EUCTR2020-002686-33-DE进行中（未招募）1 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) - ECHELON-3
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Seagen Inc.
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 the most recent 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 subjects with transformed DLBCL (subtype k), 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:
- •1. One or more co-morbidities, including cardiac, pulmonary, renal or hepatic dysfunction that in the opinion of the Investigator make the subject medically unfit to received HSCT or CAR-T therapy
- •2. Active disease following induction and salvage chemotherapy
- •3.Inadequate stem cell mobilization (for HSCT)
- •4. Relapse following prior HSCT or CAR-T
- •5. 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 for the determination of CD30 expression.
- •- 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 > 1.5 cm by computed tomography (CT), as assessed by the site radiologist within 28 days of Day 1.
- •Other protocol defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 320
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
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. Subjects 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
- •- Participants who are breastfeeding
- •- Known hypersensitivity to any study drug or excipient contained in the drug formulation of the study drugs
- •- Any contraindication to associated study treatments.
- •- Known to be positive for hepatitis B by surface antigen expression.
- •Subjects who are hepatitis B core antigen (HBsAg) negative but hepatitis B surface antibody (HBcAb) positive are eligible, but should start hepatitis B prophylaxis therapy prior to receiving the first dose of
- •rituximab. Known to be positive for hepatitis C (HCV) infection (either
- •confirmed positive by polymerase chain reaction [PCR] or on antiviral
- •therapy for hepatitis C within the last 6 months). Participants who have been treated for hepatitis C infection are permitted if they have
- •documented sustained virologic response of 12 weeks.
- •- Participants with previous allogeneic HSCT if they meet either of the following criteria:
- •1.<100 days from HSCT
- •2.Active acute or chronic graft-versus-host disease (GVHD) or receiving immunosuppressive therapy as treatment for or prophylaxis against GVHD
- •- 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 1.
- •- 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, pulmonary
- •embolism, 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
- •Other protocol defined exclusion criteria may apply.
研究者
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