NL-OMON56027招募中2 期
A PHASE II STUDY EVALUATING THE SAFETY AND EFFICACY OF GLOFITAMAB IN COMBINATION WITH RITUXIMAB (R) PLUS CYCLOPHOSPHAMIDE, DOXORUBICIN, VINCRISTINE, AND PREDNISONE (CHOP) IN CIRCULATING TUMOR (ct)DNA HIGH-RISK PATIENTS WITH UNTREATED DIFFUSE LARGE B-CELL LYMPHOMA - GO43075
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 2
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
- •Age 18 years or older at the time of signing Informed Consent Form
- •Previously untreated patients with CD20-positive DLBCL, including one of the
- •following diagnoses made according to the 2016 World Health Organization (WHO)
- •classification of lymphoid neoplasms
- •o DLBCL, not otherwise specified, including GCB and ABC/non-GCB types as well
- •as double-expressor lymphoma (coexpression of MYC and BCL2)
- •o High-grade B-cell lymphoma (HGBCL) with MYC and BCL2 and/or BCL6
- •translocations
- •o Patients with de novo transformed follicular lymphoma
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
- •International Prognostic Index (IPI): 1-5
- •Life expectancy of at least 6 months
- •Adequate biomarker blood samples prior to initiation of R-CHOP on Day 1 of
- •Cycle 1 and on Day 1 of Cycle 2 submitted for screening for determination of
- •ctDNA status
- •At least one bi-dimensionally fluorodeoxyglucose (FDG)-avid measurable
- •lymphoma lesion on positron emission tomography/computed tomography (PET/CT)
- •Left ventricular ejection fraction (LVEF) of at least 50%, as determined on
- •cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- •Negative HIV test at screening, with the following exception: Patients with a
- •positive HIV test at screening are eligible provided that, prior to enrollment,
- •they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4
- •count ³ 200/µL, have an undetectable viral load, and have not had a history of
- •an AIDS-defining opportunistic infection within the past 12 months.
- •Adequate hematopoietic function
- •Contraception use
- •Additional Inclusion Criterion for ctDNA High-Risk Participants
- •Plasma sample evaluated to be ctDNA high risk using the experimental AOA*NHL
- •Test,, defined as <2-log fold reduction in ctDNA levels between Day 1 of Cycle
- •1 and Day 1 of Cycle 2 by central laboratory assessment
排除标准
- •Current diagnosis of B-cell lymphoma, unclassifiable, with features
- •intermediate between DLBCL and classic Hodgkin lymphoma (gray-zone lymphoma),
- •primary mediastinal (thymic) large B-cell lymphoma, T-cell/histiocyte-rich
- •large B*cell lymphoma, Burkitt lymphoma, central nervous system (CNS) lymphoma
- •(primary or secondary involvement), primary effusion DLBCL, and primary
- •cutaneous DLBCL
- •Contraindication to any of the individual components of R-CHOP, including
- •prior receipt of anthracyclines, history of severe allergic or anaphylactic
- •reactions to murine monoclonal antibodies, or known sensitivity or allergy to
- •murine products
- •Prior treatment for indolent lymphoma
- •Prior solid organ or allogeneic stem cell transplant
- •Prior therapy for DLBCL and high-grade B-cell lymphoma (HGBCL) with the
- •exception of palliative, short-term treatment with corticosteroids
- •Pregnant or breastfeeding, or intending to become pregnant during the study
- •or within 12 months after the final dose of R-CHOP, 3 months after the final
- •dose of tocilizumab (if applicable), or 2 months after the final dose of
- •An exclusion criterion of a positive SARS-CoV-2 test within 7 days prior to
- •enrollment (including rapid antigen test) has been added
研究者
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