EUCTR2015-001671-51-GB进行中（未招募）1 期
A RANDOMIZED, OPEN LABEL, PHASE 2 STUDY OF RITUXIMAB AND BENDAMUSTINE WITH OR WITHOUT BRENTUXIMAB VEDOTIN FOR RELAPSED OR REFRACTORY CD30-POSITIVE DIFFUSE LARGE B CELL LYMPHOMA
Seattle Genetics, Inc.0 个研究点目标入组 25 人开始时间: 2015年8月5日最近更新:
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
- 25
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
入选标准
- •1. Patients with histologically confirmed CD30-positive DLBCL or follicular non-Hodgkin lymphoma (NHL) grade 3b, defined as any detectable CD30 expression on tumor cells based on local or central pathologic assessment.
- •2. Patients must have relapsed or refractory disease following:
- •a. second-line or greater salvage systemic therapy, or
- •b. frontline cytotoxic systemic therapy, for patients who are ineligible for stem cell transplant (SCT).
- •3. Age 18 and older.
- •4. Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and measurable disease of at least 1.5 cm by computed tomography (CT), as assessed by the site radiologist.
- •5. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0–2.
- •6. The following baseline laboratory data:
- •a. Absolute neutrophil count (ANC) =1000/µL (unless documented bone marrow involvement)
- •b. Platelet count =75,000/µL (unless documented bone marrow involvement)
- •c. Serum bilirubin =1.5 × upper limit of normal (ULN) or =3 × ULN for patients with Gilbert’s disease
- •d. Estimated creatinine clearance (CrCL) =40 mL/min (calculated using the Cockcroft-Gault formula)
- •e. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 × ULN.
- •7. Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (ß-hCG) pregnancy test result within 7 days prior to the first dose of study drug.
- •Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or bilateral oophorectomy or hysterectomy.
- •8. Females of childbearing potential and males who have partners of childbearing potential must agree to use 2 effective contraceptive methods during the study and for 6 months following the last dose of brentuximab vedotin or 12 months following the last dose of rituximab, whichever is later.
- •Acceptable methods of contraception include: hormonal (birth control pills, injections, implants), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), vasectomy (for males), barrier methods (male and female condoms, diaphragms, and spermicides), and complete abstinence. Complete abstinence is acceptable when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception).
- •9. Patients must be willing and able to provide written informed consent.
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •1. History of another invasive malignancy that has not been in remission for at least 1 year. The following are exempt from the 1-year limit: nonmelanoma skin cancer, curatively treated localized prostate cancer, ductal carcinoma in situ (DCIS), and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear.
- •2. History of progressive multifocal leukoencephalopathy (PML).
- •3. Cerebral/meningeal disease related to the underlying malignancy. Patients with a history of cerebral/meningeal disease related to the underlying malignancy are allowed if prior central nervous system (CNS) disease has been definitively treated.
- •4. Any active Grade 3 or higher (per the National Cancer Institute [NCI, US] Common Terminology Criteria for Adverse Events [CTCAE] Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin. Routine antimicrobial prophylaxis is
- •5. Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug. Concomitant use of other systemic
- •antineoplastic agents (including bleomycin) while on study is excluded.
- •6. Females who are pregnant or breastfeeding.
- •7. Known hypersensitivity to any study drug or excipient contained in the drug formulation of any of the study drugs.
- •8. Known to be positive for hepatitis B by surface antigen expression (HBsAg) and hepatitis B core antibody (HBcAb). Known to have active hepatitis C infection (positive by polymerase chain reaction) or on antiviral therapy for hepatitis C within the last 6 months.
- •9. Known to be positive for human immunodeficiency virus (HIV).
- •10. Patients with previous allogeneic SCT.
- •11. Previous treatment with brentuximab vedotin or bendamustine.
- •12. Intolerable toxicity to prior rituximab therapy (per Investigator discretion).
- •13. Current therapy with other investigational agents.
- •14. Grade 3 or higher pulmonary disease unrelated to underlying malignancy.
- •15. Documented history of a cerebral vascular event (stroke or transient ischemic attack), unstable angina, myocardial infarction, or cardiac symptoms consistent with New York Heart Association
- •(NYHA) Class III-IV within 6 months prior to the first dose of brentuximab vedotin.
- •16. Congestive heart failure, Class III or IV, by the NYHA criteria.
- •17. Grade 2 or higher (per NCI CTCAE, Version 4.03) peripheral sensory or motor neuropathy at baseline.
- •18. Major surgery less than 30 days prior to first dose of study drug. Major surgery is any invasive operative procedure in which a more extensive resection is performed, eg, a body cavity is entered, organs are removed, or normal anatomy is altered.
- •19. Live vaccines (in particular yellow fever vaccination) within 1 month prior to the first dose of study drug.
- •20. Current severe immunodeficiency, or history of recurring or chronic infections, or underlying conditions which may further predispose patients to serious infection.
研究者
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