NL-OMON53475招募中2 期
Phase 1b/2, Open Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma - M22-132
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- AbbVie B.V.
- 入组人数
- 10
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adult male or female, at least 18 years old 2. Diagnosis of DLBCL with
- •histologically confirmed CD20+ disease, inclusive of the following according to
- •WHO 2016 classification and documented in pathology report: • DLBCL, not
- •otherwise specified (NOS) • High-grade B cell lymphoma with MYC and BCL-2
- •and/or BCL-6 translocations per WHO 2016 (*double-hit* or *triple-hit*) Note:
- •High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with
- •histologies not consistent with DLBCL) are not eligible • Follicular lymphoma
- •Grade 3B 3. Subject must have Eastern Cooperative Oncology Group (ECOG)
- •performance status 0 - 2 4. Subject must have 1 or more measurable disease
- •sites: • A positron emission tomography/computed tomography (PET/CT) scan
- •demonstrating PET-positive lesion(s) AND • At least 1 measurable nodal lesion
- •(long axis >= 1.5cm and short axis > 1.0 cm) or >= 1 measurable extra-nodal
- •lesion (long axis >= 1.0 cm) on CT scan or MRI
排除标准
- •1.Diagnosis of High-grade B-cell lymphomas NOS or other double-/triple-hit
- •lymphomas (with histologies not consistent with DLBCL)
- •2. Subjects who have had prior treatment with epcoritamab or any other
- •bispecific antibody targeting CD3 and CD20
研究者
相似试验
进行中（未招募）
1 期
This study is to evaluate the safety and tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin LymphomaEUCTR2021-005725-24-DKAbbVie Deutschland GmbH & Co. KG394
进行中（未招募）
1 期
This study is to evaluate the safety and tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin LymphomaB-cell Non-Hodgkin's lymphoma, diffuse large B-cell lymphomaMedDRA version: 21.0Level: PTClassification code 10003903Term: B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2021-005725-24-ESAbbVie Deutschland GmbH & Co. KG132
进行中（未招募）
1 期
This study is to evaluate the safety and tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin LymphomaEUCTR2021-005725-24-NLAbbVie Deutschland GmbH & Co. KG394
进行中（未招募）
1 期
This study is to evaluate the safety and tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin LymphomaB-cell Non-Hodgkin's lymphoma, diffuse large B-cell lymphomaMedDRA version: 21.0Level: PTClassification code 10003903Term: B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.0Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2021-005725-24-DEAbbVie Deutschland GmbH & Co. KG394
招募中
1 期
This study is to evaluate the safety and tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin LymphomaB-cell Non-Hodgkin's lymphoma, diffuse large B-cell lymphomaMedDRA version: 20.0Level: HLGTClassification code: 10025320Term: Lymphomas non-Hodgkin's B-cell Class: 10029104MedDRA version: 21.0Level: PTClassification code: 10003903Term: B-cell lymphoma refractory Class: 100000004864MedDRA version: 21.0Level: PTClassification code: 10012822Term: Diffuse large B-cell lymphoma refractory Class: 100000004864CTIS2023-505347-38-00AbbVie Deutschland GmbH & Co. KG87