EUCTR2021-001647-28-PL进行中（未招募）1 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
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
- 40
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 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 (patients with discordant bone marrow involvement, i.e., evidence of low-grade histology in bone marrow) may be considered after discussion with the Medical Monitor
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0–2
- •International Prognostic Index (IPI): 1-5
- •Life expectancy of >=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) scan
- •Left ventricular ejection fraction (LVEF) >=50%, as determined on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- •Negative HIV test at screening, with the following exception:
- •o 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, and have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months
- •Adequate hematopoietic function
- •For patients enrolled in France:
- •- Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) polymerase chain reaction (PCR) testing within 48 hours before study
- •treatment administration at each treatment cycle
- •- Vaccination status in line with French National guidelines/recommendations [COSV, National Agency for AIDS Research
- •(ANRS), MIE]
- •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
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
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
- •Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable
- •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 glofitamab
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