bgb 3111 in combination with obinutuzumab in participants with b-cell lymphoid malignancies

Conditions: B-cell Lymphoid Malignancies

Summary: this study evaluated the safety and preliminary efficacy of bgb-3111 (zanubrutinib) in combination with obinutuzumab in participants with b-cell lymphoid malignancies.


Eligibility criteria:
inclusion criteria: * aged ≥18 years, able and willing to provide written informed consent and to comply with the study protocol. * laboratory parameters as specified below: * hematologic: platelet count \>40x10\^9/liter (l) (may be post-transfusion); absolute neutrophil count \>1.0x10\^9/l (growth factor use is allowed to bring pre-treatment neutrophils to \>1.0x10\^9 cells/l if marrow infiltration is involved). * hepatic: total bilirubin \<3 x upper limit normal (uln); and aspartate aminotransferase and alanine transaminase ≤3 x uln. * renal: creatinine clearance ≥50 milliliters/minute (as estimated by the cockcroft gault equation or as measured by nuclear medicine scan or 24-hour urine collection); participants requiring hemodialysis will be excluded. * anticipated survival of at least 6 months. * eastern cooperative oncology group performance status of 0 to 2. * female participants of childbearing potential and non-sterile males must have agreed to practice at least one of the following methods of birth control with partner(s) throughout the study and for ≥3 months after discontinuing zanubrutinib or ≥18 months following obinutuzumab treatment, whichever was longer: total abstinence from sexual intercourse, double barrier contraception, intra uterine device or hormonal contraceptive initiated at least 3 months prior to first administration of study drug. * male participants must have not donated sperm from first study drug administration, until 3 months after zanubrutinib discontinuation or 18 months following obinutuzumab treatment, whichever is longer. exclusion criteria: * known central nervous system lymphoma or leukemia. * known prolymphocytic leukemia or history of, or currently suspected, richter's syndrome. * uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura. * history of significant cardiovascular disease. * severe or debilitating pulmonary disease. * history of severe allergic or anaphylactic reactions to monoclonal antibody therapy. * prior bruton tyrosine kinase inhibitor treatment. * used medications which were strong cytochrome p450 (cyp) 3a inhibitors and strong cyp3a inducers. * vaccination with a live vaccine within 28 days of the initiation of treatment. * allogeneic stem cell transplantation within 6 months, or had active graft versus host disease requiring ongoing immunosuppression. * receipt of the following treatment prior to first administration of zanubrutinib, corticosteroids given with anti-neoplastic intent within 7 days, chemotherapy or radiotherapy within 3 weeks, monoclonal antibody within 4 weeks. * participated in any investigational drug study within 28 days of study entry, or not recovered from non-hematologic toxicity of any prior chemotherapy up to ≤ grade 1 (except for alopecia). * history of other active malignancies within 2 years of study entry. * major surgery in the past 4 weeks. * active symptomatic fungal, bacterial and/or viral infection including evidence of infection with human immunodeficiency virus, human t cell lymphotropic virus seropositive status. * inability to comply with the study procedures. * pregnant or nursing women. * any illness or condition that in the opinion of the investigator may have affected the safety of treatment or evaluation of any study's endpoints.

Keywords: bgb-3111 zanubrutinib obinutuzumab lymphoma leukemia therapeutic uses b-cell