JPRN-jRCT2080225312招募中1 期
Safety and Preliminary Efficacy of Epcoritamab (GEN3013; DuoBody-CD3XCD20) in Japanese Subjects with Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (B-NHL) - A Phase 1/2, Open-Label, Dose-Escalation Trial with Expansion Cohorts
Genmab US Inc.0 个研究点目标入组 73 人开始时间: 2020年8月13日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 73
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-Randomized Masking: None (Open Label)
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Main Inclusion Criteria:
- •- Must be at least 20 years of age, inclusive
- •- Japanese subjects
- •- CD20 positivity at representative tumor biopsy
- •- Diffuse large B-cell lymphoma (de novo or histologically transformed)
- •- High-grade B-cell lymphoma
- •- Primary mediastinal large B-cell lymphoma
- •- Follicular lymphoma
- •- Marginal zone lymphoma (nodal, extranodal of mucosa-associated lymphoid tissue, or splenic)
- •- Small lymphocytic lymphoma
- •b. Part 2 :
- •- Diffuse large B-cell lymphoma (de novo or histologically transformed)
- •- Follicular lymphoma grade 1-3A
- •- Relapsed or refractory disease and previously treated with at least 2 lines of systemic antineoplastic therapy including at least 1 anti-CD20 mAb-containing therapy.
- •- Measurable disease by CT, MRI or PET-CT scan
- •- R/R FL grade 1, 2 or 3a, stage II, III, or IV, without evidence of transformation.
- •- Previously treated with at least 1 prior anti-neoplastic agent, including anti-CD20 antibody
- •- Must have a need for treatment initiation based on symptoms and/ or disease burden (GELF criteria)
- •- Eligible to receive R2 per investigator determination
- •- One of following confirmed histologies (de novo or histologically transformed from FL or nodal marginal zone lymphoma) :
- •o DLBCL, NOS
- •o Double-hit or triple-hit DLBCL
- •- FL Grade 3B.
- •- T-cell/histiocyte rich LBCL
- •- International Prognostic Index (IPI) score ?3
- •- No prior therapy for DLBCL or FL G3B other than nodal biopsy, corticosteroids, or palliative radiotherapy.
- •- Eligible to receive R-CHOP per investigator determination
- •- One of following confirmed histologies (de novo or histologically transformed from FL or nodal marginal zone lymphoma) including:
- •o DLBCL, NOS.
- •o Double-hit or triple-hit DLBCL
- •o FL Grade 3B.
- •o T-cell/histiocyte rich LBCL
- •- Relapsed or refractory to at least one prior therapy including at least one prior anti-CD20 antibody.
- •- Either failed prior autologous hematopoietic stem cell transplantation (ASCT), or ineligible for autologous HSCT
- •- Eligible to receive GemOx per investigator determination
- •- History of histologically confirmed CD20+ FL Grade 1-3a without evidence of transformation.
- •- In CR or PR per Lugano criteria following first-line or second-line treatment with SOC regimen, including anti-CD20 antibody, and last dose of SOC within 6 months prior to enrollment
排除标准
- •Main Exclusion Criteria:
- •- Primary CNS lymphoma or CNS involvement by lymphoma at
- •- Subjects not eligible for high dose therapy with autologous
- •hematopoietic stem cell transplantation due to personal choice, social
- •issues, or similar
- •-Known clinically significant cardiac disease
- •- Chronic ongoing infectious diseases requiring treatment (excluding
- •prophylactic treatment)
- •Exclusion criteria for Part 2, Arms 2 through 5:
- •- FL Grade 3b
- •- Histologic evidence of transformation to an aggressive lymphoma
- •- Contraindication to rituximab or lenalidomide
- •- Unwilling or unable to take aspirin prophylaxis or prophylactic
- •anticoagulant as clinically indicated
- •- Contraindication to any of the individual drugs of the R-CHOP regimen
- •- Contraindication to any of the individual drugs of the GemOx regimen
- •- FL Grade 3b
- •- Histologic evidence of transformation to an aggressive lymphoma
研究者
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