NCT07189065 A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma
| NCT ID | NCT07189065 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Guangzhou Lupeng Pharmaceutical Company LTD. |
| Condition | Diffuse Large B-Cell Lymphoma (DLBCL) |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-11-27 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2025-11-27 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years, any gender. 2. Pathologically confirmed DLBCL (not otherwise specified) according to the revised 2017 WHO classification of lymphoid neoplasms, with non-germinal center B-cell-like (non-GCB) subtype confirmed by Han's algorithm (Appendix 1), based on previous pathological records or confirmed during screening. Must be able to provide sufficient tumor tissue or slides (from previous or screening biopsies) for central laboratory confirmation of pathological diagnosis (if the local pathology report is clear, patients may be enrolled and start treatment without waiting for the central pathology report). 3. Patients who are refractory or have relapsed after at least two prior lines of therapy (at least one line must include an anti-CD20 antibody-containing regimen) (see section 6.3 for definition of refractory or relapsed). 4. At least one measurable lesion (nodal lesion with longest diameter \>1.5 cm, extranodal lesion with longest diameter \>1.0 cm). 5. Not planned for autologous stem cell transplantation (ASCT). 6. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2. Exclusion Criteria: 1. Primary central nervous system (CNS) lymphoma or known involvement of lymphoma in the CNS (including patients whose CNS lymphoma is currently in complete remission). 2. DLBCL resulting from histological transformation of an previously diagnosed indolent lymphoma \[such as follicular lymphoma (FL), marginal zone lymphoma, chronic lymphocytic leukemia, etc.\] or pathological findings suggesting concomitant FL (any grade). 3. Diagnosis of other types of large B-cell lymphoma or special types of DLBCL, including but not limited to high-grade B-cell lymphoma, EBV-positive DLBCL, T-cell/histiocyte-rich large B-cell lymphoma, primary mediastinal large B-cell lymphoma, etc. 4. Previous exposure to Lobertinib or known allergy to any excipient of Lobertinib (including microcrystalline cellulose, croscarmellose sodium, magnesium stearate, fumaric acid, and gastric-soluble film coating premix); allergy or intolerance to Rituximab or any of its excipients; allergy or intolerance to both Bendamustine and Lenalidomide or any of their excipients. 5. Previous refractoriness to BTK-targeting drugs. 6. Patients who have received autologous stem cell transplantation within 90 days prior to randomization; patients who have received allogeneic stem cell transplantation.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07189065 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Diffuse Large B-Cell Lymphoma (DLBCL). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07189065 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07189065 currently recruiting?
Yes, NCT07189065 is actively recruiting participants. Contact the research team at syuankaipumc@126.com for enrollment information.
Where is the NCT07189065 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT07189065 clinical trial?
NCT07189065 is sponsored by Guangzhou Lupeng Pharmaceutical Company LTD.. The trial plans to enroll 150 participants.