Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib
About the study
Who can take part
INCLUSION CRITERIA
Inclusion Criteria:
- Histologically confirmed DLBCL based on the World Health Organization (WHO) 2008 classification of tumors of hematopoietic and lymphoid tissue.
- Positive CD79B mutation confirmed by the central laboratory.
- Previously received at least 1 line of adequate systemic anti-DLBCL therapy, defined as an anti-CD20 antibody-based chemoimmunotherapy for at least 2 consecutive cycles, unless participants had disease progression before Cycle 2
Relapsed or refractory (R/R) disease before study entry, defined as either
- Recurrent disease after having achieved disease remission (CR or partial response [PR]) at the completion of the latest treatment regimen.
- Stable disease or PD at the completion of the latest treatment regimen
Ineligible for high dose therapy/stem cell transplantation, which is defined as meeting any of the following criteria:
- Significant organ dysfunction (eg, left ventricular ejection fraction < 50% by echocardiogram or multiple gated acquisition scan [MUGA], diffuse lung capacity for carbon monoxide < 60% predicted by pulmonary function test, creatinine clearance < 70 mL/min shown by nuclear medicine scan or 24-hour urine collection) or comorbidities precluding the use of high dose therapy/stem cell transplantation on the basis of unacceptable risk of treatment-related morbidity
- Failure to achieve CR or PR with salvage therapy.
- Failure to collect stem cells or unable to perform stem cell collection as assessed by the investigator.
EXCLUSION CRITERIA
Exclusion Criteria:
- Participants who have NHL other than classical histology DLBCL (DLBCL, not otherwise specified), eg, participants with DLBCL transformed from indolent lymphomas, primary mediastinal (thymic) large B-cell lymphoma, primary cutaneous DLBCL, primary effusion lymphoma, and central nervous system (CNS) lymphoma.
- History of allogeneic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy.
- Prior exposure to a Bruton's tyrosine kinase (BTK) inhibitor.
Receipt of the following treatment at the time indicated before the first dose of study drug:
- Corticosteroid given with antineoplastic intent within 2 weeks, but a short course (≤ 7 days) of systemic corticosteroid treatment at doses ≤ 20 mg/day prednisone equivalent for control of lymphoma-related symptoms is allowed prior to enrollment provided that it is tapered off within 5 days after initiation of study treatment.
- Chemotherapy or radiotherapy within 2 weeks.
- Monoclonal antibody within 2 weeks.
- Investigational therapy within 2 weeks.
- Chinese patent medicine with antineoplastic intent within 2 weeks.
- History of other active malignancies within 2 years before study entry, with the exception of (1) adequately treated in-situ carcinoma of the cervix; (2) localized basal cell or squamous cell carcinoma of the skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Locations
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How to Apply
Study’s details
Contition
Relapsed Diffuse Large B-cell Lymphoma,Refractory Diffuse Large B-cell Lymphoma
Age (in years)
18+
Phase
Phase 2
Participants needed
66
Est. Completion Date
Dec 30, 2024
Treatment type
Interventional
Sponsor
BeiGene
ClinicalTrials.gov identifier
NCT05068440
Study number
BGB-3111-218
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