A new study will evaluate the real-world efficacy of tafasitamab combined with a lenalidomide base regimen in patients with relapsed or refractory diffuse large B-cell lymphoma  (R/R DLBCL). The trial is expected to start on July 1, 2023 and will include 15 participants previously diagnosed with R/R DLBCL after systemic therapy.

The participants, previously treated with tafasitamab, will be divided into 2 groups, with group 1 being the combination therapy group, where patients will receive tafasitamab combined with lenalidomide, lenalidomide plus BTK inhibitors, and lenalidomide plus chemotherapy.

Read more about DLBCL therapies

The group 2 will be the tafasitamab combination therapy group, where participants will receive tafasitamab combination therapy followed by sequential CAR T or transplantation. Furthermore, both group participants will receive tafasitamab Injection as part of their treatment.

The primary outcome measure is the objective remission rate at the end of cycle 2 as defined as the proportion of patients with complete response and partial response. Of note, each cycle consists of 28 days. The secondary outcome includes progression-free survival and the time between the start of treatment and tumor progression or death of the patient. 

The trial will be conducted at the Shanghai Jiao Tong University School of Medicine in Shanghai, China, and is expected to be completed by December 30, 2024. 

DLBCL is an aggressive, common, and fast-growing type of nonHodgkin’s lymphoma, with an estimated 30,400 cases in the United States in 2022 and 150,000 new cases each year globally. Patients with DLBCL are generally treated with chemoimmunotherapy-based regimens, while several targeted therapies, such as T-cell mediated treatments, have recently emerged for patients with R/R DLBCL. However, single-agent and readily accessible treatment options are limited.


A real-world study of tafasitamab in combination with lenalidomide in patients with R/R DLBCL. ClinicalsTrials.gov. Updated June 1, 2023. Accessed June 27, 2023.