Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment
NCT04116437 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96
Last updated 2026-01-28
Summary
The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma patients who have become intolerant of prior ibrutinib and/or acalabrutinib treatment, by comparing intolerance to adverse event profile as assessed by the recurrence and the change in severity of adverse events.
Conditions
- Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
- Waldenstrom Macroglobulinemia
Interventions
- DRUG
-
Zanubrutinib (BGB-3111) will be orally administered at a dose of 160 mg twice daily or 320mg once daily until disease progression, unacceptable toxicity, treatment consent withdrawal, or study termination.
Sponsors & Collaborators
-
BeiGene
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-15
- Primary Completion
- 2026-01-09
- Completion
- 2026-01-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
BGB 3111 in Combination With Obinutuzumab in Participants With B-Cell Lymphoid Malignancies
NCT02569476 ·Status: COMPLETED ·Phase: PHASE1
-
Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies
NCT04170283 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
NCT03206970 ·Status: COMPLETED ·Phase: PHASE2
-
Zanubrutinib (BGB-3111) in Combination With Tislelizumab (BGB-A317) in Participants With B-cell Malignancies
NCT02795182 ·Status: COMPLETED ·Phase: PHASE1
-
Study of BGB-10188 as Monotherapy, and in Combination With Zanubrutinib, and Tislelizumab
NCT04282018 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study of Zanubrutinib (BGB-3111) in Participants With Marginal Zone Lymphoma
NCT03846427 ·Status: COMPLETED ·Phase: PHASE2
-
BTK Inhibitor BGB-3111 in Chinese Participants With Diffuse Large B-Cell Lymphoma (Non-GCB) and Indolent Lymphoma (FL and MZL)
NCT03520920 ·Status: COMPLETED ·Phase: PHASE2
-
Zanubrutinib, in Combination With Lenalidomide, With or Without Rituximab in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT04436107 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Investigate the Efficacy of Zanubrutinib Plus Rituximab Compared With Bendamustine Plus Rituximab in Adults With Previously Untreated Mantle Cell Lymphoma Who Are Ineligible for Stem Cell Transplantation
NCT04002297 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Zanubrutinib, Chidamide, and Rituximab Induction With or Without CHOP Versus R-CHOP in Newly Diagnosed Double-Expressor DLBCL
NCT06890585 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
A Study Comparing Obinutuzumab and BGB-3111 Versus Obinutuzumab Alone in Treating R/R Follicular Lymphoma
NCT03332017 ·Status: COMPLETED ·Phase: PHASE2
-
Ibrutinib in Combination With Lenalidomide and Rituximab in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma
NCT02077166 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Zanubrutinib in the Treatment of Recurrent Refractory Mantle Cell Lymphoma
NCT05486013 ·Status: RECRUITING
-
A Phase II Study of Zanubrutinib, Lenalidomide Plus R-CHOP as the First-line Treatment for Diffused Large B-cell Lymphoma
NCT05200312 ·Status: UNKNOWN ·Phase: PHASE2
-
Exploratory Study on the Efficacy of Zebutinib as Maintenance Therapy Following CAR-T Cell Therapy in Patients With Non-Hodgkin B-Cell Lymphoma
NCT07198373 ·Status: NOT_YET_RECRUITING
-
A Study of Cirmtuzumab and Ibrutinib in Patients With B-Cell Lymphoid Malignancies
NCT03088878 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Lymphomas
NCT02401048 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Zanubrutinib in Combination With Odronextamab for the Treatment of Patients With Richter's Transformation
NCT06735664 ·Status: RECRUITING ·Phase: PHASE1
-
Cardiovascular Complications of Ibrutinib Therapy
NCT05939752 ·Status: TERMINATED
-
A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies
NCT06634589 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Zanubrutinib Monotherapy in Relapsed/Refractory Central Nervous System Lymphoma
NCT05117814 ·Status: UNKNOWN ·Phase: NA
-
Orelabrutinib Therapy in Patients With r/r B-cell Lymphoma Intolerant to Other Bruton Tyrosine Kinase Inhibitors
NCT05495828 ·Status: RECRUITING
-
Zanubrutinib and Lenalidomide as Maintenance Therapy in DLBCL
NCT06503263 ·Status: RECRUITING ·Phase: PHASE2
-
Treatment of CD79B Mutant Relapsed/Refractory Diffuse Large B-Cell Lymphoma With Bruton Tyrosine Kinase Inhibitor Zanubrutinib
NCT05068440 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors
NCT06846671 ·Status: RECRUITING ·Phase: PHASE3