Phase II Study of Glofitamab and Chidamide Combination Therapy for Adults with Recurrent or Refractory Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the feasibility, effectiveness, and safety of combining Glofitamab with chidamide in adults aged 18 and older who have recurrent or refractory diffuse large B-cell lymphoma DLBCL. This phase II, open-label, single-arm study is conducted at a single center and aims to provide new treatment insight for this type of lymphoma. Participants will receive combination therapy including Glofitamab and chidamide. Glofitamab is given by injection with a step-dose escalation starting with 2.5 mg on day 8 and 10 mg on day 15 in the first 28-day cycle, then 30 mg every 3 weeks from cycle 2 through cycle 12. Chidamide is taken orally twice a week at 20 mg per dose for 21 days per treatment cycle. The study includes screening, treatment, and follow-up phases. During the study, participants will be closely monitored through various assessments to evaluate response and safety. Researchers will measure the complete response rate up to the end of 12 treatment cycles, along with overall response rate, duration of response, progression-free survival, and overall survival over a two-year period. Participants will undergo regular clinical evaluations and follow-ups to monitor treatment outcomes and any side effects. The total participation may last up to several years due to extended follow-up monitoring.

Glofitamab Combination With Chidamide in Patients With Recurrent/Refractory DLBCL