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

Associated Therapies: -

Clinical Trials

Ibrutinib in Patients With Refractory/Relapsed Non-GCB Diffuse Large B-cell Lymphoma Non-candidates to ASCT

Phase 2

Completed

Conditions: Diffuse Large B-Cell Lymphoma

Interventions: Drug: Ibrutinib
Drug: Rituximab
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Dexamethasone

First Posted Date: 2016-02-26

Last Posted Date: 2024-10-10

Lead Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Target Recruit Count: 64

Registration Number: NCT02692248

Locations: 🇪🇸
Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain
🇪🇸
Hospital Universitario Son Espases, Palma, Islas Baleares, Spain
🇪🇸
Hospital Universitario Donostia, Donostia San Sebastian, Guipúzcoa, Spain

and more 14 locations

Combination of PCI-32765 With Obinutuzumab in Untreated Follicular Lymphoma

Phase 2

Conditions: Indolent Non-Hodgkin Lymphoma

Interventions: Drug: Ibrutinib
Drug: GA 101

First Posted Date: 2016-02-24

Last Posted Date: 2021-05-07

Lead Sponsor: Ludwig-Maximilians - University of Munich

Target Recruit Count: 98

Registration Number: NCT02689869

Locations: 🇩🇪
Klinikum der Universität München, München, Bavaria, Germany

Sequential Regimen of Bendamustin-Debulking Followed by Ofatumumab and Ibrutinib in CLL Patients (CLL2-BIO)

Phase 2

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Bendamustine
Drug: Ofatumumab
Drug: Ibrutinib

First Posted Date: 2016-02-23

Last Posted Date: 2020-06-11

Lead Sponsor: German CLL Study Group

Target Recruit Count: 66

Registration Number: NCT02689141

Locations: 🇩🇪
German CLL Study Group, Cologne, Germany

Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of MCL

Phase 2

Active, not recruiting

Conditions: Mantle Cell Lymphoma

Interventions: Drug: IBRUTINIB
Drug: Rituximab

First Posted Date: 2016-02-15

Last Posted Date: 2024-02-26

Lead Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Target Recruit Count: 50

Registration Number: NCT02682641

Locations: 🇪🇸
Hospital Universitario Mútua Terrassa, Terrassa, Barcelona, Spain
🇪🇸
Hospital General Universitario Santa Lucía, Cartagena, Murcia, Spain
🇪🇸
Hospital Costa del Sol, Marbella, Málaga, Spain

and more 12 locations

Multicenter Study of Pacritinib Combined With Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Phase 1

Withdrawn

Conditions: Chronic Lymphocytic Leukemia
Lymphoma, Small Lymphocytic

Interventions: Drug: Pacritinib
Drug: Ibrutinib

First Posted Date: 2016-02-09

Last Posted Date: 2017-09-06

Lead Sponsor: University of Michigan Rogel Cancer Center

Registration Number: NCT02677948

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States