KCT0008884尚未招募Unknown
Phase 1/2 study of Selinexor in combination with dexamethasone, ifosfamide, carboplatin, etoposide chemotherapy in patients with secondary central nervous system involving relapsed or refractory B-cell non-Hodgkin lymphoma: a single arm, open label, multicenter study
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Subjects pathologically diagnosed with B-cell non-Hodgkin’s lymphoma who were treated with chemotherapy for remiss purposes and progressed or refractory to primary therapy and confirmed secondary central nervous system involvement.
- •2)Subjects whose age =19 years
- •3)Subjects with at least one measurable lesion of =1.0 cm in brain MRI
- •4)Proper functioning of bone marrow, kidneys, and liver
- •5)Healthy hepatitis B carriers can participate only if they can receive prophylactic antiviral treatment at the same time.
- •6)ECOG PS 0-2
- •7)Those who can take oral medication.
- •8)Subjects who have agreed to use an appropriate method of contraception in the case of women of childbearing potential and men. Appropriate methods of contraception are defined as intrauterine device (IUD), intrauterine system (IUS), bilateral tubal ligation, male partner’s vasectomy, and complete abstinence. In addition, male subjects should use barrier contraception such as condoms regardless of the permanent infertility state of the female partner. Appropriate methods of contraception are applied from the time of signing the consent form until at least 3 months after the last investigational product (IP) administration.)
排除标准
- •1)Primary CNS lymphoma
- •2)Burkitt lymphoma
- •3)Lymphoplasmacytic lymphoma
- •4)Symptomatic or uncontrolled angina and congestive heart failure, arrhythmia requiring medication (but participation is allowed if controlled by medication), subjects who are predicted to be at significant risk due to clinically significant myocardial infarction that occurred within 6 months prior to participation in this clinical trial
- •5)Occurrence of thrombosis or embolism within 6 months before the start of screening
- •6)Serious gastrointestinal bleeding exceeding grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 within 30 days prior to the start of screening
- •7)Ongoing infection exceeding grade 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 within 30 days prior to the start of screening
- •8)Chronic hepatitis accompanied by liver cirrhosis or HBV reactivation (but if hepatitis B surface antigen is positive but it is asymptomatic and does not require treatment, the patientsubject can be enrolled at the discretion of the investigator)
- •9)Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening (HBV surface antigen positive or HCV RNA positive if anti-HCV antibody positive at the screening test)
- •10)Those who cannot take oral medication
- •11)Subjects with a history of malignant tumors other than the target disease, except for the following cases
- •?Those who have not received treatment for the tumor for at least 3 years or who are disease-free
- •?At least 1 year has elapsed since complete resection of basal cell carcinoma/squamous cell carcinoma or successful treatment of cervical carcinoma in situ
- •12)Women who are pregnant, lactating or planning to become pregnant
- •13)Subjects with hypersensitivity reactions to the components of the investigational products to be provided (dexamethasone, ifosfamide, carboplatin, etoposide, selinexor) (e.g., subjects with angioedema, Stevens-Jones syndrome, toxic epidermal necrolysis, eosinophilia, or DRESS syndrome)
- •14)Subjects with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •15)Substance abuse, medical, mental, or social illness that may interfere with the subject’s participation in the clinical trial or evaluation of the clinical trial results
- •16)Subjects who cannot understand or comply with the instructions and requirements of the clinical trial or who have a history of non-compliance with medical therapy
- •17)Subjects who are concomitantly administrated other experimental drugs under clinical trials
- •18)Subjects with HIV seropositive
- •19)Major surgery within 28 days (except for lymph node or bone marrow biopsy)
- •20)Subjects with other serious illnesses or medical conditions as determined by the investigator
- •21)Subjects who were judged by the investigator to be unsuitable for participation in clinical trial other than the above exclusion criteria
研究者
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