Zanubrutinib

Generic Name: Zanubrutinib

Brand Names: Brukinsa

Drug Type: Small Molecule

Chemical Formula: C_₂₇H_₂₉N_₅O_₃

CAS Number: 1691249-45-2

Unique Ingredient Identifier: AG9MHG098Z

Background: Zanubrutinib is a novel Bruton's tyrosine kinase (BTK) inhibitor used for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Mantle cell lymphoma is an aggressive mature B-cell non-Hodgkin lymphoma associated with early relapse, poor clinical outcomes, and long-term survival. BTK is an enzyme that pl...

Indication: Zanubrutinib is indicated for the treatment of:

Associated Conditions: Chronic Lymphocytic Leukemia, Mantle Cell Lymphoma (MCL), Refractory Marginal Zone Lymphoma, Relapsed Marginal Zone Lymphoma, Small Lymphocytic Lymphoma, Waldenström's Macroglobulinemia (WM)

Associated Therapies: -

Clinical Trials

Comparison Between Rituximab Plus Zanubrutinib Versus Rituximab Monotherapy in Untreated SMZL Patients

Phase 3

Recruiting

Conditions: Splenic Marginal Zone Lymphoma

Interventions: Drug: Rituximab
Drug: Zanubrutinib

First Posted Date: 2023-02-21

Last Posted Date: 2024-11-27

Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)

Target Recruit Count: 120

Registration Number: NCT05735834

Locations: 🇦🇹
Medical University of Vienna, Vienna, Austria
🇩🇰
Aarhus University Hospital, Aarhus, Denmark
🇫🇷
Institut Bergonié, Bordeaux, France

and more 51 locations

Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study

Phase 2

Recruiting

Conditions: Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Biological: Tafasitamab
Drug: Zanubrutinib

First Posted Date: 2023-02-08

Last Posted Date: 2024-08-15

Lead Sponsor: City of Hope Medical Center

Target Recruit Count: 25

Registration Number: NCT05718869

Locations: 🇺🇸
City of Hope Medical Center, Duarte, California, United States
🇺🇸
City of Hope at Irvine Lennar, Irvine, California, United States
🇺🇸
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida, United States

A Study to Evaluate the Safety and Efficacy of Zanubrutinib in Participants With Primary Membranous Nephropathy

Phase 2

Recruiting

Conditions: Primary Membranous Nephropathy

Interventions: Drug: Zanubrutinib
Drug: Tacrolimus

First Posted Date: 2023-01-31

Last Posted Date: 2024-12-06

Lead Sponsor: BeiGene

Target Recruit Count: 282

Registration Number: NCT05707377

Locations: 🇺🇸
Carolina Nephrology, Spartanburg, South Carolina, United States
🇺🇸
Prolato Clinical Research Center, Houston, Texas, United States
🇨🇳
Zhejiang Provincial Peoples Hospital, Hangzhou, Zhejiang, China

and more 67 locations

Zanubrutinib With Pemetrexed to Treat Relapsed/Refractory Primary and Secondary Central Nervous System (CNS) Lymphomas

Phase 2

Recruiting

Conditions: Primary Central Nervous System Lymphoma
Secondary Central Nervous System Lymphoma
Relapsed Cancer
Refractory Cancer

Interventions: Drug: Pemetrexed
Drug: Zanubrutinib
Procedure: Autologous Stem Cell Transplant (ASCT)
Radiation: Whole Brain Radiation Therapy (WBRT)

First Posted Date: 2023-01-12

Last Posted Date: 2024-05-06

Lead Sponsor: Baptist Health South Florida

Target Recruit Count: 15

Registration Number: NCT05681195

Locations: 🇺🇸
Miami Cancer Institute at Baptist Health, Inc., Miami, Florida, United States

A Study of PRT2527 as Monotherapy and in Combination With Zanubrutinib or Venetoclax in Participants With R/R Hematologic Malignancies

Phase 1

Recruiting

Conditions: Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Mantle Cell Lymphoma (MCL)
Diffuse Large B-cell Lymphoma (DLBCL)
Acute Myeloid Leukemia (AML)
Myelodysplastic Syndrome (MDS)
Aggressive B-Cell Non-Hodgkin's Lymphoma (NHL)
MDS/Myeloproliferative Neoplasm (MPN) Overlap Syndrome
Richter's Syndrome
T-cell Lymphoma
Chronic Myelomonocytic Leukemia (CMML)

Interventions: Drug: PRT2527
Drug: Zanubrutinib
Drug: Venetoclax

First Posted Date: 2022-12-27

Last Posted Date: 2024-08-22

Lead Sponsor: Prelude Therapeutics

Target Recruit Count: 274

Registration Number: NCT05665530

Locations: 🇺🇸
American Oncology Partners of Maryland, PA, Bethesda, Maryland, United States
🇦🇺
Austin Health, Heidelberg, Victoria, Australia
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 21 locations

Observational Study Evaluating the Efficacy and Safety of Zanubrutinib in Participants With Waldenström Macroglobulinemia

Recruiting

Conditions: Waldenstrom Macroglobulinemia

Interventions: Drug: Zanubrutinib

First Posted Date: 2022-12-07

Last Posted Date: 2024-11-28

Lead Sponsor: BeiGene

Target Recruit Count: 111

Registration Number: NCT05640102

Locations: 🇺🇸
Clearview Cancer Institute, Huntsville, Alabama, United States
🇺🇸
Mitchell Cancer Institute, Mobile, Alabama, United States
🇺🇸
Valkyrie Clinical Trials, Los Angeles, California, United States

and more 13 locations

Zanubrutinib Plus Rituximab for Patients with Indolent Mantle Cell Lymphoma

Phase 2

Recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Zanubrutinib
Drug: Rituximab

First Posted Date: 2022-12-02

Last Posted Date: 2024-12-06

Lead Sponsor: University College, London

Target Recruit Count: 50

Registration Number: NCT05635162

Locations: 🇬🇧
Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom
🇬🇧
Guy's Hospital, London, United Kingdom
🇬🇧
Derriford Hospital, Plymouth, United Kingdom

and more 5 locations

Zanubrutinib in Maintenance Therapy of DLBCL Patients With Initial Remission

Phase 2

Not yet recruiting

Conditions: Diffuse Large B-cell Lymphoma (DLBCL)

Interventions: Drug: Zanubrutinib

First Posted Date: 2022-10-27

Last Posted Date: 2022-10-27

Lead Sponsor: LanZhou University

Target Recruit Count: 15

Registration Number: NCT05596097

Locations: 🇨🇳
The First Hospital of Lanzhou University, Lanzhou, Gansu, China

Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults

Phase 1

Completed

Conditions: Healthy Volunteers

Interventions: Drug: Zanubrutinib

First Posted Date: 2022-09-21

Last Posted Date: 2024-10-26

Lead Sponsor: BeiGene

Target Recruit Count: 43

Registration Number: NCT05547399

Locations: 🇺🇸
Fortrea Clinical Research Unit, Dallas, Texas, United States

A Study of Mosunetuzumab in People With Follicular Lymphoma

Phase 2

Recruiting

Conditions: Follicular Lymphoma
Lymphoma

Interventions: Drug: Mosunetuzumab
Drug: Zanubrutinib

First Posted Date: 2022-05-25

Last Posted Date: 2024-06-24

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 76

Registration Number: NCT05389293

Locations: 🇺🇸
Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities, Basking Ridge, New Jersey, United States
🇺🇸
Georgetown University (Data Collection Only), Washington, District of Columbia, United States
🇺🇸
Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey, United States

and more 6 locations

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