2023-503916-33-00招募中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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 277
- 试验地点
- 41
- 主要终点
- Progression-free survival (PFS) defined as the time between randomization and the first documentation of recurrence or progression by independent central review, or death from any cause
研究概览
简要总结
Evaluate the efficacy of loncastuximab tesirine combined with rituximab compared to standard immunochemotherapy compared to standard immunochemotherapy
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or female patient aged 18 years or older
- •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.
- •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
- •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
- •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
- •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
- •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.
- •ECOG performance status 0-2
- •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 equation Note: A laboratory assessment may be repeated a maximum of two times during the Screening period to confirm eligibility.
- •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 potential
排除标准
- •Previous treatment with loncastuximab tesirine
- •Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease
- •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
- •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
- •Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
- •History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- •Lymphoma with active CNS involvement, including leptomeningeal disease
- •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)
- •Breastfeeding or pregnant
- •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
- •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 Sponsor
- •Previous treatment with R-GemOx
- •Use of any other experimental medication within 14 days or 5 half- lives prior to start of study drug (Cycle 1 Day 1)
- •Received live vaccine within 4 weeks of Cycle 1 Day 1
- •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
- •Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)
- •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
- •Known history of hypersensitivity to oxaliplatin or other platinum- based drugs, or gemcitabine, or rituximab, or any of their excipients
- •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 to a CD19 antibody
- •Pathologic diagnosis of Burkitt lymphoma
- •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
- •Autologous transplant within 30 days prior to start of study drug (Cycle 1 Day 1)
- •Allogeneic transplant within 60 days prior to start of study drug (Cycle 1 Day 1)
- •Active graft-versus-host disease
- •Post-transplantation lymphoproliferative disorders
结局指标
主要结局
Progression-free survival (PFS) defined as the time between randomization and the first documentation of recurrence or progression by independent central review, or death from any cause
Progression-free survival (PFS) defined as the time between randomization and the first documentation of recurrence or progression by independent central review, or death from any cause
次要结局
未报告次要终点
研究者
ADC Therapeutics SA
Scientific
ADC Therapeutics S.A.
研究点 (41)
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