central nervous system lymphoma or leptomeningeal disease
- •· History of allogeneic stem-cell (or other organ) transplantation
- •· Any chemotherapy, external beam radiation therapy, or anticancer antibodies within 2 weeks
- •· Radio- or toxin-immunoconjugates within 10 weeks
- •· Concurrent enrollment in another therapeutic investigational study or have previously taken ibrutinib and/or lenalidomide.
研究者
相似试验
进行中（未招募）
1 期
Safety and Efficacy of ibrutinib in combination with lenalidomide and rituximab in patients with previously treated Diffuse Large B-Cell LymphomaRelapsed or Refractory Diffuse Large B-Cell LymphomaMedDRA version: 21.0Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-004341-17-BEPharmacyclics LLC83
进行中（未招募）
1 期
A clinical study to assess the safety and effectiveness of Ibrutinib in subjects with relapsed/refractory marginal zone lymphoma.Relapsed or refractory marginal zone lymphomaMedDRA version: 19.1Level: HLTClassification code 10029621Term: Non-Hodgkin's lymphomas unspecified histology indolentSystem Organ Class: 100000004851EUCTR2013-003561-34-BEPharmacyclics LLC60
进行中（未招募）
1 期
A clinical study to assess the safety and effectiveness of Ibrutinib in subjects with relapsed/refractory marginal zone lymphoma.Relapsed or refractory marginal zone lymphomaMedDRA version: 17.1Level: HLTClassification code 10029621Term: Non-Hodgkin's lymphomas unspecified histology indolentSystem Organ Class: 100000004851EUCTR2013-003561-34-DEPharmacyclics Incorporated60
进行中（未招募）
1 期
A clinical study to assess the safety and effectiveness of Ibrutinib in subjects with relapsed/refractory marginal zone lymphoma.Relapsed or refractory marginal zone lymphomaMedDRA version: 19.1 Level: HLT Classification code 10029621 Term: Non-Hodgkin's lymphomas unspecified histology indolent System Organ Class: 100000004851EUCTR2013-003561-34-GBPharmacyclics LLC63
进行中（未招募）
1 期
A study, testing the safety and effectiveness of an experimental drug known as B-701, that binds to a protein receptor called FGFR3, and another type of anti-cancer drug known as Pembrolizumab in Subjects with bladder cancer that recurred or got worse following treatment with standard therapy.ocally advanced or Metastatic Urothelial CarcinomaMedDRA version: 20.0 Level: PT Classification code 10005005 Term: Bladder cancer recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001292-23-FRBioClin Therapeutics, Inc.92