NL-OMON52039撤回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) - SGN35-031 - ECHELON-3
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Seagen Inc.
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
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:
- •o 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
- •o Active disease following induction and salvage chemotherapy
- •o Inadequate stem cell mobilization (for HSCT)
- •o Relapse following prior HSCT or CAR-T
- •o 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
- •- 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
- •Other protocol defined inclusion criteria may apply.
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 surface antigen (HBsAg) negative but hepatitis B
- •core 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
- •- 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 nonlymphomatous
- •- 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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