EUCTR2019-003983-28-IT进行中（未招募）1 期
A phase 2, multicenter, single-arm study of retreatment with brentuximab vedotin in subjects with relapsed or refractory classic Hodgkin lymphoma(cHL) or CD30-expressing peripheral T cell lymphoma (PTCL) -
适应症
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
- 80
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
- •- Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL.
- •- Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or
- •relapse after discontinuing treatment.
- •- Documentation of disease relapse or progression > o = 6 months after the last dose of brentuximab vedotin.
- •- Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis
- •as documented by radiographic technique.
- •- An Eastern Cooperative Oncology Group (ECOG) performance status < o = 2.
- •- Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and
- •for 6 months following last dose of study drug.
- •- Age 18 or older.
- •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 45
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •- Subjects who previously discontinued brentuximab vedotin due to any
- •Grade 3 or higher toxicity.
- •- Subjects with existing Grade 2 or higher peripheral neuropathy.
- •- Subjects who were previously refractory to treatment with brentuximab vedotin.
- •- Documented history of a cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms within 6 months prior to
- •their first dose of brentuximab vedotin.
- •- History of another malignancy within 3 years before the first dose of study drug or any evidence of residual disease from a previously
- •diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
- •- Subjects with acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis
- •agent against GvHD.
- •- Active cerebral/meningeal disease.
- •- History of progressive multifocal leukoencephalopathy (PML).
- •- Any active uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for AEs, NCI CTCAE Version
- •5.0) viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of brentuximab vedotin in this study.
- •- Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to
- •first dose of study drug, unless underlying disease has progressed on treatment.
- •- Subjects < 100 days from allogeneic transplant.
- •- Post-allogeneic transplant subjects with any detectable level of cytomegalovirus (CMV) by polymerase chain reaction (PCR).
- •- Prior donor lymphocyte infusion < 8 weeks prior to first dose of study drug.
- •Other protocol defined exclusion criteria may apply.
研究者
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