Phase II study on the role of brentuximab vedotin as single agent in the treatment of relapsed/refractory CD30 positive peripheral T cell lymphoma (PTCL) patients

Fondazione Italiana Linfomi ONLUS0 个研究点目标入组 25 人开始时间: 2014年9月23日最近更新: 2018年2月26日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 25

研究概览入排标准研究者记录与标识符相似试验

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.Signed written informed consent.
•2.Males and females =18 years at the time of enrolment.
•3.Histologically confirmed diagnosis of PTCL (PTCL-not otherwise specified [PTCL-NOS], angioimmunoblastic T cell lymphoma [AILT] and transformed mycosis fungoides) according to World Health Organization (2008) classification.
•4.Histologically confirmed CD30+ PTCL.
•5.Availability of histological material for central review and pathobiological studies.
•6.Failed or intolerant of at least one prior systemic antilymphoma therapy.
•7.Eastern Cooperative Oncology Group (ECOG) performance status score of = 1 at study entry.
•8.At least one site of disease measurable in two dimensions by computed tomography. Both nodal and extranodal disease will be considered (lymphnodes must have long axis of 1.5 cm regardless of short axis or long axis 1.1 to 1.5 cm and short axis >1.0 cm).
•9.Hematology values within the following limits:
•oAbsolute neutrophil count (ANC) = 1500/mm3 independent of growth factor support.
•oPlatelets =75,000/mm3 or =50,000/mm3 if bone marrow involvement is independent of transfusion support.
•oHemoglobin level =8 g/dL.
•10.Biochemical values within the following limits:
•oAlanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 3 x upper limit of normal (ULN).
•oTotal bilirubin < 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin).
•oSerum creatinine = 2 x ULN.
•oSerum albumin = 3 g/dL.
•11.Women of childbearing potential (WOCBP) must have a negative pregnancy test within 7 days of receiving study medication.
•12.WOCBP must agree to use effective contraception, defined as oral contraceptives, double barrier method or practice true abstinence from sexual intercourse during the study and for 6 months after the last dose of study drug.
•13.Male subjects and their female partners of childbearing potential must be willing to use an appropriate method of contraception or practice true abstinence from sexual intercourse during the study and for 6 months after the last dose of study drug.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

排除标准

•1.Diagnosis of CTCL, ALCL, mycosis fungoides or Sezary Syndrome.
•2.CD30 expression < 10 % as measured by IHC
•3.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.
•4.Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin.
•5.Any serious active disease or co-morbid medical condition (according to investigator's decision).
•6.Prior history of malignancies other than lymphoma (except for a history of a complete resection for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) unless the subject has been free of the disease for = 3 years.
•7.Pre-existing peripheral neuropathy Grade =2.
•8.Signs or symptoms of progressive multifocal leukoencephalopathy (PML).
•9.Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
•10.Pregnant or lactating females or men or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study or a positive pregnancy test on Day 1 before first dose of study drug.
•11.CNS disease (meningeal and/or brain involvement by lymphoma) or testicular involvement
•12.History of clinically relevant liver or renal insufficiency; significant pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances.
•13.Known history of any of the following cardiovascular conditions
•oMyocardial infarction within 2 years from enrollment
•oNew York Heart Association (NYHA) Class III or IV heart failure
•oEvidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
•oRecent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
•14.Active opportunistic infection.
•15.Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C or active infection with Hepatitis B.
•16.Prior allogeneic stem cell transplant.

研究者

发起方

Fondazione Italiana Linfomi ONLUS

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