NCT05429268进行中（未招募）3 期
A Phase 3, Single-Arm, Open-Label, Multicenter Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 82
- 试验地点
- 122
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of of tafasitamab plus lenalidomide in adults with diffuse large B-cell lymphoma (DLBCL) who have relapsed or are refractory to at least 1 but no more than 3 previous systemic DLBCL treatment regimens and who are not eligible for high-dose chemotherapy (HDC) and autologous stem cell transplantation (ASCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed diagnosis of any of the following:
- •Diffuse large B-cell lymphoma not otherwise specified
- •T cell/histiocyte-rich large B-cell lymphoma
- •Epstein-Barr virus positive DLBCL of the elderly
- •Grade 3b follicular lymphoma
- •Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse
- •Evidence of histological transformation from an earlier diagnosis of low grade lymphoma (ie, an indolent pathology such as follicular lymphoma, marginal zone lymphoma, chronic lymphocytic leukemia) into DLBCL, with a subsequent DLBCL relapse
- •Willingness to undergo tumor biopsy requirements for the study, (or have archival lymph node or tissue block from the most recent biopsy, not to exceed 3 years prior to C1D1).
- •Willingness to undergo bone marrow biopsy/aspirate collections.
- •History of relapsed/progressive/recurrent disease according to the International Working Group response criteria after the most recent systemic therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Adequate hematologic, hepatic, and renal function,
- •Left ventricular ejection fraction (LVEF) ≥ 50%,
- •Willingness to avoid pregnancy or fathering children,
排除标准
- •Any other histological type of lymphoma according to the WHO 2016 classification of lymphoid neoplasms, including:
- •primary mediastinal (thymic) large B-cell lymphoma,
- •Burkitt lymphoma,
- •Primary refractory diffuse large B-cell lymphoma (DLBCL),
- •History of double- or triple-hit DLBCL.
- •Participants who, within 30 days prior to Cycle 1 Day 1, have:
- •Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy
- •Undergone major surgery or suffered from significant traumatic injury
- •Received live vaccines or have an anticipated need for such vaccination while receiving study treatment
- •Required parenteral antimicrobial therapy for active, intercurrent infections
- •Have undergone ASCT within the period ≤ 3 months prior to signing consent.
- •Have undergone previous allogenic stem cell transplantation.
- •Inadequate recovery (> Grade 1) from prior treatment toxicity and/or complications from major surgery before Cycle 1 Day
- •Have a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or are at high risk for a thromboembolic event in the opinion of the investigator and who are not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period.
- •Prior history of malignancies other than DLBCL, unless disease-free for ≥ 5 years prior to screening.
- •Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, New York Heart Association Class II to IV congestive heart failure, uncontrolled arrhythmia, and/or cardiac conduction issues, within 6 months of Cycle 1 Day
- •Any of the following positive tests:
- •Known seropositive for or history of active viral infection with HIV.
- •Known positive test result for hepatitis C (HCV antibody serology testing) and a positive test result for HCV RNA.
- •Known positive test results for chronic HBV infection (defined by HBsAg positivity). Participants with occult or prior HBV infection (defined as negative HBsAg and positive total HBcAb) may be included if HBV DNA was undetectable
研究组 & 干预措施
Tafasitamab and Lenalidomide
Experimental
Tafasitamab and lenalidomide will be coadministered for up to 12 cycles (28 days per cycle).followed by tafasitamab monotherapy (in participants with stable disease or better) until treatment withdrawal criteria are met.
干预措施: Tafasitamab (Drug)
Tafasitamab and Lenalidomide
Experimental
Tafasitamab and lenalidomide will be coadministered for up to 12 cycles (28 days per cycle).followed by tafasitamab monotherapy (in participants with stable disease or better) until treatment withdrawal criteria are met.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Approximately 24 months
Percentage of participants having best response of Complete Response (CR) or Partial Response (PR) as per Independent Review Committee and investigator's assessment.
次要结局
- Overall Survival (OS)(Approximately 24 months)
- Duration of Response (DOR)(Approximately 24 months)
- Progression Free Survial (PFS)(Approximately 24 months)
- Disease Control Rate (DCR)(Approximately 24 months)
- Time to Next Treatment (TTNT)(Approximately 24 months)
- Number of treatment-emergent adverse events(Approximately 24 months)
研究者
研究点 (122)
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