NCT06356129进行中（未招募）3 期
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Comparing the Efficacy and Safety of Golcadomide Plus R-CHOP Chemotherapy vs Placebo Plus R-CHOP Chemotherapy in Participants With Previously Untreated High-risk Large B-cell Lymphoma (GOLSEEK-1)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Celgene
- 入组人数
- 850
- 试验地点
- 644
- 主要终点
- Progression-free survival (PFS) assessed by the Investigator
研究概览
简要总结
The purpose of this study is to compare the effectiveness and safety of golcadomide in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy vs placebo in combination with R-CHOP chemotherapy in participants with previously untreated high-risk large B-cell lymphoma (LBCL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including:
- •i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal center B-cell (GCB) and activated B-cell (ABC) types]
- •ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements (HGBL-MYC/BCL2 double-hit lymphomas)
- •iii) High-grade B-cell lymphoma, not otherwise specified
- •iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL)
- •v) Epstein-Barr virus + DLBCL
- •International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) > 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥
- •Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification.
- •Must have Ann Arbor Stage II-IV disease.
排除标准
- •Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
- •Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, indolent lymphoma transformed to large B-cell lymphoma (LBCL), Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma.
- •Documented or suspected central nervous system (CNS) involvement by lymphoma.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)
Experimental
干预措施: Rituximab (Drug)
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)
Experimental
干预措施: Golcadomide (Drug)
Placebo + R-CHOP
Placebo Comparator
干预措施: Placebo (Drug)
Placebo + R-CHOP
Placebo Comparator
干预措施: Vincristine (Drug)
Placebo + R-CHOP
Placebo Comparator
干预措施: Cyclophosphamide (Drug)
Placebo + R-CHOP
Placebo Comparator
干预措施: Doxorubicin (Drug)
Placebo + R-CHOP
Placebo Comparator
干预措施: Prednisone (Drug)
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)
Experimental
干预措施: Cyclophosphamide (Drug)
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)
Experimental
干预措施: Doxorubicin (Drug)
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)
Experimental
干预措施: Prednisone (Drug)
Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)
Experimental
干预措施: Vincristine (Drug)
Placebo + R-CHOP
Placebo Comparator
干预措施: Rituximab (Drug)
结局指标
主要结局
Progression-free survival (PFS) assessed by the Investigator
时间窗: Up to approximately 67 months
Progression-free survival (PFS) assessed by the Investigator
时间窗: Approximately 24 months after the last participant's first treatment
次要结局
- Overall survival (OS)(Up to approximately 67 months)
- Second progression-free survival (PFS2) assessed by the Investigator(Up to approximately 67 months)
- PFS assessed by the Investigator(Up to approximately 67 months)
- Event-free survival (EFS)(Up to approximately 67 months)
- Complete Metabolic Response assessed by the Independent Response Adjudication Committee (IRAC)(Up to approximately 18 weeks)
- Minimal residual disease (MRD) negativity rate(Up to approximately 18 weeks)
- Progression-free survival (PFS) assessed by the IRAC(Up to approximately 47 months)
- Objective response (OR) assessed by the Investigator(Up to approximately 18 weeks)
- Complete metabolic response (CMR) assessed by the Investigator(Up to approximately 18 weeks)
- PFS24 assessed by the Investigator 24 months after randomization(Up to 24 months)
- Duration of response (DoR)(Up to approximately 67 months)
- Relative dose intensity (%)(Up to 18 weeks)
- Number of participants with Adverse Events (AEs)(Up to approximately 20 weeks)
- Mean change from baseline in the EORTC QLQ-C30(Up to approximately 67 months)
- Mean change from baseline in the FACT-LymS(Up to approximately 67 months)
- Number of participants with treatment-emergent adverse events (TEAEs)(Up to approximately 20 weeks)
- Number of participants with laboratory abnormalities(Up to approximately 20 weeks)
- Number of participants with vital sign abnormalities(Up to approximately 20 weeks)
- Time from randomization to meaningful improvement in primary domains of interest in the European Organization for Research and Treatment of Cancer - Quality of Life C30 (EORTC QLQ-C30) Questionnaire(Up to approximately 67 months)
- Time from randomization to meaningful improvement in primary domains of interest in the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS) Questionnaire(Up to approximately 67 months)
- PFS assessed by the Investigator(Approximately 24 months after the last participant's first treatment)
- Event-free survival (EFS)(Approximately 24 months after the last participant's first treatment)
- Progression-free survival (PFS) assessed by the IRAC(Approximately 24 months after the last participant's first treatment)
- Number of participants with Adverse Events (AEs)(Up to approximately 22 weeks)
- Number of participants with treatment-emergent adverse events (TEAEs)(Up to approximately 22 weeks)
- Number of participants with laboratory abnormalities(Up to approximately 22 weeks)
- Number of participants with vital sign abnormalities(Up to approximately 22 weeks)
研究者
研究点 (644)
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