NCT04404283进行中（未招募）3 期
A Randomized, Double-blind, Placebo-Controlled, Active-Comparator, Multicenter, Phase 3 Study of Brentuximab Vedotin or Placebo in Combination With Lenalidomide and Rituximab in Subjects With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 239
- 试验地点
- 279
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Participants in this study will have diffuse large B-cell lymphoma (DLBCL) that has come back or not gotten better with treatment. The trial will study whether brentuximab vedotin plus two drugs works better to treat this type of cancer than the two drugs alone.
Participants will be randomly assigned to get either brentuximab vedotin or placebo. The placebo will look like brentuximab vedotin, but has no medicine in it. Since the study is "blinded," participants and their doctors will not know whether a participant gets brentuximab vedotin or placebo. All participants in the study will get rituximab and lenalidomide. These are drugs that can be used to treat DLBCL.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with relapsed or refractory diffuse and transformed large B-cell lymphoma (R/R DLBCL). DLBCL and cell of origin (GCB versus non-GCB) will be histologically determined by local pathology assessment for the purposes of study eligibility and stratification.
- •Participants must have R/R disease following 2 or more lines of prior systemic therapy.
- •For participants with transformed DLBCL, at least the last systemic therapy used must have been for DLBCL
- •Participants must be HSCT or CAR-T ineligible according to the investigator and must meet at least one of the following criteria:
- •One or more co-morbidities, including cardiac, pulmonary, renal or hepatic dysfunction that in the opinion of the Investigator make the participant medically unfit to received HSCT or CAR-T therapy
- •Active disease following induction and salvage chemotherapy
- •Inadequate stem cell mobilization (for HSCT)
- •Relapse following prior HSCT or CAR-T
- •Unable to receive CAR-T therapy due to financial, geographic, insurance, or manufacturing issues
- •Participants must have tumor tissue submitted to the central pathology lab. The tumor tissue submitted should be from the most recent biopsy that contains DLBCL.
- •An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2
- •Participants must have fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and bidimensional measurable disease of at least 1.5 cm by computed tomography (CT), as assessed by the site radiologist within 28 days of Day 1.
排除标准
- •History of another malignancy within 2 years before the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy
- •History of progressive multifocal leukoencephalopathy (PML)
- •Active cerebral/meningeal disease related to the underlying malignancy. Participants with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior CNS disease has been effectively treated and without progression for at least 3 months.
- •Any uncontrolled Grade 3 or higher (per NCI CTCAE version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted
- •Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 3 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
- •Previous treatment with brentuximab vedotin or lenalidomide.
- •Previous treatment with other vedotin-based ADCs is permitted if the last dose is at least 6 months prior to Day
- •Current therapy with immunosuppressive medications (including steroids), other systemic anti-neoplastic, or investigational agents
- •a) Prednisone (or equivalent) ≤10 mg/day may be used for non-lymphomatous purposes
- •Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association (NYHA) Class III-IV within 6 months prior to the first dose of study drugs
- •Congestive heart failure, Class III or IV, by the NYHA criteria
- •Grade 2 or higher peripheral sensory or motor neuropathy at baseline
研究组 & 干预措施
Experimental Arm
Experimental
Brentuximab vedotin + lenalidomide + rituximab
干预措施: Rituximab (Drug)
Experimental Arm
Experimental
Brentuximab vedotin + lenalidomide + rituximab
干预措施: Brentuximab vedotin (Drug)
Control Arm
Active Comparator
Placebo + lenalidomide + rituximab
干预措施: Placebo (Other)
Experimental Arm
Experimental
Brentuximab vedotin + lenalidomide + rituximab
干预措施: Lenalidomide (Drug)
Control Arm
Active Comparator
Placebo + lenalidomide + rituximab
干预措施: Rituximab (Drug)
Control Arm
Active Comparator
Placebo + lenalidomide + rituximab
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Approximately 2 years
OS is defined as the time from the date of randomization to date of death due to any cause
次要结局
- Progression-free survival (PFS)(Approximately 1 year)
- Incidence of adverse events(Approximately 1 year)
- OS in CD30+ participants(Approximately 2 years)
- Objective response rate (ORR)(Approximately 1 year)
- Complete response (CR) rate(Approximately 1 year)
- Duration of response (DOR)(Approximately 1 year)
研究者
研究点 (279)
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相关资讯
FDA Approves Brentuximab Vedotin Combination for Relapsed/Refractory Large B-Cell Lymphoma- The FDA has approved brentuximab vedotin in combination with lenalidomide and rituximab for adult patients with relapsed or refractory LBCL.
- The approval is specifically for those ineligible for auto-HSCT or CAR T-cell therapy after two or more lines of systemic therapy.
- Data from the ECHELON-3 trial demonstrated a statistically significant improvement in overall survival with the brentuximab vedotin combination.
- Common adverse events included neutropenia, thrombocytopenia, anemia, and peripheral neuropathy, manageable with dose modifications.last yearBrentuximab Vedotin Triplet Shows Superior Outcomes in Relapsed/Refractory DLBCL- The ECHELON-3 study reveals that adding brentuximab vedotin to lenalidomide and rituximab significantly improves overall survival in relapsed/refractory DLBCL patients.
- The triplet therapy reduces the risk of disease progression or death by 47% compared to lenalidomide and rituximab alone, demonstrating a substantial PFS benefit.
- The objective response rate with the brentuximab vedotin triplet was 64.3%, significantly higher than the 41.5% achieved with the doublet.
- No new safety concerns arose with the addition of brentuximab vedotin, and adverse events were manageable with dose modifications.2 years agoBrentuximab Vedotin Triplet Shows Significant Survival Benefits in Relapsed/Refractory DLBCLInterim data from the phase 3 ECHELON-3 study presented at the 2024 ASCO Annual Meeting reveals that adding brentuximab vedotin to lenalidomide and rituximab significantly improves overall and progression-free survival in patients with relapsed/refractory diffuse large B-cell lymphoma, compared to the standard R2 regimen.2 years agoStudy on Brentuximab Vedotin Combination Therapy for Relapsed/Refractory DLBCL Shows Promising ResultsA recent study on the combination of Brentuximab Vedotin, lenalidomide, and rituximab for treating relapsed/refractory diffuse large B-cell lymphoma (DLBCL) has shown promising clinical activity, with a 70% overall response rate among patients. The study highlights the potential of this combination therapy for patients who have relapsed after or are ineligible for hematopoietic stem cell transplant or CAR-T therapy.4 years ago