Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With R… (NCT05429268) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND)
Bulgaria82 participantsStarted 2022-12-23
Plain-language summary
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).
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. primary mediastinal (thymic) large B-cell lymphoma,
✕. Burkitt lymphoma,
✕. Primary refractory diffuse large B-cell lymphoma (DLBCL),
✕. History of double- or triple-hit DLBCL.
✕. 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