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

Sponsor
Guangzhou Lupeng Pharmaceutical Company LTD.
Study ID
NCT07189065
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B-Cell Lymphoma (DLBCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rocbrutinib — DRUG
    200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc.
  • Bendamustine — DRUG
    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.
  • Rituximab — DRUG
    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.
  • Lenalidomide — DRUG
    20mg qd PO day 1-21

Study Details

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.

Key Dates

Start date
Nov 27, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rocbrutinib
  • Active Comparator: BR/R2

Primary Outcome Measure

Overall Response Rate [ Time Frame: Up to 24 Months ]

Central Contacts

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