EUCTR2020-000241-14-IT进行中（未招募）1 期
A Phase 3 Randomized Study of Loncastuximab Tesirine Combined with Rituximab Versus Immunochemotherapy in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL) (LOTIS-5) - Loncastuximab Tesirine in Combination with Rituximab
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
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 World Health Organization classification (including patients with DLBCL transformed from indolent lymphoma), or high-grade B cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
- •3. Relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) disease following at least one multi-agent systemic treatment regimen
- •4. Not considered by the investigator to be a candidate for stem cell transplantation based on performance status, advanced age, and/or significant medical comorbidities such as organ dysfunction
- •5. Patients who have received previous CD19-directed therapy must have a biopsy which shows CD19 expression after completion of the CD19-directed therapy
- •6. Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET) – computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if tumor is not fluorodeoxyglucose (FDG)-avid on screening PET-CT
- •7. Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block (or minimum 10 freshly cut unstained slides if block is not available)
- •Note: Any biopsy since initial diagnosis is acceptable, but if several samples are available, the most recent sample is preferred.
- •8. ECOG performance status 0-2
- •9. Adequate organ function as defined by screening laboratory values within the following parameters:
- •a. Absolute neutrophil count =1000/µL (off growth factors at least 72 hours)
- •b. Platelet count =75000/µL without transfusion within the past 2 weeks
- •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. Calculated creatinine clearance =30 mL/min by the Cockcroft and Gault equation
- •Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility.
- •10. Negative beta-human chorionic gonadotropin (ß-hCG) pregnancy test within 7 days prior to start of study drug (Cycle 1 Day 1) for women of childbearing potential
- •11. Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9 months 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 6 months 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 157
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 193
排除标准
- •1. Previous treatment with loncastuximab tesirine
- •2. Previous treatment with R-GemOx
- •3. Known history of hypersensitivity to or positive serum human ADA to a CD19 antibody
- •4. Pathologic diagnosis of Burkitt lymphoma
- •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 transplant within 30 days prior to start of study drug (Cycle 1 Day 1)
- •7. Allogeneic transplant within 60 days prior to start of study drug (Cycle 1 Day 1)
- •8. Active graft-versus-host disease
- •9. Post-transplantation lymphoproliferative disorders
- •10. Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease
- •11. Human immunodeficiency virus (HIV) seropositive with any of the following:
- •a. CD4+ T-cell (CD4+) counts <350 cells/µL
- •b. Acquired immunodeficiency syndrome-defining opportunistic infection within 12 months prior to screening
- •c. Not on anti-retroviral therapy, or on anti-retroviral therapy for <4 weeks at the time of screening
- •d. HIV viral load =400 copies/mL
- •12. Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
- •13. Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
- •14. History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- •15. Lymphoma with active CNS involvement, including leptomeningeal disease
- •16. 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)
- •17. Breastfeeding or pregnant
- •18. Uncontrolled hypertension (blood pressure =160/100 mm Hg 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, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient’s ability to tolerate the study treatment
- •19. Major surgery, radiotherapy, chemotherapy or other antineoplastic therapy within 14 days prior to start of study drug (Cycle 1 Day 1), except shorter if approved by the Sponsor
- •20. Use of any other experimental medication within 14 days or 5 half-lives prior to start of study drug (Cycle 1 Day 1)
- •21. Received live vaccine within 4 weeks of Cycle 1 Day 1
- •22. Failure to recover to =Grade 1 (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) from acute non hematologic toxicity (except alopecia) due to previous therapy prior to screening
- •23. Congenital long QT syndrome or a corrected QTcF interval of =480 ms at screening (unless secondary to pacemaker or bundle branch block)
- •24. Any other significant medical illness, abnormality, or condition that would, in the Investigator’s judgment, make the patient inappropriate for study participation or put the patient at risk
- •25. Known history of hypersensitivity to oxaliplatin or any of its excipients
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