EUCTR2011-002565-38-ES进行中（未招募）1 期
A Phase 2 Randomized Open-label Study of MEDI-551 in Adults With Relapsed or Refractory DLBC
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 187
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
- •? Histologically confirmed aggressive B-cell DLBCL, including FL transforming to DLBCL & Grade III FL
- •? Relapsed from or refractory to at least one treatment containing rituximab or another anti-CD20 based immunotherapy combined with anthracycline- or anthracenedione-based chemotherapy
- •? Eligible for ASCT
- •? Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •? Life expectancy of ? 12 weeks
- •? Adequate hematological 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 130
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •? Any chemotherapy, radiotherapy, immunotherapy, biologic, investigational or hormonal therapy for treatment of lymphoma within 28 days prior to treatment
- •? Previous cancer therapy for DLBCL other than anthracycline- or anthracenedione based chemoimmunotherapy, monotherapy rituximab prior to first line therapy and/or as a maintenance therapy, or limited field radiotherapy
- •? Prior autologous or allogeneic SCT
- •? New York Heart Association ? Class II congestive heart failure;
- •? Clinically significant abnormality on ECG
- •? History of other invasive malignancy within 5 years except for localized/in situ, carcinomas such as cervical carcinoma in situ.
- •? Evidence of active infection
- •? Documented current central nervous system involvement by leukemia or lymphoma
研究者
相似试验
进行中（未招募）
1 期
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Relapsed or refractory diffuse large B-cell lymphoma(DLBCL)MedDRA version: 18.1Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.1Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-002565-38-DEMedImmune, LLC180
进行中（未招募）
不适用
A Phase 2 Randomized Open-label Study of MEDI-551 in AdultsWith Relapsed or Refractory DLBCRelapsed or Refractory Diffuse Large B-cell Lymphoma .(DLBCL)MedDRA version: 14.1Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-002565-38-ITMEDIMMUNE ONCOLOGY INC170
进行中（未招募）
1 期
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Relapsed or refractory diffuse large B-cell lymphoma(DLBCL)MedDRA version: 17.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-002565-38-CZMedImmune, LLC170
进行中（未招募）
1 期
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)EUCTR2011-002565-38-PLMedImmune, LLC180
进行中（未招募）
1 期
A Phase 2, Multicenter, Randomized, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)Relapsed or refractory diffuse large B-cell lymphoma(DLBCL)MedDRA version: 18.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 18.0Level: PTClassification code 10012818Term: Diffuse large B-cell lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-002565-38-HUMedImmune, LLC187