Clinical trial · Interventional
BGB 3111 in Combination With Obinutuzumab in Participants With B-Cell Lymphoid Malignancies
A Phase 1b Study to Assess Safety, Tolerability and Antitumor Activity of the Combination of BGB 3111 With Obinutuzumab in Subjects With B-Cell Lymphoid Malignancies
NCT02569476CI-TRIAL-00081968completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluated the safety and preliminary efficacy of BGB-3111 (zanubrutinib) in combination with obinutuzumab in participants with B-cell lymphoid malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Lymphoid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Obinutuzumab | Drug | Obinutuzumab | ALIAS |
| Zanubrutinib | Drug | Zanubrutinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zanubrutinib and Obinutuzumab
- description
- In the dose-escalation part, dose levels and regimens were evaluated. In the indication-specific expansion cohorts, participants were assigned to different cohorts based on histology type.
- interventionNames
- Drug: Zanubrutinib
- Drug: Obinutuzumab
Primary outcomes (5)
- measure
- Part 1 : Number Of Participants Experiencing Adverse Events
- timeFrame
- Day 1 (first dose) through 4 years and 8 months
- description
- An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product (zanubrutinib in combination with obinutuzumab). An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study drug. A serious AE (SAE) was any untoward medical occurrence that, at any dose. * resulted in death, * was life threatening, * required hospitalization or prolongation of existing hospitalization, * resulted in disability/incapacity, * was a congenital anomaly/birth defect.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDLiu Y, Ma X, Wu X, Hou X, Jin W, Fu L, Xun X, Yu Y, Shen Z. Zanubrutinib is effective in non-germinal-center B-cell-like diffuse large B-cell lymphoma with mutated CD79B, high TCL1A expression, or over- expressed MYC/BCL-2. Leuk Lymphoma. 2024 Aug;65(8):1079-1089. doi: 10.1080/10428194.2024.2343779. Epub 2024 May 22. PMID 38775302
- DERIVEDTam CS, Quach H, Nicol A, Badoux X, Rose H, Prince HM, Leahy MF, Eek R, Wickham N, Patil SS, Huang J, Prathikanti R, Cohen A, Elstrom R, Reed W, Schneider J, Flinn IW. Zanubrutinib (BGB-3111) plus obinutuzumab in patients with chronic lymphocytic leukemia and follicular lymphoma. Blood Adv. 2020 Oct 13;4(19):4802-4811. doi: 10.1182/bloodadvances.2020002183. PMID 33022066