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
Qualifiers
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
Treatments tested in this trial
- Zanubrutinib
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
LanZhou University
Lead sponsor
BeOne Medicines
Collaborator
Source ClinicalTrials.gov