A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström’s Macroglobulinemia (WM)

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Macroglobulinemia and in IgM-MGUS Vaccine Therapy in Treating Patients With Lymphoplasmacytic Lymphoma Ofatumumab and Bortezomib in Treating Patients With Previously Untreated Waldenstrom Macroglobulinemia Perifosine in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia Randomised Trial in Waldenstrom’s Macroglobulinaemia A Study of Ibrutinib (PCI-32765) in Chinese Participants With Relapse or Refractory Waldenstrom’s Macroglobulinemia (WM) Pomalidomide, Dexamethasone and Rituximab in Waldenstrom’s Macroglobulinemia Study of the Combination of Bortezomib, Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia Study of Epratuzumab (hLL2) in Patients With Waldenstrom’s Macroglobulinemia A Study for Patients That Have Been Previously Been Treated in Waldenstrom’s Macroglobulinemia or Multiple Myeloma Ibrutinib With Rituximab in Adults With Waldenström’s Macroglobulinemia Oblimersen in Treating Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström’s Macroglobulinaemia An Open-label, Phase 2 Study of Acalabrutinib in Subjects With Waldenström Macroglobulinemia Simvastatin in Waldenstrom’s Macroglobulinemia Ibrutinib (PCI-32765) in Waldenstrom’s Macroglobulinemia Carfilzomib, Rituximab and Dexamethasone in Waldenstrom’s Macroglobulinemia Thalidomide and Rituximab in Waldenstrom’s Macroglobulinemia Comparison of ASCT and Conventional Chemotherapy in High Risk Waldenström Macroglobulinemia Fase II Study With BRB for Non-Hodgkin Lymphoplasmacytic Lymphoma/Waldenstrom Macroglobulinemia’s Study of Lenalidomide in Relapse/Refractory Waldenstrom Macroglobulinemia Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia A Study of Daratumumab in Patients With Relapsed or Refractory Waldenström Macroglobulinemia A Study of Ulocuplumab And Ibrutinib in Symptomatic Patients With Mutated CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief Title

A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)

Official Title

A Phase 3, Randomized, Open-Label, Multicenter Study Comparing the Efficacy and Safety of the Bruton's Tyrosine Kinase (BTK) Inhibitors BGB-3111 and Ibrutinib in Subjects With Waldenström's Macroglobulinemia (WM)

Brief Summary

      This study is to evaluate the safety, efficacy and clinical benefit of BGB-3111
      (Zanubrutinib) vs ibrutinib in participants with MYD88 Mutation Waldenström's
      Macroglobulinemia.
    

Detailed Description

      This open-label, randomized study will compare the efficacy and safety of the Bruton's
      Tyrosine Kinase (BTK) inhibitors BGB-3111 and ibrutinib in participants with Waldenström's
      Macroglobulinemia who require therapy. Participants will have baseline bone marrow samples
      assayed for sequencing of the MYD88 gene. Approximately 188 participants with the MYD88
      mutation will be enrolled onto Cohort 1 and randomized to receive 160 mg BGB-3111 PO BID
      (treatment Arm A) or to receive 420mg ibrutinib QD (treatment Arm B) until disease
      progression or unacceptable toxicity. Participants with MYD88 wild type will be enrolled to
      Cohort 2 and will receive 160 mg BGB-3111 PO BID (treatment Arm C) until disease progressive
      disease (PD) or unacceptable toxicity, withdrawal of consent, loss to follow-up, or study
      termination by Sponsor.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Proportion of participants achieving either a complete response (CR) or very good partial response (VGPR) in Cohort 1 using an adaptation of the response criteria updated at the Sixth IWWM as assessed by an independent review committee.

Secondary Outcome

 Efficacy measured by major response rate (MRR) in Cohort 1

Condition

Waldenström's Macroglobulinemia

Intervention

BGB-3111

Study Arms / Comparison Groups

 Arm A (Experimental Arm-BGB-3111)
Description:  Approximately 94 participants with the MYD88 mutation will be enrolled in Cohort 1 and receive BGB-3111 in treatment [Arm A]

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

229

Start Date

January 25, 2017

Completion Date

June 2021

Primary Completion Date

June 2021

Eligibility Criteria

        Key Inclusion Criteria:

          -  Clinical and definitive histologic diagnosis of WM

          -  Measurable disease, requiring treatment

          -  Participants with no prior therapy for WM, must be considered inappropriate candidates
             for treatment with a standard chemoimmunotherapy regimen

          -  Age ≥ 18 years old

          -  (ECOG) performance status of 0-2

          -  Adequate bone marrow function

          -  Adequate renal and hepatic function

          -  ECHO/MUGA demonstrating left ventricular ejection fraction (LVEF)≥ the lower limit of
             institutional normal

          -  Subjects may be enrolled who relapse after autologous stem cell transplant if they are
             at least 3 months after transplant, and after allogeneic transplant if they are at
             least 6 months post transplant.

          -  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. Males must have undergone sterilization- vasectomy, or utilize a
             barrier method

          -  Life expectancy of > 4 months

        Key Exclusion Criteria:

          -  Prior exposure to a BTK inhibitor

          -  Evidence of disease transformation at the time of study entry

          -  Corticosteroids given with antineoplastic intent within 7 days, or chemotherapy given
             with antineoplastic intent, targeted therapy, or radiation therapy within 3 weeks, or
             antibody-based therapy within 4 weeks of the start of study drug

          -  Major surgery within 4 weeks of study treatment

          -  Toxicity of ≥ Grade 2 from prior anticancer therapy

          -  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
             with curative intent

          -  Currently active, clinically significant cardiovascular disease such as uncontrolled
             arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease within 6 months
             of screening

          -  QTcF prolongation (defined as a QTcF > 450 msec)

          -  Active, clinically significant Electrocardiogram (ECG) abnormalities

          -  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

          -  Uncontrolled active systemic infection or recent infection requiring parenteral
             anti-microbial therapy

          -  Known human immunodeficiency virus (HIV), or active hepatitis B or hepatitis C

          -  Pregnant or lactating women

          -  Any life-threatening illness, medical condition, organ system dysfunction, need for
             profound anticoagulation, or bleeding disorder, which, in the investigator's opinion,
             could compromise the subject's safety

          -  Any medications which are strong or moderate cytochrome P450, family 3, subfamily A
             (CYP3A) inhibitors or strong CYP3A inducers

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Aileen Cohen, MD, , 

Location Countries

Australia

Location Countries

Australia

Administrative Informations


NCT ID

NCT03053440

Organization ID

BGB-3111-302

Secondary IDs

2016-002980-33

Responsible Party

Sponsor

Study Sponsor

BeiGene


Study Sponsor

Aileen Cohen, MD, Study Director, BeiGene


Verification Date

April 2021