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NCT03332173 · REGISTRY CONDITION SEARCH

Study of BTK Inhibitor BGB-3111 in Chinese Subjects With Relapsed/Refractory Waldenström's Macroglobulinemia (WM)

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2024-10-26

This was a single-arm, multicenter Phase 2 study in Chinese participants with relapsed or refractory Waldenström's macroglobulinemia who exhibited one or more of the criteria for requiring treatment based on consensus guidelines from the Seventh International Workshop on Waldenström's Macroglobulinemia (IWWM). The study comprised an initial screening phase (up to 28 days), a single-arm treatment phase, and a follow-up phase.

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.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Major Response Rate (MRR) as Assessed by the Independent Review Committee

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

PFS: Event-free Rate

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outcome · POSTED

Overall Response Rate (ORR)

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outcome · POSTED

Duration of Major Response (DOMR)

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outcome · POSTED

DOMR: Event-free Rate

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outcome · POSTED

Number of Participants With Resolution of Treatment-precipitating Symptoms

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outcome · POSTED

Number of Participants With an Anti-lymphoma Effect

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outcome · POSTED

Number of Participants With Adverse Events

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Key Inclusion Criteria: 1. Clinical and definitive histologic diagnosis of WM, meeting at least one criterion for treatment according to consensus panel criteria from the Seventh IWWM. 2. WM pathology confirmation by central lab prior to study enrollment. Previous pathology report, concurrently with newly generated central lab report to be reviewed to support WM diagnosis. 3. Men and women ≥ 18 years of age. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 5. Previously treated with a minimum of 1 prior line of standard chemotherapy-containing regimen (with completion of ≥ 2 continuous treatment cycles). 6. Documented failure to achieve at least minor response or documented disease progression after response to the most recent treatment regimen. 7. Neutrophils ≥ 0.75 x 10\^9/L independent of growth factor support within 7 days of first dose. 8. Platelets ≥ 50 x 10\^9/L, independent of growth factor support or transfusion within 7 days of first dose. 9. Hemoglobin ≥80 g/L, independent of erythropoietin (EPO) support or transfusion within 7 days of first dose of study drug. 10. Creatinine clearance of ≥ 30 mL/min (as estimated by the Cockcroft-Gault equation or estimated glomerular filtration rate \[eGFR\] from the Modification of Diet in Renal Disease \[MDRD\]). 11. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x upper limit of normal (ULN). 12. Bilirubin ≤ 2 x ULN (unless documented Gilbert's syndrome). 13. International normalized ratio ≤ 1.5 and activated partial thromboplastin time ≤ 1.5 x ULN. Participants with lupus anticoagulant or acquired von Willebrand disease due to WM may be enrolled after discussion with the medical monitor. 14. ECHO must demonstrate left ventricular ejection fraction (LVEF) ≥50%. 15. Participants who relapse after autologous stem cell transplant may be enrolled if they are at least 6 months after transplant at screening. To be eligible after transplant, participants should have no active related infections. 16. Females of childbearing potential must agree to use highly effective forms of birth control throughout the course of the study and at least up to 90 days after last dose of study drug. Highly effective forms of birth control can be defined as abstinence, hysterectomy, bilateral oophorectomy with no menstrual bleeding for up to 6 months, intrauterine contraception, hormonal methods such as contraceptive injection, oral contraceptive, etc. Males must have undergone sterilization-vasectomy, or use a barrier method where the female partner uses the effective forms of birth control noted above and must not donate sperm for at least 90 days after last dose of study drug. 17. Life expectancy of \> 4 months. 18. Able to provide written informed consent and can understand and comply with the requirements of the study. Key Exclusion Criteria: 1. Central nervous system (CNS) involvement by WM. 2. Prior exposure to a BTK inhibitor. 3. Evidence of disease transformation. 4. Prior corticosteroids given in excess of prednisone 10 mg/day or its equivalent with antineoplastic intent within 7 days, prior chemotherapy, targeted therapy, or radiation therapy within 3 weeks, antineoplastic therapy with Chinese herbal medicine or antibody based therapies within 4 weeks of the start of study drug. 5. Major surgery within 4 weeks of randomization. 6. Toxicity of ≥ Grade 1 from prior anti-cancer therapy (except for absolute neutrophil count \[ANC\], platelets, and hemoglobin. For ANC, platelets, and hemoglobin, please follow inclusion criteria #7 \[neutrophils\], #8 \[platelets\], and #9 \[hemoglobin\]). 7. History of other active malignancies within 2 years of study entry, with exception of (1) adequately treated in-situ carcinoma of cervix; (2) localized basal cell or squamous cell carcinoma of skin; (3) previous malignancy confined and treated locally (surgery or other modality) with curative intent. 8. Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, uncontrolled hypertension, congestive heart failure, any Class 3 or 4 cardiac disease as defined by the New York Heart Association (NYHA) Functional Classification, or history of myocardial infarction within 6 months of screening. 9. QTcF prolongation (defined as a QTc \>480 msecs based on Fridericia's formula) or other significant ECG abnormalities including second degree atrioventricular (AV) block Type II, or third degree AV block. 10. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction. 11. Active infection including infections requiring oral or intravenous anti-microbial therapy. 12. Known human immunodeficiency virus (HIV), or active hepatitis B or hepatitis C infection (detected positive by polymerase chain reaction \[PCR\]). 13. Pregnant or lactating women. 14. Any life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, or put the study at risk. 15. On medications which are strong CYP3A inhibitors or strong CYP3A inducers. 16. History of stroke or intracranial hemorrhage within 6 months prior to enrollment. 17. Has received allogenic hematopoietic stem cell transplantation prior to enrollment. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Zanubrutinib 160 mg orally twice daily with or without food until progressive disease or intolerable toxicity
    intervention Names
    1. Drug: Zanubrutinib
    label
    Zanubrutinib
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Zanubrutinib
    description
    Oral administration using 80 mg capsules
    name
    Zanubrutinib
    other Names
    1. BGB-3111
    2. Brukinsa
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
44
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    MRR is defined as the percentage of participants who achieved complete response (CR) + very good partial response (VGPR) + partial response (PR), as assessed by an independent review committee according to modified Owen's criteria
    measure
    Major Response Rate (MRR) as Assessed by the Independent Review Committee
    time Frame
    Up to approximately 1 year and 9 months
secondary Outcomes
  1. description
    PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by an independent review committee using modified Owen's criteria
    measure
    Progression Free Survival (PFS)
    time Frame
    Up to approximately 1 year and 9 months
  2. description
    Progression/death event-free rates were estimated by Kaplan-Meier method with 95% confidence intervals (CIs) estimated using Greenwood's formula
    measure
    PFS: Event-free Rate
    time Frame
    Up to approximately 1 year and 9 months
  3. description
    ORR is defined as the percentage of participants with a minor, partial, very good partial, and complete response, as assessed by an independent review committee using modified Owen's criteria
    measure
    Overall Response Rate (ORR)
    time Frame
    Up to approximately 1 year and 9 months
  4. description
    DOMR is defined as the time from the date that the major response criteria are first met to the date that progressive disease (PD) is objectively documented or death, whichever comes first, as assessed by an independent review committee using modified Owen's criteria
    measure
    Duration of Major Response (DOMR)
    time Frame
    Up to approximately 1 year and 9 months
  5. description
    DOMR event-free rates were estimated by Kaplan-Meier method with 95% CIs estimated using Greenwood's formula
    measure
    DOMR: Event-free Rate
    time Frame
    Up to approximately 1 year and 9 months
  6. description
    Number of participants with resolution of treatment-precipitating symptoms, defined as any resolution (from "Yes" at baseline to "No" at any postbaseline point onwards during study) of the indications for initiation of therapy in WM signs and symptoms evaluation.
    measure
    Number of Participants With Resolution of Treatment-precipitating Symptoms
    time Frame
    Up to approximately 1 year and 9 months
  7. description
    Number of participants with an anti-lymphoma effect, defined as any reduction during the course of study in bone marrow involvement by lymphoplasmacytoid lymphocytes and/or size of lymphadenopathy and/or splenomegaly by computed tomography scan as assessed by an independent review committee; lymphadenopathy is defined as any node with longest diameter (LDi) \> 1.5 cm and splenomegaly is defined as vertical spleen length \> 13 cm
    measure
    Number of Participants With an Anti-lymphoma Effect
    time Frame
    Up to approximately 1 year and 9 months
  8. description
    Number of participants with treatment-emergent adverse events (TEAEs), grade 3 or higher TEAEs, serious adverse events (SAEs), treatment-related adverse events (AEs), adverse events of special interest, and TEAEs leading to study drug discontinuation, dose reduction and treatment interruption
    measure
    Number of Participants With Adverse Events
    time Frame
    Up to approximately 3 years and 5 months
Full study description
brief Summary
This was a single-arm, multicenter Phase 2 study in Chinese participants with relapsed or refractory Waldenström's macroglobulinemia who exhibited one or more of the criteria for requiring treatment based on consensus guidelines from the Seventh International Workshop on Waldenström's Macroglobulinemia (IWWM). The study comprised an initial screening phase (up to 28 days), a single-arm treatment phase, and a follow-up phase.
Source references
references
  1. citation
    An G, Zhou D, Cheng S, Zhou K, Li J, Zhou J, Xie L, Jin J, Zhong L, Yan L, Guo H, Du C, Zhong J, Yu Y, Wu B, Qiu L. A Phase II Trial of the Bruton Tyrosine-Kinase Inhibitor Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Waldenstrom Macroglobulinemia. Clin Cancer Res. 2021 Oct 15;27(20):5492-5501. doi: 10.1158/1078-0432.CCR-21-0539. Epub 2021 Jul 12.
    pmid
    34253577
    type
    BACKGROUND
  2. 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
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice