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ACTIVE NOT RECRUITING
NCT07621406
PHASE2

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

View on ClinicalTrials.gov

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

DRUG

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