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Efficacy and Safety of Sequential Autologous Hematopoietic Stem Cell Transplantation Combined With Tafasitamab, Lenalidomide, and Standard Immunochemotherapy for Relapsed/Refractory Diffuse Large B-cell Lymphoma
Sponsor: The First Affiliated Hospital of Soochow University
Summary
This study aims to evaluate the efficacy and safety of tafasitamab combined with lenalidomide plus standard immunochemotherapy, followed by sequential autologous stem cell transplantation (ASCT), in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).
Official title: Efficacy and Safety of Sequential Autologous Hematopoietic Stem Cell Transplantation Combined With Tafasitamab, Lenalidomide, and Standard Immunochemotherapy for Relapsed/Refractory Diffuse Large B-cell Lymphoma, Prospective Phase II Clinical Study
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
25
Start Date
2026-01-01
Completion Date
2028-12-31
Last Updated
2026-06-02
Healthy Volunteers
No
Interventions
Treatment with the Tafa+Len+ standard immunotherapy regimen (e.g., R-ICE, R-DHAP, R-GDP, etc.)
Eligible patients with transplant-eligible relapsed/refractory DLBCL will receive 2-4 cycles (21 days per cycle) of tafasitamab combined with lenalidomide and standard immunochemotherapy regimens (such as R-ICE, R-DHAP, R-GDP, etc.). If the patient achieves a complete response (CR) or partial response (PR) on efficacy assessment, they will proceed to autologous stem cell transplantation (ASCT). Following ASCT, eligible patients may receive maintenance therapy with tafasitamab ± lenalidomide (28 days per cycle) for up to one year.
Locations (1)
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China