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

Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

Phase 3

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Ublituximab
Drug: Ibrutinib

First Posted Date: 2014-11-25

Last Posted Date: 2022-05-20

Lead Sponsor: TG Therapeutics, Inc.

Target Recruit Count: 126

Registration Number: NCT02301156

Locations: 🇮🇱
TG Therapeutics Investigational Trial Site, Ashkelon, Israel

Ibrutinib Post Stem Cell Transplantation (SCT) in Double-Hit B-Cell Lymphoma

Phase 2

Terminated

Conditions: Lymphoma

Interventions: Drug: Ibrutinib

First Posted Date: 2014-10-23

Last Posted Date: 2018-12-05

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 1

Registration Number: NCT02272686

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

A Study to Evaluate the Effects of Ibrutinib on Cardiac Repolarization in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Moxifloxacin
Drug: Ibrutinib
Drug: Moxifloxacin-matching placebo
Drug: Ibrutinib-matching placebo

First Posted Date: 2014-10-22

Last Posted Date: 2016-06-06

Lead Sponsor: Janssen Research & Development, LLC

Target Recruit Count: 28

Registration Number: NCT02271438

A Phase I/Ib Safety and Efficacy Study of the PI3K-delta Inhibitor TGR-1202 and Ibrutinib in Patients With CLL or MCL

Phase 1

Completed

Conditions: Mantle Cell Lymphoma
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Interventions: Drug: TGR-1202
Drug: Ibrutinib

First Posted Date: 2014-10-20

Last Posted Date: 2024-11-15

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 45

Registration Number: NCT02268851

Locations: 🇺🇸
Pacific Cancer Care, Monterey, California, United States
🇺🇸
St. Francis Hospital and Cancer Center, Hartford, Connecticut, United States
🇺🇸
Beth Israel Deaconness Medical Center, Boston, Massachusetts, United States

and more 2 locations

Trial of PCI-32765 (BTK Inhibitor) in Combination With Carfilzomib in Relapse/Refractory Mantle Cell Lymphoma

Phase 1

Terminated

Conditions: Lymphoma

Interventions: Drug: Ibrutinib
Drug: Carfilzomib
Behavioral: Phone Calls

First Posted Date: 2014-10-20

Last Posted Date: 2019-02-28

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 8

Registration Number: NCT02269085

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Phase 3

Completed

Conditions: Chronic Lymphocytic Leukemia
Small-Cell Lymphoma

Interventions: Drug: Ibrutinib
Drug: Obinutuzumab
Drug: Chlorambucil

First Posted Date: 2014-10-15

Last Posted Date: 2020-09-21

Lead Sponsor: Pharmacyclics LLC.

Target Recruit Count: 229

Registration Number: NCT02264574

Locations: 🇬🇧
Site Reference ID/Investigator# 0867, Harlow, Essex, United Kingdom
🇦🇺
Site Reference ID/Investigator# 0888, Ballarat, Victoria, Australia
🇦🇹
Site Reference ID/Investigator# 0869, Salzburg, Austria

and more 68 locations

A Phase II Study of Ibrutinib Plus FCR in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia
Leukemia

Interventions: Drug: Ibrutinib
Drug: Fludarabine
Drug: Cyclophosphamide
Drug: Rituximab

First Posted Date: 2014-09-29

Last Posted Date: 2024-07-31

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 85

Registration Number: NCT02251548

Locations: 🇺🇸
West Michigan Cancer Center, Kalamazoo, Michigan, United States
🇺🇸
University of Kansas Cancer Center, Westwood, Kansas, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

and more 5 locations

Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma

Phase 2

Active, not recruiting

Conditions: Contiguous Stage II Mantle Cell Lymphoma
Stage IV Mantle Cell Lymphoma
Noncontiguous Stage II Mantle Cell Lymphoma
Stage III Mantle Cell Lymphoma
Stage I Mantle Cell Lymphoma

Interventions: Drug: ibrutinib
Other: laboratory biomarker analysis

First Posted Date: 2014-09-16

Last Posted Date: 2024-03-12

Lead Sponsor: Northwestern University

Target Recruit Count: 37

Registration Number: NCT02242097

Locations: 🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Northwestern University- Lake Forest Hospital, Lake Forest, Illinois, United States

and more 2 locations

Phase 2 Study to Assess Activity & Safety of Front-line Ibrutinib + Rituximab in Unfit Chronic Lymphocytic Leukemia

Phase 2

Active, not recruiting

Conditions: Chronic Lymphocyte Leukemia
Adult Patients

Interventions: Drug: Ibrutinib
Drug: Rituximab

First Posted Date: 2014-09-05

Last Posted Date: 2023-11-28

Lead Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto

Target Recruit Count: 156

Registration Number: NCT02232386

Locations: 🇮🇹
Unità di Onco-Ematologia - Azienda Ospedaliera - Garibaldi, Catania, Italy
🇮🇹
UO Ematologia - AOU Policlinico di Modena, Modena, Italy
🇮🇹
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova, Reggio Emilia, Italy

and more 33 locations

Ibrutinib and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Phase 1

Completed

Conditions: CD20 Positive
Recurrent Diffuse Large B-Cell Lymphoma
Refractory Diffuse Large B-Cell Lymphoma

Interventions: Drug: Carboplatin
Drug: Etoposide
Drug: Ibrutinib
Drug: Ifosfamide
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Biological: Rituximab

First Posted Date: 2014-08-19

Last Posted Date: 2018-01-26

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 26

Registration Number: NCT02219737

Locations: 🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States

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