EUCTR2017-002023-21-PT进行中（未招募）1 期
A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL COMPARING THE EFFICACY AND SAFETY OF POLATUZUMAB VEDOTIN IN COMBINATION WITH RITUXIMAB AND CHP (R-CHP) VERSUS RITUXIMAB AND CHOP (R-CHOP) IN PREVIOUSLY UNTREATED PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA - POLARIX
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
- 875
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
入选标准
- •- Age 18-80 years
- •- Previously untreated patients with CD20-positive DLBCL, including one of the following diagnoses by 2016 WHO classification of lymphoid neoplasms:
- •o DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B-cell type
- •o T-cell/histiocyte-rich large B-cell lymphoma
- •o Epstein-Barr virus-positive DLBCL, NOS
- •o ALK-positive large B-cell lymphoma
- •o HHV8-positive DLBCL, NOS
- •o High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma)
- •o High-grade B-cell lymphoma, NOS
- •- Availability of archival or freshly collected tumor tissue before study enrollment
- •- International Prognostic Index score of 2-5
- •- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- •- Life expectancy >= 12 months
- •- At least one bi-dimensionally measurable lesion, defined as >= 1.5 cm in its longest dimension as measured by computed tomography or magnetic resonance imaging
- •- Ability and willingness to comply with the study protocol procedures, including patient reported outcome measures
- •- Left ventricular ejection fraction >= 50% on cardiac multiple-gated acquisition scan or cardiac echocardiogram
- •- Adequate hematologic function
- •- For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 12 months after the last dose of study treatment
- •- For women of childbearing potential, a negative serum pregnancy test result within 7 days prior to commencement of dosing
- •- For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm for at least 5 months after the last dose of blinded polatuzumab vedotin/placebo, 3 months after the last dose of rituximab, and for at least 6 months after the last dose of blinded vincristine/placebo and cyclophosphamide to avoid exposing the embryo for the duration of the pregnancy
- •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 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 525
排除标准
- •- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
- •- Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
- •- Prior organ transplantation
- •- Current Grade >1 peripheral neuropathy by clinical examination
- •- Demyelinating form of Charcot-Marie-Tooth disease
- •- History of indolent lymphoma
- •- Follicular lymphoma grade 3B
- •- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey-zone lymphoma)
- •- Primary mediastinal (thymic) large B-cell lymphoma
- •- Burkitt lymphoma
- •- Prior treatment with cytotoxic drugs within 5 years of screening for any condition or prior use of any anti-CD20 antibody
- •- Prior use of any monoclonal antibody within 3 months of the start of Cycle 1
- •- Prior therapy for DLBCL, with the exception of nodal biopsy
- •- Corticosteroid use >30 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
- •- Patients with CNS lymphoma, primary effusion DLBCL, and primary cutaneous DLBCL
- •- Vaccination with live vaccines and any investigational therapy within 28 days prior to the start of Cycle 1
- •- 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
- •- Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
- •- History or presence of an abnormal electrocardiogram that is clinically significant in the investigator’s opinion
- •- Known active bacterial, viral, fungal, mycobacterial, parasitic or other infection at study enrollment or significant infections within 2 weeks before the start of Cycle 1
- •- Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
- •- Prior radiotherapy to the mediastinal/pericardial region
- •- Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator’s judgment
- •- Any of the abnormal laboratory values such as international normalization ratio > 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation, Partial thromboplastin time or activated partial thromboplastin time > 1.5 x ULN in the absence of a lupus anticoagulant, Serum aspartate aminotransferase and alanine aminotransferase >= 2.5 x ULN, Total bilirubin >= 1.5 x ULN, Serum creatinine clearance < 40 mL/min
- •- Patients with suspected active or latent tuberculosis
- •- Positive test results for chronic hepatitis B infection, hepatitis C, human T-lymphotrophic 1 virus
- •- Known history of HIV seropositive status
- •- Patients with a history of progressive multifocal leukoencephalopathy
- •- Pregnancy or lactation or intending to become pregnant during stud
研究者
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