Ibrutinib

Generic Name: Ibrutinib

Brand Names: Imbruvica

Drug Type: Small Molecule

Chemical Formula: C_₂₅H_₂₄N_₆O_₂

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 ...

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

Associated Therapies: -

Clinical Trials

Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma

Phase 2

Not yet recruiting

Conditions: High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified
Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type

Interventions: Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Drug: Ibrutinib
Drug: Lenalidomide
Procedure: Magnetic Resonance Imaging
Biological: Obinutuzumab
Procedure: Positron Emission Tomography
Drug: Prednisone
Drug: Venetoclax

First Posted Date: 2024-10-21

Last Posted Date: 2024-10-21

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

Phase 1

Not yet recruiting

Conditions: Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified
Recurrent Grade 3b Follicular Lymphoma
Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified
Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
Recurrent Diffuse Large B-Cell Lymphoma
Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
Recurrent Primary Mediastinal Large B-Cell Lymphoma
Recurrent Transformed Non-Hodgkin Lymphoma
Refractory Grade 3b Follicular Lymphoma
Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Biological: Epcoritamab
Drug: Ibrutinib
Procedure: Positron Emission Tomography

First Posted Date: 2024-08-02

Last Posted Date: 2024-08-02

Lead Sponsor: Yazeed Sawalha

Target Recruit Count: 38

Registration Number: NCT06536049

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
🇺🇸
University of Minnesota/Masonic Cancer Center, Minneapolis, Minnesota, United States

CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma

Phase 2

Recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: KTE-X19
Drug: Ibrutinib

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

Phase 1

Not yet recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Procedure: Echocardiography
Procedure: FDG-Positron Emission Tomography
Biological: Glofitamab
Drug: Ibrutinib
Procedure: Magnetic Resonance Imaging
Biological: Obinutuzumab

First Posted Date: 2024-04-10

Last Posted Date: 2024-04-10

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

Recruiting

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Interventions: Behavioral: Individual Physical Activity Intervention (IPAI)
Drug: Ibrutinib

First Posted Date: 2024-03-08

Last Posted Date: 2024-12-09

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

Phase 2

Recruiting

Conditions: Hematopoietic and Lymphatic System Neoplasm
Chronic Graft Versus Host Disease

Interventions: Procedure: Biospecimen Collection
Procedure: Echocardiography
Drug: Ibrutinib

First Posted Date: 2024-02-22

Last Posted Date: 2024-12-18

Lead Sponsor: Mayo Clinic

Target Recruit Count: 40

Registration Number: NCT06271616

Locations: 🇺🇸
Mayo Clinic in Florida, Jacksonville, Florida, United States

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)

Phase 3

Recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Drug: Nemtabrutinib
Drug: Ibrutinib
Drug: Acalabrutinib

First Posted Date: 2023-11-18

Last Posted Date: 2024-12-05

Lead Sponsor: Merck Sharp & Dohme LLC

Target Recruit Count: 1200

Registration Number: NCT06136559

Locations: 🇨🇿
Vseobecna fakultni nemocnice v Praze-I. Interní klinika - klinika hematologie ( Site 0302), Praha 2, Czechia
🇲🇾
Queen Elizabeth Hospital ( Site 1603), Kota Kinabalu, Sabah, Malaysia
🇲🇽
Centro de Infusion Superare ( Site 2602), Ciudad de México, Distrito Federal, Mexico

and more 147 locations

Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma

Phase 2

Recruiting

Conditions: Non-hodgkin Lymphoma

Interventions: Drug: Methotrexate
Drug: Rituximab (where available)
Drug: Ibrutinib

First Posted Date: 2023-08-21

Last Posted Date: 2024-11-12

Lead Sponsor: Canadian Cancer Trials Group

Target Recruit Count: 30

Registration Number: NCT05998642

Locations: 🇨🇦
The Research Institute of the McGill University, Montreal, Quebec, Canada
🇨🇦
BCCA - Vancouver, Vancouver, British Columbia, Canada
🇨🇦
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada

and more 2 locations

A Study to Customize Ibrutinib Treatment Regimens for Participants With Previously Untreated Chronic Lymphocytic Leukemia

Phase 2

Recruiting

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell
Small Lymphocytic Lymphoma

Interventions: Drug: Ibrutinib
Drug: Venetoclax

First Posted Date: 2023-07-27

Last Posted Date: 2024-12-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 320

Registration Number: NCT05963074

Locations: 🇺🇸
Cancer and Blood Specialty Clinic, Los Alamitos, California, United States
🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
🇮🇹
ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy

and more 68 locations

Genetically Risk-Stratified Venetoclax, Ibrutinib, Rituximab (± Navitoclax) in Relapsed/Refractory Mantle Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Mantle Cell Lymphoma Refractory

Interventions: Drug: Ibrutinib
Drug: Venetoclax
Drug: Navitoclax
Drug: Rituximab

First Posted Date: 2023-05-18

Last Posted Date: 2024-08-12

Lead Sponsor: Peter MacCallum Cancer Centre, Australia

Target Recruit Count: 40

Registration Number: NCT05864742

Locations: 🇦🇺
Flinders Medical Centre, Bedford Park, South Australia, Australia
🇦🇺
Peter MacCallum Cancer Centre, Parkville, Victoria, Australia
🇦🇺
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Drug Development Updates

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