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 Mavorixafor in Combination With Ibrutinib in Participants With Waldenstrom's Macroglobulinemia (WM) Whose Tumors Express Mutations in MYD88 and CXCR4

Phase 1

Completed

Conditions: Waldenstrom's Macroglobulinemia

Interventions: Drug: Mavorixafor
Drug: Ibrutinib

First Posted Date: 2020-02-18

Last Posted Date: 2024-08-27

Lead Sponsor: X4 Pharmaceuticals

Target Recruit Count: 16

Registration Number: NCT04274738

Locations: 🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Mass General Hospital Cancer Center, Boston, Massachusetts, United States
🇬🇷
University of Athens, Athens, Greece

and more 2 locations

Ibrutinib + Venetoclax in Untreated WM

Phase 2

Active, not recruiting

Conditions: Waldenstrom Macroglobulinemia
MYD88 Gene Mutation

Interventions: Drug: IBRUTINIB
Drug: Venetoclax

First Posted Date: 2020-02-17

Last Posted Date: 2025-02-11

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 45

Registration Number: NCT04273139

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

Efficacy and Safety of Carfilzomib in Combination With Ibrutinib vs Ibrutinib in Waldenström's Macroglobulinemia

Phase 2

Active, not recruiting

Conditions: Waldenstrom Macroglobulinemia

Interventions: Drug: Carfilzomib + Ibrutinib
Drug: Ibrutinib

First Posted Date: 2020-02-10

Last Posted Date: 2025-04-04

Lead Sponsor: Christian Buske

Target Recruit Count: 99

Registration Number: NCT04263480

Locations: 🇦🇹
Uniklinikum Salzburg, Salzburg, Austria
🇩🇪
Kath. St.-Johannes-Gesellschaft Dortmund gGmbH, Dortmund, Germany
🇩🇪
OncoResearch Lerchenfeld GmbH, Hamburg, Germany

and more 17 locations

Ibrutinib and Rituxan for Chronic GVHD

Phase 2

Terminated

Conditions: Graft Vs Host Disease

Interventions: Drug: Rituximab
Drug: Ibrutinib

First Posted Date: 2020-01-21

Last Posted Date: 2024-12-13

Lead Sponsor: Northside Hospital, Inc.

Target Recruit Count: 15

Registration Number: NCT04235036

Locations: 🇺🇸
Northside Hospital, Atlanta, Georgia, United States

Daratumumab and Ibrutinib for the Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia, DIRECT Study

Phase 2

Active, not recruiting

Conditions: Recurrent Small Lymphocytic Lymphoma
Refractory Small Lymphocytic Lymphoma
Recurrent Chronic Lymphocytic Leukemia
Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Refractory Chronic Lymphocytic Leukemia

Interventions: Biological: Daratumumab
Drug: Ibrutinib

First Posted Date: 2020-01-18

Last Posted Date: 2024-08-23

Lead Sponsor: Mayo Clinic

Target Recruit Count: 11

Registration Number: NCT04230304

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

A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma

Phase 3

Active, not recruiting

Conditions: Marginal Zone Lymphoma

Interventions: Drug: Ibrutinib
Drug: Rituximab
Other: Placebo

First Posted Date: 2019-12-26

Last Posted Date: 2024-07-23

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 23

Registration Number: NCT04212013

Locations: 🇺🇸
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
🇺🇸
George Washington Cancer Center, Washington, District of Columbia, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States

and more 7 locations

Duvelisib for Ibrutinib-Resistant Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Phase 2

Terminated

Conditions: Chronic Lymphocytic Leukemia (CLL)
Small Lymphocytic Leukemia (SLL)

Interventions: Drug: Duvelisib
Drug: Ibrutinib

First Posted Date: 2019-12-24

Last Posted Date: 2022-03-09

Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Target Recruit Count: 3

Registration Number: NCT04209621

Locations: 🇺🇸
National Institutes of Health Clinical Center, Bethesda, Maryland, United States

A Trial to Compare Ibrutinib Versus Lenalidomide in Combination With MRE-chemotherapy for Adult Patients With Recurrent/Refractory Primary Central Nervous System Lymphoma (PCNSL)

Phase 2

Recruiting

Conditions: Recurrent/RefractoryPrimary Central Nervous System Lymphoma (PCNSL)

Interventions: Drug: Ibrutinib
Drug: Lenalidomide
Drug: Methotrexate
Drug: Rituximab
Drug: Etoposide
Drug: PEGylated recombinant human granulocyte colony

First Posted Date: 2019-10-17

Last Posted Date: 2021-07-16

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Target Recruit Count: 120

Registration Number: NCT04129710

Locations: 🇨🇳
Department of Hematology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China/Zhejiang Province, China

Observational Study of CLL/SLL Treatment and Ibrutinib Treatment of CLL/SLL in Routine Clinical Practice

Conditions: Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia

First Posted Date: 2019-09-18

Last Posted Date: 2019-09-18

Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Target Recruit Count: 580

Registration Number: NCT04094051

Locations: 🇨🇳
the First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China

A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM)

Phase 2

Completed

Conditions: Waldenstrom Macroglobulinemia

Interventions: Drug: Ibrutinib
Drug: Rituximab

First Posted Date: 2019-08-20

Last Posted Date: 2025-04-27

Lead Sponsor: Janssen Pharmaceutical K.K.

Target Recruit Count: 16

Registration Number: NCT04062448

Locations: 🇯🇵
Matsuyama Red Cross Hospital, Matsuyama-City, Japan
🇯🇵
Kameda Medical Center, Chiba, Japan
🇯🇵
National Cancer Center Hospital, Chuo Ku, Japan

and more 6 locations

Drug Development Updates

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