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 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

Clinical Trials

A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia

Phase 3

Completed

Conditions: Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia

Interventions: Drug: Zanubrutinib
Drug: Ibrutinib

First Posted Date: 2018-11-07

Last Posted Date: 2025-03-30

Lead Sponsor: BeiGene

Target Recruit Count: 652

Registration Number: NCT03734016

Locations: 🇬🇧
Barts Health Nhs Trust, London, United Kingdom
🇬🇧
Genesiscare Oxford, Waterlooville, United Kingdom
🇺🇸
Carti Cancer Center, Little Rock, Arkansas, United States

and more 112 locations

Ibrutinib + R-CHOP Followed by Ibrutinib Maintenance

Phase 2

Active, not recruiting

Conditions: DLBCL

Interventions: Drug: Ibrutinib

First Posted Date: 2018-11-06

Last Posted Date: 2024-12-20

Lead Sponsor: Fondazione Italiana Linfomi - ETS

Target Recruit Count: 75

Registration Number: NCT03731234

Locations: 🇮🇹
Ospedale di Castelfranco Veneto - Oncoematologia IOV, Castelfranco Veneto, Treviso, Italy
🇮🇹
A.O. SS. Antonio e Biagio e Cesare Arrigo - S.C. Ematologia, Alessandria, Italy
🇮🇹
Università Politecnica delle Marche- Clinica di Ematologia, Ancona, Italy

and more 36 locations

A Study to Evaluate Ibrutinib Retention in Chronic Lymphocytic Leukemia Participants Treated in a Real World Setting

Completed

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Interventions: Drug: Ibrutinib

First Posted Date: 2018-10-25

Last Posted Date: 2022-01-03

Lead Sponsor: Janssen-Cilag S.p.A.

Target Recruit Count: 312

Registration Number: NCT03720561

Locations: 🇮🇹
Div.Clinicizzata EmatologiaconTrapiantodi MidolloOsseo P.O.Rodoligo AOUPoliclinico-Vittorio Emanuele, Catania, Italy
🇮🇹
S.C. Ematologia Azienda Ospedaliera S. Croce e Carle, Cuneo, Italy
🇮🇹
Unità Funzionale di Ematologia Azienda ospedaliero-universitaria Careggi, Firenze, Italy

and more 36 locations

Ibrutinib, Rituximab, Venetoclax, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Mantle Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: Cyclophosphamide
Drug: Cytarabine
Drug: Dexamethasone
Drug: Doxorubicin Hydrochloride
Drug: Ibrutinib
Drug: Methotrexate
Biological: Rituximab
Drug: Venetoclax
Drug: Vincristine Sulfate

First Posted Date: 2018-10-18

Last Posted Date: 2025-05-16

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 51

Registration Number: NCT03710772

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Ibrutinib lead-in Followed by Venetoclax Plus Ibrutinib in Patients With RR CLL

Phase 2

Active, not recruiting

Conditions: Relapsed/Refractory Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Leukemia

Interventions: Drug: Ibrutinib
Drug: Venetoclax

First Posted Date: 2018-10-16

Last Posted Date: 2025-04-27

Lead Sponsor: Swiss Group for Clinical Cancer Research

Target Recruit Count: 30

Registration Number: NCT03708003

Locations: 🇨🇭
Kantonsspital Aarau, Aarau, Switzerland
🇨🇭
IOSI - Ospedale San Giovanni, Bellinzona, Switzerland
🇨🇭
Universitätsspital Basel, Basel, Switzerland

and more 8 locations

Ibrutinib With Rituximab and Lenalidomide for Patients With Recurrent/Refractory Primary or Secondary Central Nervous System Lymphoma (PCNSL/SCNSL)

Phase 1

Active, not recruiting

Conditions: Primary Central Nervous System Lymphoma (PCNSL)
Secondary Central Nervous System Lymphoma (SCNSL)

Interventions: Drug: Ibrutinib
Drug: Lenalidomide
Drug: Rituximab

First Posted Date: 2018-10-11

Last Posted Date: 2025-03-21

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 25

Registration Number: NCT03703167

Locations: 🇺🇸
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States

and more 4 locations

Study of Ibrutinib in Combination With Revlimid/Dexamethasone in Relapsed/Refractory Multiple Myeloma

Phase 1

Active, not recruiting

Conditions: Multiple Myeloma in Relapse
Multiple Myeloma
Refractory Multiple Myeloma

Interventions: Drug: Ibrutinib
Drug: Lenalidomide
Drug: Dexamethasone

First Posted Date: 2018-10-11

Last Posted Date: 2024-10-23

Lead Sponsor: Alliance Foundation Trials, LLC.

Target Recruit Count: 14

Registration Number: NCT03702725

Locations: 🇺🇸
Loyola University Medical Center, Maywood, Illinois, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
The Ohio State University Wexner Medical Center/James Cancer Hospital, Columbus, Ohio, United States

and more 2 locations

Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia

Phase 3

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma

Interventions: Procedure: Biospecimen Collection
Procedure: Bone Marrow Biopsy
Procedure: Computed Tomography
Drug: Ibrutinib
Biological: Obinutuzumab
Other: Quality-of-Life Assessment
Drug: Venetoclax

First Posted Date: 2018-10-10

Last Posted Date: 2025-05-09

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 720

Registration Number: NCT03701282

Locations: 🇺🇸
The Medical Center of Aurora, Aurora, Colorado, United States
🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States

and more 864 locations

MALIBU Trial - Combination of Ibrutinib and Rituximab in Untreated Marginal Zone Lymphomas

Phase 2

Active, not recruiting

Conditions: Marginal Zone Lymphoma
Nodal Marginal Zone Lymphoma
Splenic Marginal Zone Lymphoma

Interventions: Drug: Ibrutinib
Drug: Rituximab

First Posted Date: 2018-10-05

Last Posted Date: 2024-08-28

Lead Sponsor: International Extranodal Lymphoma Study Group (IELSG)

Target Recruit Count: 175

Registration Number: NCT03697512

Locations: 🇫🇷
CHU de Tours - Hôpital Bretonneau, Tours, Cedex 01, France
🇮🇹
Ospedale San Raffaele, Milano, MI, Italy
🇮🇹
Università degli Studi di Roma La Sapienza, Roma, Italy

and more 33 locations

Ibrutinib Plus Rituximab for cGVHD Following Allo-SCT

Phase 1

Terminated

Conditions: Chronic Graft-versus-host-disease

Interventions: Drug: Ibrutinib
Drug: Rituximab

First Posted Date: 2018-10-01

Last Posted Date: 2023-11-28

Lead Sponsor: Dartmouth-Hitchcock Medical Center

Target Recruit Count: 2

Registration Number: NCT03689894

Locations: 🇺🇸
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

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