Zanubrutinib in Maintenance Therapy of DLBCL Patients With Initial Remission
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLanZhou University
About this trial
This trial is a single-center, single-arm, prospective clinical study to investigate the efficacy and safety of zanubrutinib maintenance therapy in patients with diffuse large B-cell lymphoma (DLBCL) in Initial remission. The patients were divided into two categories: 1) Zanubrutinib maintenance therapy was started after R-CHOP induction and consolidation therapy reached maximum efficacy; 2) Initiate zanubrutinib maintenance therapy after maximal response to induction and consolidation therapy with or without rituximab (R-chemo). Therefore, the data in this study will reflect the efficacy and safety of zanubrutinib in the maintenance treatment of DLBCL patients with initial remission, and will provide new insights into the clinical application of zanubrutinib.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with DLBCL who are diagnosed according to the 2021 NCCN Guidelines for B-cell Lymphoma, aged ≥18 years;
Don't received treatment;
Measurable lesions: at least 1 lymph node lesion > 1.5 cm in longest dimension, or at least 1 extranodal lesion > 1.0 cm in longest dimension, and at least 2 measurable lesions accurately measured vertical diameter;
Clinical stage II (not suitable for local radiotherapy), III, IV (Ann Arbor stage); Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
Disqualifiers
Lymphoma with central nervous system invasion or mediastinal large B-cell lymphoma, diagnosis or treatment of malignant tumors other than DLBCL;
Cannot tolerate zanubrutinib treatment, or have hypersensitivity reactions to any components of the study drug;
Myocardial infarction within 6 months prior to screening;
Unstable angina pectoris occurring within 3 months prior to screening;
Trial design
Design model
Single group
Treatments tested in this trial
Zanubrutinib
DrugZanubrutinib, 180mg, bid, p.o., d1-28; Treatment cycles every 28 days
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Event-free survival (EFS)
EFS was defined as the time from initiation of zanubrutinib maintenance therapy to the occurrence of any event, including death, disease progression, change in chemotherapy regimen, change to chemotherapy, addition of other treatments, occurrence of fatal or intolerable side effects, etc. Whichever occurs first.
Time frame
up to 36 monthsSecondary outcomes
1
Conversion rate of partial response (PR) to CR
the total proportion of patients who had a partial response to initial therapy converted to CR at any time point after starting zanubrutinib maintenance therapy and will be reported as converted to CR at 3, 6, 12 months, and any other time point.
Time frame
up to 36 months2
Progression-free survival (PFS)
PFS was defined as the duration from initiation of zanubrutinib maintenance therapy to disease progression, CR recurrence, or death, whichever occurred first.
Time frame
up to 36 months3
Overall survival (OS)
OS was defined as the duration from the date of initiation of zanubrutinib maintenance therapy to the date of death.
Time frame
up to 36 months4
adverse event
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame
Adverse events were assessed during 3, 6, and 12 months after the start of zanubrutinib maintenance therapy and 6, 12, and 24 months after the end of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
LanZhou University
Lead sponsor
BeOne Medicines
Collaborator
Source ClinicalTrials.gov
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