EUCTR2013-003934-33-IT进行中（未招募）1 期
A pilot phase II study with BRENTUXIMAB VEDOTIN as pre-ASCT induction therapy in relapsed/refractory Hodgkin’s lymphoma patients non responding to IGEV salvage treatment.
Fondazione Italiana Linfomi Onlus0 个研究点目标入组 13 人开始时间: 2014年6月26日最近更新:
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
- 入组人数
- 13
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
- •1. Classical Hodgkin Lymphoma according to the World Health
- •Organisation (WHO) classification
- •2. Histologically confirmed CD30+ HL at diagnosis
- •3. Patients at the first line salvage therapy
- •4. FDG-PET positivity after two cycles of IGEV treatment
- •5. PBPCs should have been collected after the first or the second IGEV
- •6. Age= 18 years
- •7. ECOG performance status of 0-2
- •8. Life expectancy > 6 months.
- •9. Written informed consent was obtained from the patient prior to any
- •study-specific screening procedures
- •10. Patients must be available for periodic blood sampling, study-related
- •assessments and management of toxicity at the treating institution
- •11. Females of childbearing potential must have a negative ß-HCG
- •pregnancy test result (pregnancy test should be performed at
- •screening an on day 1 of cycle 1 prior to brentuximab vedotin
- •treatment).
- •12. Female patient is either post-menopausal for at least 1 year before
- •the screening visit or surgically sterile or if of childbearing potential,
- •agree to practice 2 effective methods of contraception, at the same
- •time, from the time of signing the informed consent through 6 months
- •after the last dose of study drug, or agrees to completely abstain
- •from heterosexual intercourse.
- •13. Male patients, even if surgically sterilized, (i.e., status post
- •vasectomy) agree to practice effective barrier contraception during
- •the entire study period and through 6 months after the last dose of
- •study drug, or agrees to completely abstain from heterosexual
- •intercourse.
- •14. Required baseline laboratory data:
- •- Absolute neutrophil count = 1500/µl
- •- Platelet count = 75.000/ µl
- •- Haemoglobin must be = 8 g/dL
- •- Serum bilirubin = 1.5 times ULN
- •- Serum creatinine < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute.
- •- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 2.5 times ULN
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Peripheral neuropathy > Grade 1
- •2. Histologic diagnosis different from Hodgkin Lymphoma
- •3. First line treatment with BEACOPP
- •4. Compressive symptoms caused by the presence of Lymphoma
- •5. Patients who have been treated previously with any anti-CD30
- •6. Known hypersensitivity to any recombinant proteins, murine proteins,
- •or excipients contained in the brentuximab vedotin formulation.
- •7. Known human immunodeficiency virus (HIV) positive
- •8. Known hepatitis B surface antigen-positive, or known or suspected
- •active hepatitis C infection
- •9. Diagnosed or treated for another malignancy within 3 years before
- •the first dose or previously diagnosed with another malignancy and
- •have evidence of residual disease. Patients with nonmelanoma skin
- •cancer or carcinoma in situ of any type are not excluded if they have
- •undergone complete resection.
- •10. Patients with known history of any of the following cardiovascular
- •conditions :
- •Myocardial infarction within 2 years of randomization
- •New York Heart Association (NYHA) Class III or IV heart failure
- •(see Appendix E)
- •Evidence of current uncontrolled cardiovascular conditions,
- •including cardiac arrhythmias, congestive heart failure (CHF),
- •angina, or electrocardiographic evidence of acute ischemia or
- •active conduction system abnormalities
- •Recent evidence (within 6 months before first dose of study drug)
- •of a left-ventricular ejection fraction <50%
- •11. Patients with known active viral, bacterial, or fungal infection
- •requiring treatment with antimicrobial therapy within 2 weeks prior to
- •the first dose of brentuximab vedotin.
- •12. Patients with known active Grade 3 or higher viral, bacterial, or
- •fungal infection within 2 weeks prior to the first dose of brentuximab
- •13. Patients with known cerebral/meningeal disease (HL or any other
- •etiology), including signs or symptoms of Progressive Multifocal
- •Leukoencephalopathy (PML).
- •14. Any serious medical or psychiatric illness that could, in the
- •investigator's opinion, potentially interfere with the completion of
- •treatment according to protocol.
- •15. Symptomatic neurologic disease compromising normal activities of
- •daily living or requiring medications.
- •16. Patients who are pregnant, or lactating and breastfeeding.
- •17. Patients that have not completed any prior treatment chemotherapy
- •and/or other investigational agents within at least 5 half-lives of last
- •dose of that prior treatment.
研究者
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