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

Official title

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

Overview

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.

Interventions

• 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

Primary outcome measures

• Overall Response Rate [Time frame: Up to 24 Months]

Secondary outcome measures (7)

• Overall Response Rate [Time frame: Up to 24 Months]
• Complete remission rate [Time frame: Up to 24 Months]
• Progression Free Survival [Time frame: Up to 24 months]
• Overall survival [Time frame: 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.]
• Duration of Response (DOR) [Time frame: Up to 24 months]
• Time to Response (TTR) [Time frame: Measured from the date of the first dose of study drug to the date of earliest response, and assessed up to 6 months.]
• Safety Assessment [Time frame: From first dose of study drug to 28 days after last dose of study drug]

Eligibility criteria

Inclusion criteria

• Age ≥18 years, any gender.
• 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).
• 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).
• At least one measurable lesion (nodal lesion with longest diameter >1.5 cm, extranodal lesion with longest diameter >1.0 cm).
• Not planned for autologous stem cell transplantation (ASCT).
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2.

Exclusion criteria

• Primary central nervous system (CNS) lymphoma or known involvement of lymphoma in the CNS (including patients whose CNS lymphoma is currently in complete remission).
• 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).
• 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.
• 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.
• Previous refractoriness to BTK-targeting drugs.
• Patients who have received autologous stem cell transplantation within 90 days prior to randomization; patients who have received allogeneic stem cell transplantation.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 41 centers

• Anhui Cancer Hospital (West Branch of Anhui Provincial Hospital) — Hefei
• Beijing Shijitan Hospital — Beijing
• Beijing Tongren Hospital — Beijing
• National Cancer Center/Chinese Academy of Medical Sciences — Beijing
• Peking University Third Hospital — Beijing
• The First Affiliated Hospital of Chongqing Medical University — Chongqing
• Fujian Cancer Hospital — Fuzhou
• Affiliated Cancer Hospital of Guangzhou Medical University — Guangzhou
• … and 33 more centers

Identifiers

NCT: NCT07189065 · LP-168-CN203

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗