A Study of Rocbrutinib in Participants With Relapse or Refractory Non-GCB Diffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Lupeng Pharmaceutical Company LTD.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Rocbrutinib
Drug200mg qd PO. The treatment will continue until progressive disease, unacceptable toxicity, etc.
Bendamustine
DrugParticipants 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
DrugParticipants 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
Drug20mg qd PO day 1-21
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: RocbrutinibExperimental treatment 1 intervention
Group B: BR/R2Active comparator 3 interventions
Trial outcomes
Primary outcomes
1
Overall Response Rate
To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by Independent Reading Committee (IRC).
Time frame
Up to 24 MonthsSecondary outcomes
1
Overall Response Rate
To assess the anti-tumor activity of Rocbrutinib and BR/R2 based on overall response rate (ORR) as assessed by investigator.
Time frame
Up to 24 Months2
Complete remission rate
To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on complete remission rate (CR) as assessed by investigator and IRC.
Time frame
Up to 24 Months3
Progression Free Survival
To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Progression Free Survival (PFS) as assessed by investigator and IRC.
Time frame
Up to 24 months4
Overall survival
To assess the preliminary anti-tumor activity of Rocbrutinib and BR/R2 based on Overall survival (OS) as assessed by investigator and IRC.
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.Sponsors and contacts
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Source ClinicalTrials.gov