A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Brentuximab Vedotin and CHP (A+CHP) Versus CHOP in the Frontline Treatment of Patients With CD30-positive Mature T-cell Lymphomas
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Seagen Inc.
- 入组人数
- 452
- 试验地点
- 144
- 主要终点
- Progression-free Survival Per Independent Review Facility (IRF)
研究概览
简要总结
This is a double-blind, randomized, multicenter, phase 3 clinical trial to compare the efficacy and safety of brentuximab vedotin in combination with CHP with the standard-of-care CHOP in patients with CD30-positive mature T-cell lymphomas.
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
- Double (Participant, 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
- •Patients with newly diagnosed, CD30-positive mature T-cell lymphomas
- •Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT
- •Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
排除标准
- •History of another primary invasive malignancy that has not been in remission for at least 3 years
- •Current diagnosis of primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides
- •History of progressive multifocal leukoencephalopathy (PML)
- •Cerebral/meningeal disease related to the underlying malignancy
研究组 & 干预措施
CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
干预措施: doxorubicin (Drug)
CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
干预措施: prednisone (Drug)
CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
干预措施: vincristine (Drug)
CHOP
cyclophosphamide, doxorubicin, vincristine, and prednisone
干预措施: cyclophosphamide (Drug)
A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
干预措施: brentuximab vedotin (Drug)
A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
干预措施: doxorubicin (Drug)
A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
干预措施: prednisone (Drug)
A+CHP
brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone
干预措施: cyclophosphamide (Drug)
结局指标
主要结局
Progression-free Survival Per Independent Review Facility (IRF)
时间窗: Up to 60 months
The time from the date of randomization to the date of first documentation of progressive disease (PD), death due to any cause, or receipt of subsequent anticancer chemotherapy to treat residual or progressive disease whichever occurred first.
次要结局
- Progression-free Survival Per IRF in Patients With Systemic Anaplastic Large Cell Lymphoma (sALCL)(Up to 60 months)
- Complete Remission (CR) Rate Per IRF at End of Treatment (EOT)(Up to 8.34 months)
- Overall Survival (OS)(Up to 90 months)
- Objective Response Rate (ORR) Per IRF at End of Treatment(Up to 8.34 months)
- Incidence of Adverse Events (AEs)(Up to 8.28 months)
- Incidence of Laboratory Abnormalities(Up to 8.28 months)