Ibrutinib
- Generic Name
- Ibrutinib
- Brand Names
- Imbruvica
- Drug Type
- Small Molecule
- Chemical Formula
- C25H24N6O2
- CAS Number
- 936563-96-1
- Unique Ingredient Identifier
- 1X70OSD4VX
- Background
Ibrutinib is a small molecule that acts as an irreversible potent inhibitor of Burton's tyrosine kinase. It is designated as a targeted covalent drug and presented as a promising activity in B-cell malignancies in clinical trials. Ibrutinib was developed by Pharmacyclics Inc and was first approved by the FDA in November 2013 for the treatment of mantle cell lymphoma (MCL) under accelerated approval; however, in April 2023, the drug manufacturer withdrew the accelerated approvals for ibrutinib in the US.
Ibrutinib was approved by the EMA in October 2014 and by Health Canada in November 2014. It is currently approved for the treatment of various conditions, such as chronic lymphocytic leukemia (CLL), Waldenström's Macroglobulinemia, and chronic graft versus host disease (cGVHD) in August 2017. Notably, ibrutinib became the first FDA-approved cGVHD treatment for children in August 2017.
- Indication
Ibrutinib is indicated for the treatment of the following conditions.
Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
Waldenström's macroglobulinemia
Chronic graft-versus-host disease (cGVHD)
Mantle cell lymphoma (MCL)
Marginal zone lymphoma (MZL)
- Associated Conditions
- Chronic Graft-Versus-Host Disease, Chronic Lymphocytic Leukemia, Marginal Zone Lymphoma (MZL), Refractory Mantle Cell Lymphoma, Relapsed Mantle Cell Lymphoma, Small Lymphocytic Lymphoma, Steroid-dependent chronic graft-versus-host disease, Waldenström's Macroglobulinemia (WM), Steroid refractory Chronic graft versus host disease
A Rollover Study for Continued Study Treatment and Ongoing Safety Monitoring
- Conditions
- Leukemia, Myeloid, AcuteLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Non-HodgkinMyelodysplastic SyndromesNeoplasmsSolid Tumor, AdultMetastatic Castration-resistant Prostate Cancer (mCRPC)
- Interventions
- First Posted Date
- 2025-01-23
- Last Posted Date
- 2025-04-27
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 80
- Registration Number
- NCT06788509
- Locations
- 🇨🇳
Chang Kung Memorial Hospital, Kaohsiung City, Taiwan
🇧🇪Ghent University Hospital, Gent, Belgium
🇫🇷Hopital Claude Huriez, Lille, France
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
- Conditions
- Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsRecurrent High Grade B-Cell Lymphoma, Not Otherwise SpecifiedRefractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRefractory T-Cell/Histiocyte-Rich Large B-Cell LymphomaRecurrent Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent T-Cell/Histiocyte-Rich Large B-Cell LymphomaRecurrent Diffuse Large B-Cell LymphomaRecurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell TypeRecurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRefractory Diffuse Large B-Cell Lymphoma
- Interventions
- Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyProcedure: Magnetic Resonance ImagingProcedure: Positron Emission Tomography
- First Posted Date
- 2024-10-21
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 120
- Registration Number
- NCT06649812
Epcoritamab Plus Ibrutinib for the Treatment of Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
- Conditions
- Recurrent Diffuse Large B-Cell LymphomaRecurrent Grade 3b Follicular LymphomaRecurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRecurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsRecurrent High Grade B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent Primary Mediastinal Large B-Cell LymphomaRecurrent Transformed Non-Hodgkin LymphomaRefractory Diffuse Large B-Cell LymphomaRefractory Grade 3b Follicular LymphomaRefractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyProcedure: Positron Emission Tomography
- First Posted Date
- 2024-08-02
- Last Posted Date
- 2025-05-01
- Lead Sponsor
- Yazeed Sawalha
- Target Recruit Count
- 38
- Registration Number
- NCT06536049
- Locations
- 🇺🇸
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States
🇺🇸Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma
- First Posted Date
- 2024-07-01
- Last Posted Date
- 2024-07-01
- Lead Sponsor
- Christian Schmidt, MD
- Target Recruit Count
- 150
- Registration Number
- NCT06482684
- Locations
- 🇩🇪
University Hospital of Mainz, Mainz, Germany
🇩🇪Klinikum der Universität München, Munich, Germany
Glofitamab Plus Ibrutinib With Obinutuzumab for the Treatment of Patients With Mantle Cell Lymphoma
- Conditions
- Mantle Cell Lymphoma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow BiopsyProcedure: Computed TomographyProcedure: EchocardiographyProcedure: FDG-Positron Emission TomographyProcedure: Magnetic Resonance Imaging
- First Posted Date
- 2024-04-10
- Last Posted Date
- 2025-04-20
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 27
- Registration Number
- NCT06357676
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia
- Conditions
- Leukemia, Lymphocytic, Chronic, B-Cell
- Interventions
- Behavioral: Individual Physical Activity Intervention (IPAI)
- First Posted Date
- 2024-03-08
- Last Posted Date
- 2025-04-04
- Lead Sponsor
- Janssen Cilag S.A.S.
- Target Recruit Count
- 256
- Registration Number
- NCT06299540
- Locations
- 🇫🇷
Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France
Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant
- Conditions
- Hematopoietic and Lymphatic System NeoplasmChronic Graft Versus Host Disease
- Interventions
- Procedure: Echocardiography
- First Posted Date
- 2024-02-22
- Last Posted Date
- 2025-01-08
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 40
- Registration Number
- NCT06271616
- Locations
- 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States
Is Ibrutinib-related Atrial Fibrillation Dose Dependent
- Conditions
- Hematological MalignancyAtrial Fibrillation
- First Posted Date
- 2024-01-25
- Last Posted Date
- 2024-03-05
- Lead Sponsor
- University Hospital, Caen
- Target Recruit Count
- 18000
- Registration Number
- NCT06224452
- Locations
- 🇫🇷
Caen University Hospital, Department of Pharmacology, Caen, Normandie, France
A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/BELLWAVE-011)
- Conditions
- Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma
- Interventions
- First Posted Date
- 2023-11-18
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Target Recruit Count
- 1200
- Registration Number
- NCT06136559
- Locations
- 🇺🇸
USA Mitchell Cancer Institute ( Site 0014), Mobile, Alabama, United States
🇺🇸Florida Cancer Specialists - East ( Site 7002), West Palm Beach, Florida, United States
🇺🇸Arizona Oncology Associates - NAHOA ( Site 8007), Prescott, Arizona, United States
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
- Conditions
- Non-hodgkin Lymphoma
- Interventions
- First Posted Date
- 2023-08-21
- Last Posted Date
- 2025-01-14
- Lead Sponsor
- Canadian Cancer Trials Group
- Target Recruit Count
- 30
- Registration Number
- NCT05998642
- Locations
- 🇨🇦
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
🇨🇦The Research Institute of the McGill University, Montreal, Quebec, Canada
🇨🇦BCCA - Vancouver, Vancouver, British Columbia, Canada
Drug Development Updates
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