EUCTR2018-003727-10-GB进行中（未招募）1 期
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY EVALUATING THE SAFETY AND EFFICACY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB PLUS GEMCITABINE PLUS OXALIPLATIN (R-GEMOX) VERSUS R-GEMOX ALONE IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGEB-CELL LYMPHOMA
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
- 216
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
- •- Age >= 18 years
- •- Ability to comply with the study protocol, in the investigator’s judgment
- •- Histologically-confirmed DLBCL, not otherwise specified or history of transformation of indolent disease to DLBCL
- •- Relapsed or refractory disease
- •- At least one (>= 1) line of prior systemic therapy
- •- At least one bi-dimensionally measurable lesion
- •- Eastern Cooperative Oncology Group performance status of 0, 1 or 2
- •- Adequate hematological function
- •- For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs, women must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the treatment period and for 12 months after the final dose of pola or rituximab
- •- For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm, with a female partner of childbearing potential who is not pregnant, men who are not surgically sterile must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of < 1% per year during the treatment period and for 6 months after the final dose of oxand/or gem
- •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 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 108
排除标准
- •- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products
- •- Contraindication to R, gem or ox
- •- Peripheral neuropathy assessed to be > Grade 1 according to NCI CTCAE v5.0 at enrollment
- •- Prior use of pola or a gem + platinum-based agent combination
- •- Enrollment in any previous or ongoing pola trial
- •- Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to Cycle 1 Day 1
- •- Planned autologous or allogeneic stem cell transplantation at time of recruitment
- •- Primary or secondary central nervous system lymphoma at the time of recruitment
- •- Richter’s transformation or prior chronic lymphocytic leukemia
- •- Any of the following abnormal laboratory values, unless abnormal laboratory values are due to underlying lymphoma per the investigator:
- •o Creatinine > 1.5 x upper limit of normal (ULN) or a measured creatinine clearance < 30 mL/min
- •o Aspartate aminotransferase or alanine aminotransferase > 2.5 x ULN
- •o Total bilirubin >= 1.5 x ULN. Patients with documented Gilbert disease may be enrolled if total bilirubin is <= 3 x ULN
- •o International normalized ratio or prothrombin time > 1.5 x ULN in the absence of therapeutic anticoagulation
- •o Partial thromboplastin time or activated partial thromboplastin time > 1.5 x ULN in the absence of a lupus anticoagulant
- •- History of other malignancy that could affect compliance with the protocol or interpretation of results
- •- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease or significant pulmonary disease
- •- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to Cycle 1 Day 1
- •- Patients with suspected or latent tuberculosis
- •- Positive test results for chronic hepatitis B virus infection and hepatitis C virus antibody
- •- Known history of human immunodeficiency virus seropositive status
- •- Vaccination with a live vaccine within 4 weeks prior to treatment
- •- Recent major surgery (within 6 weeks before the start of Cycle 1 Day 1) other than for diagnosis
- •- Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
- •- Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 months after the last dose of study drug
研究者
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