ACTRN12619000581167招募中2 期
Efficacy of Positron Emission Tomography (PET) directed combination therapy with Brentuximab Vedotin and donor lymphocyte infusion in Hodgkin lymphoma relapsing or persisting after allogeneic haematopoietic stem cell transplantation
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Each participant must meet all the following criteria:
- •1. Age 18 years or older
- •2. Have a diagnosis of CD30+ Hodgkin lymphoma in any remission status
- •3. Undergoing or less than 60 days post-alloHCT from a matched related or unrelated adult donor
排除标准
- •Patients meeting any of the following exclusion criteria (at time of screening) are not to be enrolled in the study:
- •1. Prior exposure to brentuximab vedotin with less than PR or hypersensitivity reaction manifesting with anaphylaxis, Stevens-Johnson syndrome or toxic epidermal necrolysis or any adverse reaction attributed to brentuximab vedotin with severity greater than or equal to grade 2
- •2. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
- •3. Any sensory or motor peripheral neuropathy greater than or equal to grade 2
- •4. Known cerebral or meninteal disease (Hodgkin lymphoma or any other aetiology) including signs or symptoms of progressive multifocal leukoencephalopathy
- •5. Knwon hepatitis B surface antigen positive, or known or suspected actuve hepatitis C infection
- •6. Knwon human immunodeficiency virus (HIV) exposure
- •7. Diagnosed or treated for another malignancy within 3 years before the first dose or previoiusly diagnosed with anther malignancy and have evidence of residual disease
- •8. Known history of any of the following cardiovascular conditions: myocardial infarction within 2 years of registration; class III or IV heart failure; evidence of uncontrolled cardovascular conditions; left venticular ejection fraction <50%
- •9. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to the protocol
- •10. Paatients that have had prior chemotherapy or other investigational agents within 5 half-lives of the last dose of that treatment
- •11. Female patients who are both lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on day 1 before first dose of study drug
研究者
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