Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting.
详细描述
This phase 2 exploratory study will evaluate the clinical response of brentuximab vedotin in MF and SS, where tumor cells express variable levels of CD30 target molecule.
The primary objective is to explore the biologic activity of brentuximab vedotin in patients with MF and SS, the most common types of cutaneous T-cell lymphoma (CTCL), where expression of CD30 is variable. Brentuximab vedotin has significant biologic activity in Hodgkin's disease (HD) where only a small numbers of CD30 positive tumor cells are present, as well as in lymphomas with large numbers of CD30-expressing tumor cells such as systemic anaplastic large cell lymphoma (sALCL). The subject grouping by CD30 expression levels (low, intermediate, high) is for accrual purposes only, to ensure that a wide range of CD30 expression is studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Biopsy-proven MF/SS, stage IB-IVB, and failed one standard systemic therapy. Skin biopsy must be within 3 months of beginning study medication
- •At least the following wash-out from prior treatments:
- •≥ 3 weeks for local radiation therapy, systemic cytotoxic anticancer therapy, treatment with other anti-cancer investigational agents (including monoclonal antibody)
- •> 3 weeks for retinoids, interferons, vorinostat, romidepsin, denileukin diftitox and phototherapy
- •> 2 wks for topical therapy (including topical steroid, retinoid, nitrogen mustard, or imiquimod)
- •At least 18 years of age
- •ECOG performance status of ≤ 2
- •Must be able to commit to study schedule
- •Absolute neutrophil count (ANC) ≥ 1000/uL
- •Platelets ≥ 50,000/uL
- •Bilirubin ≤ 2X upper limit of normal (ULN) (EXCEPTION: Gilbert's disease ≤ 3X ULN)
- •Serum creatinine ≤ 2X ULN
- •Alanine aminotransferase (ALT) ≤ 3X ULN
- •Aspartate aminotransferase (AST) ≤ 3X ULN
- •Negative serum beta-HCG pregnancy test result within 7 days of first treatment, if a woman of childbearing potential
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Mycosis fungoides (MF) with limited disease (stage IA) or central nervous system (CNS) disease
- •Systemic or topical concomitant corticosteroid use for treatment of skin disease (EXCEPTION: Oral prednisone allowed at ≤ 10 mg/day)
- •Known Grade 3 or higher (per NCI CTCAE v4.0 criteria) active systemic or cutaneous viral, bacterial, or fungal infection
- •Known to be Hepatitis B or Hepatitis C antibody positive
- •HIV-positive with have a measurable viral load while on antiretroviral medication
- •Known hypersensitivity to recombinant proteins or any excipient contained in the drug formulation.
- •History of other malignancies during the past 3 years (EXCEPTIONS: non-melanoma skin cancer; curatively treated localized prostate cancer; curatively treated localized breast cancer; resected thyroid cancer; cervical intraepithelial neoplasia; or cervical carcinoma in situ on biopsy).
- •Breastfeeding
- •Congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria.
- •Any serious underlying medical condition that would impair subject's ability to receive or tolerate the planned treatment.
- •Dementia or altered mental status that would preclude subject's understanding and rendering of informed consent.
研究组 & 干预措施
Brentuximab vedotin
Novel antibody-drug conjugate, 1.8 mg/kg intravenously every 3 weeks
干预措施: Brentuximab vedotin (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 2 years
Overall response rate of brentuximab vedotin in this study population.
次要结局
- Overall Partial Response Rate(2 years)
- Overall Stable Disease Rate(2 years)
- Overall Non-Evaluable Response(4 weeks)
研究者
Youn Kim
The Joanne and Peter Haas, Jr, Professor for Cutaneous Lymphoma Research
Stanford University