EUCTR2017-004288-11-GB进行中（未招募）1 期
A Phase 2 Open-Label Single-Arm Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 140
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. Male or female patient aged 18 years or older
- •2. Pathologic diagnosis of DLBCL, as defined by the 2016 WHO classification, to include: DLBCL not otherwise specified; primary mediastinal large B-cell lymphoma; and high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
- •3. Relapsed or refractory disease following two or more multi-agent systemic treatment regimens
- •4. Patients who have received previous CD19-directed therapy must have a biopsy that shows CD19 protein expression after completion of the CD19-directed therapy
- •5. Measurable disease as defined by the 2014 Lugano Classification
- •6. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available)
- •7. ECOG performance status 0-2
- •8. Adequate organ function as defined by screening laboratory values within the following parameters:
- •a. Absolute neutrophil count (ANC) =1.0 × 10^3/µL (off growth factors at least 72 hours)
- •b. Platelet count =75 × 10^3/µL without transfusion in the prior 7 days
- •c. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) =2.5 × the upper limit of normal (ULN)
- •d. Total bilirubin =1.5 × ULN (patients with known Gilbert’s syndrome may have a total bilirubin up to =3 × ULN)
- •e. Blood creatinine =1.5 × ULN or calculated creatinine clearance =60 mL/min by the Cockcroft and Gault equation
- •9. Negative beta-human chorionic gonadotropin (ß-HCG) pregnancy test within 7 days prior to start of study drug (C1D1) for women of childbearing potential
- •10. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of loncastuximab tesirine
- •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 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 98
排除标准
- •1. Previous treatment with loncastuximab tesirine
- •2. Known history of hypersensitivity to or positive serum human ADA
- •to a CD19 antibody
- •3. Pathologic diagnosis of Burkitt lymphoma
- •4. Bulky disease, defined as any tumor =10 cm in longest dimension
- •5. Active second primary malignancy other than non-melanoma skin
- •cancers, non-metastatic prostate cancer, in situ cervical cancer,
- •ductal or lobular carcinoma in situ of the breast, or other malignancy
- •that the Sponsor’s medical monitor and Investigator agree and
- •document should not be exclusionary
- •6. Autologous stem cell transplant within 30 days prior to start of study
- •drug (C1D1)
- •7. Allogeneic stem cell transplant within 60 days prior to start of study
- •drug (C1D1)
- •8. Active graft-versus-host disease
- •9. Post-transplant lymphoproliferative disorders
- •10. Active autoimmune disease, including motor neuropathy considered
- •of autoimmune origin and other central nervous system (CNS)
- •autoimmune disease
- •11. Known seropositive and requiring anti-viral therapy for human
- •immunodeficiency virus (HIV), hepatitis B virus (HBV), or
- •hepatitis C virus (HCV). Note: Testing is not mandatory to be
- •12. History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- •13. Lymphoma with active CNS involvement at the time of screening,
- •including leptomeningeal disease
- •14. Clinically significant third space fluid accumulation
- •(i.e., ascites requiring drainage or pleural effusion that is either
- •requiring drainage or associated with shortness of breath)
- •15. Breastfeeding or pregnant
- •16. Significant medical comorbidities, including but not limited to,
- •uncontrolled hypertension (blood pressure [BP] =160/100 mmHg
- •repeatedly), unstable angina, congestive heart failure (greater than
- •New York Heart Association class II), electrocardiographic evidence
- •of acute ischemia, coronary angioplasty or myocardial infarction
- •within 6 months prior to screening, uncontrolled atrial or ventricular
- •cardiac arrhythmia, poorly controlled diabetes, or severe chronic
- •pulmonary disease
- •17. Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic
- •therapy within 14 days prior to start of study drug (C1D1), except
- •shorter if approved by the Sponsor
- •18. Use of any other experimental medication within 14 days prior to
- •start of study drug (C1D1)
- •19. Planned live vaccine administration after starting study drug (C1D1)
- •20. Failure to recover to Grade =1 (Common Terminology Criteria for
- •Adverse Events [CTCAE] version 4.0) from acute non-hematologictoxicity toxicity (Grade =2 neuropathy or alopecia) due to previous therapy prior to screening
- •21. Congenital long QT syndrome or a corrected QTcF interval of
- •>480 ms at screening (unless secondary to pacemaker or bundle
- •branch block)
- •22. Any other significant medical illness, abnormality, or condition that
- •would, in the Investigator’s judgment, make the patient
- 另有 1 项未显示
研究者
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