2023-505579-53-00招募中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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Incyte Corp.
- 入组人数
- 74
- 试验地点
- 39
- 主要终点
- ORR (overall response rate), defined as the percentage of participants having best response of CR or PR as per IRC assessment.
研究概览
简要总结
To determine the efficacy of tafasitamab plus lenalidomide in study participants with R/R DLBCL who are not eligible for HDC/ASCT, using the 2014 Lugano Classification.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Treatment of adults with R/R DLBCL who are not eligible for HDC and ASCT.
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Aged ≥ 18 years at the time of consent.
- •Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures.
- •Histologically-confirmed diagnosis of any of the following: a. Diffuse large B-cell lymphoma not otherwise specified b. T cell/histiocyte-rich large B-cell lymphoma c. Epstein-Barr virus positive DLBCL of the elderly d. Grade 3b follicular lymphoma e. Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse f. 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, including an incisional, excisional, or core needle lymph node or tissue biopsy (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 as appropriate. Please refer to protocol for a complete list of inclusion criteria.
排除标准
- •Any other histological type of lymphoma according to the WHO 2016 classification of lymphoid neoplasms, including: a. primary mediastinal (thymic) large B-cell lymphoma b. Burkitt lymphoma c. Primary refractory DLBCL, defined as disease progressing in the course of the first line treatment, and/or showing a response of less than a PR to first-line treatment, or disease recurrence/progression within < 6 months from the completion of first-line therapy. d. History of double- or triple-hit DLBCL, characterized by simultaneous detection of MYC with BCL2 and/or BCL6 translocation(s) as per fluorescence in situ hybridization. MYC, BCL2, BCL6 testing prior to study enrollment is not required.
- •History or evidence of CNS lymphoma (primary and secondary).
- •Prior treatment with CD19-targeted therapy or IMiDs (eg, thalidomide, lenalidomide)
- •Participants who, within 30 days prior to Cycle 1 Day 1, have: a. Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma-specific therapy b. Undergone major surgery or suffered from significant traumatic injury c. Received live vaccines or have an anticipated need for such vaccination while receiving study treatment d. Required parenteral antimicrobial therapy for active, intercurrent infections
- •Have undergone ASCT within the period ≤ 3 months prior to signing consent. If an ASCT was performed > 3 months prior to signing consent, full hematological recovery must be demonstrated before enrollment into the study. Please refer to protocol for a complete list of exclusion criteria.
结局指标
主要结局
ORR (overall response rate), defined as the percentage of participants having best response of CR or PR as per IRC assessment.
ORR (overall response rate), defined as the percentage of participants having best response of CR or PR as per IRC assessment.
次要结局
- • DOR (Duration of Response), defined as time from 1st documented CR (complete response) or PR (partial response) until the date of 1st documented disease progression or death due to any cause, whichever occurs first, among participants who achieve CR or PR per IRC (independent review committee) assessment. Refer protocol for complete list.
研究者
Clinical Trial Information
Scientific
Incyte Corp.
研究点 (39)
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