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 Treating Patients With Refractory or Relapsed Lymphoma After Donor Stem Cell Transplant

Phase 2

Completed

Conditions: Blastoid Variant Mantle Cell Lymphoma
Refractory Chronic Lymphocytic Leukemia
Refractory Follicular Lymphoma
Recurrent Chronic Lymphocytic Leukemia
Recurrent Hodgkin Lymphoma
Recurrent Follicular Lymphoma
Refractory Hodgkin Lymphoma
Recurrent Mantle Cell Lymphoma
Refractory Mantle Cell Lymphoma

Interventions: Drug: Ibrutinib
Other: Laboratory Biomarker Analysis

First Posted Date: 2016-08-17

Last Posted Date: 2023-10-23

Lead Sponsor: Vanderbilt-Ingram Cancer Center

Target Recruit Count: 23

Registration Number: NCT02869633

Locations: 🇺🇸
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

and more 2 locations

Ibrutinib in Previously Untreated Binet Stage A Chronic Lymphocytic Leukemia With Risk of Disease Progression

Phase 3

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Placebo
Drug: Ibrutinib

First Posted Date: 2016-08-11

Last Posted Date: 2022-11-07

Lead Sponsor: German CLL Study Group

Target Recruit Count: 515

Registration Number: NCT02863718

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

Identification of Biomarkers That Are Predictive of Early Ibrutinib Treatment Failure in High Risk TP53 Mutated Chronic Lymphocytic Leukemia

Active, not recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Ibrutinib

First Posted Date: 2016-07-11

Last Posted Date: 2024-04-22

Lead Sponsor: Oncology Institute of Southern Switzerland

Target Recruit Count: 56

Registration Number: NCT02827617

Locations: 🇮🇹
Ospedale San Raffaele, Milano, Italy
🇮🇹
Department of Medical and Surgical Sciences, section of Hematology, Modena, Italy
🇮🇹
Ematologia, Ospedale di Circolo e Fondazione Macchi, Varese, Italy

and more 10 locations

Ibrutinib in Treating Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Phase 2

Active, not recruiting

Conditions: Classical Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Recurrent Hodgkin Lymphoma

Interventions: Drug: Ibrutinib
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

First Posted Date: 2016-07-06

Last Posted Date: 2023-09-14

Lead Sponsor: Barbara Ann Karmanos Cancer Institute

Target Recruit Count: 35

Registration Number: NCT02824029

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
University of Tennessee, Knoxville, Tennessee, United States
🇺🇸
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States

and more 1 locations

Study of Pts With Philadelphia Chromosome-Pos ALL With Comb of Ibrutinib, Dasatinib, and Prednisone

Phase 1

Withdrawn

Conditions: Acute Lymphoblastic Leukemia

Interventions: Drug: Ibrutinib
Drug: Dasatinib
Drug: Prednisone

First Posted Date: 2016-06-28

Last Posted Date: 2018-01-31

Lead Sponsor: University of Utah

Registration Number: NCT02815059

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States

A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)

Phase 2

Completed

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Ibrutinib

First Posted Date: 2016-06-16

Last Posted Date: 2020-02-27

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 11

Registration Number: NCT02801578

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

ACY-1215 in Combination With BCR Pathway Inhibitors in Relapsed CLL

Phase 1

Active, not recruiting

Conditions: Recurrent Chronic Lymphoid Leukemia

Interventions: Drug: ACY-1215
Drug: Ibrutinib
Drug: Idelalisib

First Posted Date: 2016-06-01

Last Posted Date: 2024-12-20

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 3

Registration Number: NCT02787369

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States

AZD2014 Plus Novel Anti-Cancer Agents in Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Phase 1

Withdrawn

Conditions: Core: Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Module 1: Non-GCB Diffuse Large B-Cell Lymphoma

Interventions: Drug: AZD2014
Drug: Ibrutinib

First Posted Date: 2016-05-24

Last Posted Date: 2016-09-15

Lead Sponsor: AstraZeneca

Registration Number: NCT02780830

A Study of Itacitinib (INCB039110) in Combination With Ibrutinib in Subjects With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Phase 1

Completed

Conditions: Lymphoma

Interventions: Drug: itacitinib
Drug: ibrutinib

First Posted Date: 2016-05-03

Last Posted Date: 2023-06-15

Lead Sponsor: Incyte Corporation

Target Recruit Count: 33

Registration Number: NCT02760485

Locations: 🇺🇸
LAC-USC Medical Center/Kenneth Norris Jr Cancer Hospital, Los Angeles, California, United States
🇺🇸
Pacific Shores Medical Group, Long Beach, California, United States
🇺🇸
Mayo Clinic Arizona, Scottsdale, Arizona, United States

and more 18 locations

Intravenous BI 836826 in Combination With Ibrutinib in Relapsed/Refractory CLL Patients Who Have Been Pre-treated With at Least One Prior Line of Systemic Therapy, and Who Are Eligible for Treatment With Ibrutinib

Phase 1

Completed

Conditions: Leukemia, Lymphocytic, Chronic, B-Cell

Interventions: Drug: BI 836826
Drug: Ibrutinib

First Posted Date: 2016-05-03

Last Posted Date: 2020-09-29

Lead Sponsor: Boehringer Ingelheim

Target Recruit Count: 7

Registration Number: NCT02759016

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Oregon Health and Sciences University, Portland, Oregon, United States
🇺🇸
City of Hope, Duarte, California, United States

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