Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2025-12-24 @ 4:47 PM
NCT ID:
NCT07231250
Brief Summary:
This is a multi-center, phase II, prospective study. The main purpose of study is to evaluate the efficacy and safety of Glofitamab plus Polatuzumab vedotin and Zuberitamab in patients with newly diagnosed diffuse large B-cell lymphoma.
Detailed Description:
Nearly 1/3 of newly diagnosed DLBCL patients are over 75 years old, with a median age of 66. The number and proportion of patients unable to tolerate conventional immunochemotherapy continue to rise. Serious long-term toxicities associated with chemotherapy (e.g., reproductive effects, secondary malignancies) have created substantial clinical demand for first-line chemotherapy-free regimens. There is an urgent need for more clinical trials to explore the feasibility of chemo-free or chemo-light regimens in previously untreated DLBCL.
The Smart Stop study from MD Anderson is currently exploring chemotherapy-free, response-adapted therapy based on LTRA (Lymphoma Treatment Response Assessment) protocols. Meanwhile, the MOLTO study demonstrated that atezolizumab combined with venetoclax and obinutuzumab provides effective and well-tolerated treatment for previously untreated transformed DLBCL. This evidence above supports chemo-free or chemo-light regimens as a promising new direction for investigation in previously untreated DLBCL.
Early data suggest that Glofit + Pola-R-CHP in 1L DLBCL has promising efficacy and a similar safety profile to Pola-R-CHP and Glofit + R-CHOP.
This is a multi-center, phase II, prospective study. The main purpose of study is to evaluate the efficacy and safety of Glofitamab plus Polatuzumab vedotin and Zuberitamab in patients with newly diagnosed diffuse large B-cell lymphoma. After receiving 3 cycles of Glofitamab plus Polatuzumab vedotin and Zuberitamab（Anti-CD20 Monoclonal Antibody）, patients were treated with Glofitamab plus Polatuzumab vedotin and Zuberitamab for 5 cycles if CR or Glofitamab plus Polatuzumab vedotin and Zuberitamab-CHP for 6 cycles if PR/SD based on iPET status. The primary efficacy endpoint is CR rate at C4D1.
Study:
NCT07231250
Study Brief:
Protocol Section:
NCT07231250