Phase II Study Comparing Rocbrutinib Alone to Investigators Choice Therapy in Adults With Relapsed or Refractory Non-GCB Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigators choice of BRR2 regimen in patients with relapsed or refractory non-germinal center B-cell-like non-GCB diffuse large B-cell lymphoma DLBCL. This open-label, randomized controlled Phase II clinical study aims to provide new treatment options for patients who have experienced relapse or resistance after prior therapies, including at least one anti-CD20 antibody-containing regimen. Participants are randomly assigned to receive either Rocbrutinib at 200 mg orally once daily until disease progression or unacceptable toxicity, or the investigators choice of combination therapy consisting of Bendamustine and Rituximab BR or Rituximab plus Lenalidomide R2. The BR regimen involves six 28-day cycles of Bendamustine 90 mgm2 IV infusion on Days 1 and 2 and Rituximab 375 mgm2 IV infusion on Day 1 of each cycle, while the R2 regimen includes Rituximab with Lenalidomide at 20 mg orally on Days 1 to 21 of each cycle. Participants will undergo regular assessments including evaluations of overall response rate, complete remission rate, progression-free survival, overall survival, duration and time to response, and safety monitoring up to 24 months, with some outcomes followed for up to five years. Safety is assessed from the first dose until 28 days after the last dose. The total participation duration depends on treatment response and follow-up schedules, with careful monitoring throughout the study to track treatment effects and adverse events.

A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma