EUCTR2013-000232-10-DE进行中（未招募）1 期
A Single-arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Hodgkin Lymphoma Who Are Not Suitable for Stem Cell Transplantation or Multiagent Chemotherapy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •- Male or female patients 18 years or older.
- •- A diagnosis of relapsed or refractory classical HL, confirmed by biopsy if clinically feasible on the basis of local pathology review.
- •- A history of at least 1 prior systemic chemotherapeutic regimen.
- •- Not suitable for SCT or multiagent chemotherapy.
- •- Bidimensional measurable disease, of at least 1.5 cm, as documented by radiographic technique (spiral CT scan preferred), per IWG Revised Response Criteria for Malignant Lymphoma.
- •- Patients must have completed any prior immunotherapy (eg, rituximab) or radioisotopic therapy at least 12 weeks before the first dose of brentuximab vedotin in the absence of clear disease progression.
- •- Patient has recovered to Grade 1 or lower toxicity related to radiotherapy, immunotherapy, and chemotherapy unless evidence of toxicity is due to underlying HL. If toxicity is related to underlying HL, Grade 2 or lower toxicity is acceptable
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Previous treatment with brentuximab vedotin.
- •2. Previously received an ASCT or alloSCT.
- •3. Female patients who are lactating and breastfeeding or have a positive serum or urine pregnancy test during the Screening period or a positive serum or urine pregnancy test on Day 1 before first dose of study drug.
- •4. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
- •5. Treatment with any investigational products within 4 weeks before the first dose of study drug.
- •6. Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
- •- New York Heart Association Class III or IV heart failure (refer to
- •Section 15.3)
- •- Myocardial infarction within 6 months before the first dose of study drug
- •- Evidence of current uncontrolled cardiovascular conditions, including
- •clinically relevant cardiac arrhythmias, congestive heart failure (CHF),
- •angina, or electrocardiographic evidence of acute ischemia or active
- •conduction system abnormalities
- •7. History of another primary malignancy that has not been in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
- •8. Any active uncontrolled systemic viral, bacterial, or fungal infection.
- •9. Any antimicrobial, antiviral, or antifungal therapy within 1 week prior to the first dose of brentuximab vedotin (routine prophylaxis is acceptable).
- •10. Known cerebral/meningeal disease, including signs or symptoms suggestive of PML, or any history of PML.
- •11. Known human immunodeficiency virus (HIV).
- •12. Known hepatitis B surface antigen positive, or known or suspected active hepatitis C infection.
- •13. Grade 2 or higher peripheral neuropathy.
- •14. Current therapy with other systemic antineoplastic or investigational agents.
- •15. Therapy with corticosteroids at higher than or equal to 20 mg/day of prednisone equivalent within 1 week before administration of the first dose of brentuximab vedotin.
- •16. Patients with a known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation.
- •17. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
研究者
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