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

Not Applicable

Not yet recruiting

• Conditions: Diffuse Large B-Cell Lymphoma (DLBCL)
• Interventions: Drug: Rocbrutinib; Drug: Bendamustine; Drug: Rituximab; Drug: Lenalidomide

• Registration Number: NCT07189065
• Lead Sponsor: Guangzhou Lupeng Pharmaceutical Company LTD.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-16
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-23
• Last Update Posted: 2025-09-23
• Study Start: 2025-09-30
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocbrutinib	Rocbrutinib	-
BR/R2	Bendamustine	-
BR/R2	Rituximab	-
BR/R2	Lenalidomide	-

Primary Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 24 Months	To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 24 Months	To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by investigator.
Complete remission rate	Up to 24 Months	To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on complete remission rate (CR) as assessed by investigator and IRC.
Progression Free Survival	Up to 24 months	To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Progression Free Survival (PFS) as assessed by investigator and IRC.
Overall survival	Measured from the date of date of first dose to the date of death or last visit, and for up to 5 years after the last subject is enrolled.	To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Overall survival (OS) as assessed by investigator and IRC.
Duration of Response (DOR)	Up to 24 months	To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Duration of response (DOR) as assessed by the Investigator and IRC.
Time to Response (TTR)	Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.	To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Time to response (TTR) as assessed by the Investigator and IRC.
Safety Assessment	From first dose of study drug to 28 days after last dose of study drug	To evaluate the safety of Rocbrutinib and BR/R2 by assessing incidence and severity of treatment-emergent adverse events as determined by CTCAE v5.0

Trial Locations

Locations (41)

Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital); 🇨🇳 Hefei, Anhui, China

Beijing Shijitan Hospital; 🇨🇳 Beijing, Beijing Municipality, China

Beijing Tongren Hospital; 🇨🇳 Beijing, Beijing Municipality, China

National Cancer Center/Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing Municipality, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

Affiliated Cancer Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

Scroll for more (31 remaining)