TriangleNCT03206970 · CITED IN SOURCE DOCUMENTS
Study to Evaluate Efficacy and Safety of BGB-3111 in Participants With Relapsed or Refractory Mantle Cell Lymphoma (MCL)
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2024-10-26
The primary objective of this study was to evaluate the efficacy of zanubrutinib in participants with centrally confirmed relapsed or refractory MCL.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Overall Response Rate (ORR) As Assessed By Independent Review Committee
Progression-free Survival
Time To Response
Duration Of Response
ORR As Assessed By The Investigator
Number Of Participants Experiencing Treatment -Emergent Adverse Events (AEs)
Number Of Participants Experiencing AEs Leading To Treatment Discontinuation
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Key Inclusion Criteria: 1. Diagnostic report had to include evidence for morphological and cyclin D1 or t (11; 14). 2. Eastern Cooperative Oncology Group performance status of 0-2. 3. Measurable disease by computed tomography/magnetic resonance imaging. 4. Received prior regimens for MCL. 5. Documented failure to achieve any response, (stable disease or progressive disease during treatment) or documented progressive disease after response to the most recent treatment regimen. 6. Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN). 7. Total bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome). 8. Life expectancy of \> 4 months. Key Exclusion Criteria: 1. Current or history of central nervous system lymphoma. 2. Prior exposure to a BTK inhibitor before enrollment. 3. Prior corticosteroids with anti-neoplastic intent within 7 days. 4. Major surgery within 4 weeks of screening. 5. Toxicity must have recovered from prior chemotherapy. 6. History of other active malignancies within 2 years of study entry. 7. Currently clinically significant active cardiovascular disease. 8. QT interval corrected with Fridericia's formula \> 450 microseconds or other significant electrocardiogram abnormalities. 9. Uncontrolled systemic infection or infection requiring parenteral anti-microbial therapy. 10. Known human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction). Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
- healthy Volunteers
- false
- maximum Age
- 75 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Zanubrutinib (160 milligrams) administered orally twice daily
- intervention Names
- Drug: Zanubrutinib
- label
- Zanubrutinib
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Zanubrutinib
- description
- Administered as specified in the treatment arm.
- name
- Zanubrutinib
- other Names
- BGB-3111
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 86
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The ORR was assessed in accordance with the 2014 modification of the International Working Group on non-Hodgkin Lymphoma Criteria. The ORR was defined as the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR). The BOR was defined as the best response recorded from the start of zanubrutinib until data cut or start of new antineoplastic treatment. Participants with no post-baseline response assessment (due to any reason) were considered non-responders for BOR.
- measure
- Overall Response Rate (ORR) As Assessed By Independent Review Committee
- time Frame
- Up to 1 year and 11 months
- secondary Outcomes
- description
- Progression-free survival was defined as the time from the starting date of zanubrutinib to the date of first documentation of disease progression or death, whichever occurred first. Participants who did not have disease progression were censored at their last valid tumor assessment. A six-month progression-free survival rate was defined as no disease progression after treated with zanubrutinib for over six months (under control). The 95% confidence interval (CI) lower bound was 33.1 months while the upper bound could not be estimated.
- measure
- Progression-free Survival
- time Frame
- Up to 3 years and 6 months
- description
- Time to response was defined as the time from treatment initiation to the first documentation of response.
- measure
- Time To Response
- time Frame
- Up to 3 years and 6 months
- description
- The duration of response was defined as the time from the date that the response criteria are first met to the date that Progressive Disease was objectively documented or death (whichever occurs first). Participants who did not have disease progression were censored at their last valid assessment.
- measure
- Duration Of Response
- time Frame
- Up to 3 years and 6 months
- description
- The ORR was assessed in accordance with the 2014 modification of the International Working Group on non-Hodgkin Lymphoma Criteria. The ORR was defined as the percentage of participants achieving a BOR of CR or PR. The BOR was defined as the best response recorded from the start of zanubrutinib until data cut or start of new antineoplastic treatment. Participants with no post-baseline response assessment (due to any reason) were considered non-responders for BOR. For this outcome measure, only investigator-assessed data are analyzed and reported because of the high rate of concordance between the Independent Review Committee and investigator assessments for the primary outcome measure of ORR.
- measure
- ORR As Assessed By The Investigator
- time Frame
- Up to 3 years and 6 months
- description
- An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. A treatment-emergent adverse event (TEAE) is defined as an AE that had an onset date or a worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days following study drug discontinuation (Safety Follow-up visit) or initiation of new anticancer therapy, whichever comes first.
- measure
- Number Of Participants Experiencing Treatment -Emergent Adverse Events (AEs)
- time Frame
- From the initiation of study drug until 30 days after the last dose (Up to 3 years and 6 months)
- description
- An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to the study drug or not. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
- measure
- Number Of Participants Experiencing AEs Leading To Treatment Discontinuation
- time Frame
- From the initiation of study drug until 30 days after the last dose (Up to 3 years and 6 months)
Full study description
- brief Summary
- The primary objective of this study was to evaluate the efficacy of zanubrutinib in participants with centrally confirmed relapsed or refractory MCL.
Source references
- references
- citation
- Yuqin Song, Keshu Zhou, Dehui Zou, Jianfeng Zhou, Jianda Hu, Haiyan Yang, Huilai Zhang, Jie Ji, Wei Xu, Jie Jin, Fangfang Lv, Ru Feng, Sujun Gao, Daobin Zhou, Haiyi Guo, Aihua Wang, James Hilger, Jane Huang, William Novotny, Muhtar Osman, Jun Zhu; Safety and Activity of the Investigational Bruton Tyrosine Kinase Inhibitor Zanubrutinib (BGB-3111) in Patients with Mantle Cell Lymphoma from a Phase 2 Trial. Blood 2018; 132 (Supplement 1): 148. doi: https://doi.org/10.1182/blood-2018-99-117956
- type
- RESULT
- citation
- Song Y, Zhou K, Zou D, Zhou J, Hu J, Yang H, Zhang H, Ji J, Xu W, Jin J, Lv F, Feng R, Gao S, Guo H, Zhou L, Elstrom R, Huang J, Novotny W, Wei R, Zhu J. Treatment of Patients with Relapsed or Refractory Mantle-Cell Lymphoma with Zanubrutinib, a Selective Inhibitor of Bruton's Tyrosine Kinase. Clin Cancer Res. 2020 Aug 15;26(16):4216-4224. doi: 10.1158/1078-0432.CCR-19-3703. Epub 2020 May 27.
- pmid
- 32461234
- type
- RESULT
- citation
- Tam CS, Opat S, Simpson D, Cull G, Munoz J, Phillips TJ, Kim WS, Rule S, Atwal SK, Wei R, Novotny W, Huang J, Wang M, Trotman J. Zanubrutinib for the treatment of relapsed or refractory mantle cell lymphoma. Blood Adv. 2021 Jun 22;5(12):2577-2585. doi: 10.1182/bloodadvances.2020004074.
- pmid
- 34152395
- type
- RESULT
- citation
- Moslehi JJ, Furman RR, Tam CS, Salem JE, Flowers CR, Cohen A, Zhang M, Zhang J, Chen L, Ma H, Brown JR. Cardiovascular events reported in patients with B-cell malignancies treated with zanubrutinib. Blood Adv. 2024 May 28;8(10):2478-2490. doi: 10.1182/bloodadvances.2023011641.
- pmid
- 38502198
- type
- DERIVED
- citation
- Song Y, Zhou K, Zou D, Zhou J, Hu J, Yang H, Zhang H, Ji J, Xu W, Jin J, Lv F, Feng R, Gao S, Guo H, Zhou L, Huang J, Novotny W, Kim P, Yu Y, Wu B, Zhu J. Zanubrutinib in relapsed/refractory mantle cell lymphoma: long-term efficacy and safety results from a phase 2 study. Blood. 2022 May 26;139(21):3148-3158. doi: 10.1182/blood.2021014162.
- pmid
- 35303070
- type
- DERIVED
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-b173bc9ad653e0f5e7c6
- requested nct id
- NCT03206970
- primary nct id
- NCT03206970
- source kind
- fda_spl_label
- source record id
- 29341b77-7deb-445a-ae2c-a8e01c932daf
- source file sha256
- fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
- payload sha256
- 059f3e2feff1f35bdb37b361cb9031d33b676e7cfb9df393446fd63b0e1d5beb
- payload
- application numbers
- NDA213217
- NDA218785
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-b173bc9ad653e0f5e7c6
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT03206970
- occurrences
- context exact
- 14 CLINICAL STUDIES 14.1 Mantle Cell Lymphoma The efficacy of BRUKINSA was assessed in BGB-3111-206 [NCT03206970], a Phase 2, open-label, multicenter, single-arm trial of 86 previously treated patients with MCL who had received at least one prior therapy. BRUKINSA was giv
- end
- 112
- exact text
- NCT03206970
- start
- 101
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00100.json
- source file sha256
- fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
- source json pointer
- /results/49/clinical_studies/0
- source kind
- fda_spl_label
- source record id
- 29341b77-7deb-445a-ae2c-a8e01c932daf
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 568216a9881d887242989d7a2614d2fe2f7e4dd08e6f60e050342cb67cd8e676
- spl effective time
- 20260721
- spl set id
- 3e08fe23-d70e-424c-bc51-1222e320f902
- release id
- ctgov-registry-7ad944f6deaf1f5cd6122126
- edge id
- nct-edge-b9d4068ec302ce442040
- requested nct id
- NCT03206970
- primary nct id
- NCT03206970
- source kind
- fda_spl_label
- source record id
- 29341b77-7deb-445a-ae2c-a8e01c932daf
- source file sha256
- fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
- payload sha256
- 95e38790b878f8b084010947f4b35f3783aaa39e4b4325d6db857d46c524fc88
- payload
- application numbers
- NDA213217
- NDA218785
- clinical indication matching status
- not_inferred
- end exclusive
- true
- id
- nct-edge-b9d4068ec302ce442040
- link basis
- explicit_NCT_identifier_in_acquired_source
- nct id
- NCT03206970
- occurrences
- context exact
- ma (MCL) The safety of BRUKINSA was evaluated in 118 patients with MCL who received at least one prior therapy in two single-arm clinical trials, BGB-3111-206 [NCT03206970] and BGB-3111-AU-003 [NCT02343120] [see Clinical Studies (14.1) ] . The median age of patients who received BRUKINSA in studies BGB-3111-206 and BGB-3111-AU-00
- end
- 1991
- exact text
- NCT03206970
- start
- 1980
- offset unit
- unicode_code_points
- source file
- /tmp/cancer-full-research/indications/raw/labels-00100.json
- source file sha256
- fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058
- source json pointer
- /results/49/adverse_reactions/0
- source kind
- fda_spl_label
- source record id
- 29341b77-7deb-445a-ae2c-a8e01c932daf
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- 7e2eef1b446f347922ed45c1617a07a6877a3784ed67312bb32e16c79fd44b0d
- spl effective time
- 20260721
- spl set id
- 3e08fe23-d70e-424c-bc51-1222e320f902
Preserved source evidence · Not medical advice