NL-OMON53841尚未招募3 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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 10
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
- 18 至 99（—）
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. 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
- •6. 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.
- •7. ECOG performance status 0-2
- •8. 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 >=100000/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
- •Note: A laboratory assessment may be repeated a maximum of two times during the
- •Screening period to confirm eligibility.
- •9. Negative beta-human chorionic gonadotropin (β-hCG) pregnancy test within 7
- •days prior to start of study drug (Cycle 1 Day 1) for women of childbearing
- •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 12
- •months after the last dose of study treatment. Men with female partners who are
- •of childbearing potential must agree to use a condom when sexually active or
- •practice total abstinence from the time of giving informed consent until at
- •least 7 months after the patient receives his last dose of study treatment.
排除标准
- •1. Previous treatment with loncastuximab tesirine
- •2. Previous treatment with R-GemOx
- •3. Known history of hypersensitivity to a CD19 antibody, loncastuximab tesirine
- •(including SG3249) or any of its excipients, or history of or positive serum
- •human ADA 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
- •7. Allogeneic transplant within 60 days prior to start of study drug (Cycle 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 within 4 weeks prior to start of study drug (Cycle 1 Day 1);
- •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
- •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
- 另有 2 项未显示
研究者
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