EUCTR2021-006049-36-CZ进行中（未招募）1 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 - firmMIND
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
- 81
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
- 性别
- All
入选标准
- •* Men and women 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
- •* Disease history that meets the following criteria:
- •a. Relapsed/progressive/recurrent disease, defined as the appearance of any new lesions or increase by = 50% of previously involved sites from nadir according to the International Working Group response criteria after the most recent systemic therapy.
- •Refractory disease, defined as having had less than a PR to the most recently administered systemic therapy.
- •b. At least one bidimensionally measurable disease site. The lesion must have a greatest transverse diameter of = 1.5 cm and greatest perpendicular diameter of = 1.0 cm at baseline, and must be positive on PET scan.
- •c. Received at least 1, but no more than 3 previous systemic regimens for the treatment of DLBCL. One line of therapy must have included an anti-CD20-targeted therapy.
- •d. Disease which is not amenable to intensive salvage therapy including ASCT due to pre-existing comorbidities or participant refusal. Documentation of the reason must be provided in the patient's source data.
- •For the full list of inclusion criteria, please refer to the study protocol
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 71
排除标准
- •* Women who are pregnant or breastfeeding.
- •* 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)
- •*Previous allogenic stem cell transplantation
- •For the full list of exclusion criteria, please refer to the study protocol
研究者
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