NCT07189065

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

An Open-Label, Randomized Controlled, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Rocbrutinib Monotherapy Versus Investigator's Choice of Therapy in Patients With Relapsed or Refractory Non-GCB Diffuse Large B-Cell Lymphoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized controlled, multicenter Phase II clinical study primarily evaluating the efficacy and safety of Rocbrutinib monotherapy compared to the investigator's choice of BR/R2 regimen in patients with non-GCB DLBCL.

Conditions

• Diffuse Large B-Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	Rocbrutinib	200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc.
DRUG	Bendamustine	Participants will receive a total of 6 cycles (a cycle being 28 days) 90 mg/m2 Bendamustine (IV infusion) on Days 1 and 2 of Cycles 1-6.
DRUG	Rituximab	Participants will receive a total of 6 cycles (a cycle being 28 days) of 375 mg/m2 Rituximab (IV infusion) on Day 1 of each cycle.
DRUG	Lenalidomide	20mg qd PO day 1-21

Timeline

• Start date: 2025-11-27
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2025-09-23
• Last updated: 2025-12-16

Locations

41 sites across 1 country: China

Regulatory

• FDA-regulated drug study