Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04116437
Collaborator
(none)
90
31
1
68.5
2.9
0

Study Details

Study Description

Brief 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Multicenter, Single-arm Study of Zanubrutinib (BGB-3111) in Patients With Previously Treated B-Cell Lymphoma Intolerant of Prior Treatment With Ibrutinib and/or Acalabrutinib
Actual Study Start Date :
Oct 15, 2019
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jul 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Zanubrutinib

Cohort 1: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with ibrutinib Cohort 2: Chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), or marginal zone lymphoma (MZL) previously treated with acalabrutinib alone/with ibrutinib

Drug: Zanubrutinib
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.
Other Names:
  • BGB-3111
  • BRUKINSA
  • Outcome Measures

    Primary Outcome Measures

    1. Recurrence and change in severity of treatment-emergent Adverse Events (AEs) of interest. [24 months]

    Secondary Outcome Measures

    1. Overall response as determined by investigator [24 months]

    2. Progression free survival (PFS) as determined by investigator [24 months]

    3. Patient reported outcomes as measured by EuroQol five dimension scale (EQ-5D) [24 months]

    4. Patient reported outcomes as measured by European Organisation for Research and Treatment of Cancer (EORTC) [24 months]

    5. Disease control rate as determined by investigator [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Key Inclusion Criteria:
    1. Participants must meet protocol defined disease criteria requiring treatment for their respective disease prior to initiation of ibrutinib or acalabrutinib

    2. Ibrutinib and acalabrutinib intolerance is defined as an unacceptable toxicity where, in the opinion of the investigator, treatment should be discontinued in spite of optimal supportive care as a result of one of the following:

    3. For ibrutinib and acalabrutinib intolerance events:

    • 1 or more ≥ Grade 2 nonhematologic toxicities for >7 days (with or without treatment)

    • 1 or more ≥ Grade 3 nonhematologic toxicity of any duration

    • 1 or more Grade 3 neutropenia with infection or fever of any duration; or

    • Grade 4 heme toxicity which persists to the point that the investigator chose to stop therapy due to toxicity NOT progression.

    1. For acalabrutinib intolerance events only;
    • 1 or more ≥ Grade 1 nonhematologic toxicities of any duration with > 3 recurrent episodes; or

    • 1 or more ≥ Grade 1 nonhematologic toxicities for > 7 days (with or without treatment); or

    • Inability to use acid-reducing agents or anticoagulants (eg, proton pump inhibitors, warfarin) due to concurrent acalabrutinib use

    1. Ibrutinib and/or acalabrutinib-related ≥ Grade 2 toxicities must have resolved to ≤ Grade 1 or baseline prior to initiating treatment with zanubrutinib. Grade 1 acalabrutinib-related toxicities must have resolved to Grade 0 or baseline prior to initiating treatment with zanubrutinib.

    2. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

    3. Absolute neutrophil count (ANC) ≥ 1000/mm3 with or without growth factor support and platelet count ≥ 50,000/mm3 (may be post-transfusion), on or prior to C1D1 of zanubrutinib

    Key Exclusion Criteria:
    1. Clinically significant cardiovascular disease including the following:

    2. Myocardial infarction within 6 months before the Screening

    3. Unstable angina within 3 months before the Screening

    4. New York Heart Association class III or IV congestive heart failure

    5. History of sustained ventricular tachycardia, ventricular fibrillation, and/or Torsades de Pointes

    6. QT interval corrected by Fridericia's formula > 480 milliseconds

    7. History of Mobitz II second-degree or third-degree heart block without a permanent pacemaker in place

    8. History of central nervous system (CNS) hemorrhage

    9. Documented progressive disease (PD) during ibrutinib and/or acalabrutinib treatment.

    10. Have received any anticancer therapy (other than immunotherapy) for CLL/SLL, WM, MCL, and MZL < 7 days before any Screening assessments are performed or any immunotherapy treatment, taken alone or as part of a chemoimmunotherapy regimen, < 4 weeks before any Screening assessments are performed

    11. Requires ongoing need for corticosteroid treatment > 10 mg daily of prednisone or equivalent corticosteroid. Note: Systemic corticosteroids must be fully tapered off/discontinued ≥ 5 days before the first dose of study drug is administered.

    NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Oncology Specialties, PC Huntsville Alabama United States 35805
    2 Arizona Oncology Associates - Tucson - Rudasill Road Tucson Arizona United States 85704
    3 Innovative Clinical Research Institute Whittier California United States 90603
    4 Rocky Mountain Cancer Centers Lone Tree Colorado United States 80124
    5 Medical Oncology Hematology Consultants, PA Newark Delaware United States 19713
    6 SCRI Florida Cancer Specialists South Fort Myers Florida United States 33901
    7 21st Century Oncology of Jacksonville - Medical Oncology Division Jacksonville Florida United States 32256
    8 Florida Cancer Specialists Saint Petersburg Florida United States 33770
    9 Healthcare Research Network Flossmoor Illinois United States 60472
    10 Comprehensive Cancer Centers of Nevada(CCCN) Las Vegas Nevada United States 89169
    11 Summit Medical Group (SMG) - Florham Park Campus Florham Park New Jersey United States 07932
    12 Hackensack University Medical Center Hackensack New Jersey United States 07601
    13 Atlantic Health System/Morristown Medical Center Morristown New Jersey United States 07960
    14 Manhattan Hematology Oncology Associates, P.C. New York New York United States 10016
    15 Clinical Research Alliance New York New York United States 10021
    16 Oncology Associates of Oregon - Willamette Valley Cancer Eugene Oregon United States 97401
    17 St. Luke's University Health Network Bethlehem Pennsylvania United States 18015
    18 Alliance Cancer Specialist Horsham Pennsylvania United States 19044
    19 Tennessee Oncology Nashville Tennessee United States 37203
    20 Texas Oncology-Amarillo Amarillo Texas United States 79106
    21 Texas Oncology-Arlington South Arlington Texas United States 76012
    22 Texas Oncology Austin Texas United States 78705
    23 Texas Oncology, P.A. - Baylor Charles A. Sammons Cancer Center Dallas Texas United States 75246
    24 Texas Oncology - Fort Worth Cancer Center Fort Worth Texas United States 76104
    25 Texas Oncology-McAllen South Second Street McAllen Texas United States 78503
    26 Texas Oncology, P.A. - Tyler Tyler Texas United States 75702
    27 Virginia Cancer Specialists Gainesville Virginia United States 20155
    28 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    29 Medical Oncology Associates Spokane Washington United States 99208
    30 Green Bay Oncology Green Bay Wisconsin United States 54301
    31 SSM Health Cancer Care Madison Wisconsin United States 53715

    Sponsors and Collaborators

    • BeiGene

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT04116437
    Other Study ID Numbers:
    • BGB-3111-215
    First Posted:
    Oct 4, 2019
    Last Update Posted:
    Jun 16, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by BeiGene
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 16, 2022