NCT00606645已完成1 期
A Phase 1 Study of Every Other Week XmAb®2513 to Evaluate the Safety, Tolerability, and Pharmacokinetics in Patients With Hodgkin Lymphoma or Anaplastic Large Cell Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Xencor, Inc.
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- Identification of the maximum tolerated dose and identification of the recommended dose of XmAb®2513 for evaluation in future studies.
研究概览
简要总结
An open-label, multi-dose, single-arm, Phase 1 dose escalation study of XmAb®2513 was conducted to define the MTD or recommended dose(s) for further study, to determine safety and tolerability, to characterize PK and immunogenicity, and to evaluate antitumor activity of XmAb2513 in patients with HL and ALCL (non-cutaneous) and who have received two or more prior therapeutic regimens. There will be no intra-patient dose escalation.
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
- •Diagnosed with HL or ALCL.
- •Patients must have received two or more prior therapeutic regimens, one of which should include hematopoietic cell transplant, either autologous or allogeneic transplant.
- •If a hematopoietic cell transplant was refused, or the patient was not eligible to receive a transplant, the patient is still eligible to participate in the trial if the patient has received two or more prior chemotherapy based regimens.
- •Patients who have received allogeneic transplant must not have relapsed less than 6 months after their transplant and they must be at least 200 days post-transplant prior to enrollment, and with no evidence of GVHD
- •Patients should have at least one radiographically measurable site of disease of 1.5 cm in the largest dimension.
- •Patients must have completed all anti-cancer treatment > 4 weeks prior to enrollment.
- •Patients must have completed any palliative corticosteroid therapy (e.g. for management of Type B symptoms) > 2 weeks prior to enrollment.
- •Patients must be 18 years of age.
- •Required baseline laboratory data:
- •Platelet count 80,000/mm3 (patients must not be platelet transfusion-dependent as evidenced by maintenance of platelet count above 50,000/mm3 in the 28 days prior to enrollment without transfusion)
- •Absolute neutrophil count > 1,500/mm3
- •Creatinine ≤ 1.5 times ULN
- •ALT (SGPT) /AST (SGOT) ≤ 2.5 times upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 times ULN
- •Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
排除标准
- •Patients with known HL or ALCL involvement of either the leptomeningeal or central nervous system.
- •Patients requiring treatment with oral or intravenous corticosteroids or other oral or intravenous immunosuppressive agents.
- •Patients that have been designated Class III or IV by the New York Heart Association criteria.
- •Patients with a history of myocardial infarction or stroke within the last 6 months.
- •Patients with active infection are not eligible. This includes patients requiring anti-infective treatment during the 4 week period prior to enrollment. Patients on prophylactic anti-infective agents will be eligible provided they have no signs of active infection.
- •Patients who are known to be HIV, Hepatitis B, or Hepatitis C positive.
- •Patients with a history of prior malignancy other than HL or ALCL that have not been in remission for greater than 5 years, with the exception of basal or squamous skin carcinoma, cervical carcinoma in situ on biopsy, or localized prostate cancer (Gleason score < 5).
- •Patients who are pregnant or breastfeeding.
- •Patients with major surgery or radiation therapy within four weeks prior to enrollment.
结局指标
主要结局
Identification of the maximum tolerated dose and identification of the recommended dose of XmAb®2513 for evaluation in future studies.
时间窗: 1 year
次要结局
- Change in solCD30(1 year)
- Safety and tolerability(1 year)
- Assessment of immunogenicity(1 year)
- Objective response rate, disease control rate, and progression free survival.(1 year)
研究者
研究点 (8)
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