Tirabrutinib

DRUG12 trials

Sponsors

Gilead Sciences, Ono Pharmaceutical Co. Ltd, Kyorin University

Conditions

B-cell MalignanciesChronic Lymphocytic LeukaemiaChronic Lymphocytic LeukemiaChronic Spontaneous UrticariaNon Hodgkins LymphomaPrimary CNS LymphomaPrimary Central Nervous System LymphomaPrimary Central Nervous System Lymphoma (PCNSL)

Phase 1

Study to Evaluate the Safety and Tolerability of Tirabrutinib (ONO/GS-4059) Given as Monotherapy in Participants With Relapsed/Refractory NHL and CLL

CompletedNCT01659255

Gilead SciencesChronic Lymphocytic Leukaemia, Non Hodgkins Lymphoma

Start: 2012-08-17End: 2016-01-11Updated: 2021-03-16

Study to Assess the Long-term Safety and Efficacy of Tirabrutinib in Adults With Relapsed/Refractory B-cell Malignancies

CompletedNCT02457559

Gilead SciencesRelapsed/Refractory B-cell Malignancies

Start: 2015-09-10End: 2020-12-30Updated: 2022-03-24

Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination With Other Targeted Anti-cancer Therapies in Adults With B-cell Malignancies

TerminatedNCT02457598

Gilead SciencesB-cell Malignancies

Start: 2015-06-16End: 2024-09-25Updated: 2025-06-17

Study to Evaluate Safety and Pharmacokinetics of GS-4059 (Tirabrutinib) in Healthy Volunteers and Participants With Rheumatoid Arthritis (RA)

CompletedNCT02626026

Gilead SciencesRheumatoid Arthritis

Start: 2016-01-26End: 2016-09-01Updated: 2020-09-09

A Study to Investigate the Pharmacokinetics of Tirabrutinib in Participants With Mild, Moderate, and Severe Hepatic Impairment Compared to Healthy Participants

RecruitingNCT07198087

Ono Pharmaceutical Co. LtdPrimary Central Nervous System Lymphoma (PCNSL)

Start: 2025-10-01End: 2026-12-31Target: 32Updated: 2025-10-17

Phase 2

Study to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib and Idelalisib With and Without Obinutuzumab in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

CompletedNCT02968563

Gilead SciencesChronic Lymphocytic Leukemia

Start: 2016-12-13End: 2021-01-14Updated: 2022-01-21

Safety and Efficacy of the Combination of Tirabrutinib and Entospletinib With and Without Obinutuzumab in Adults With Chronic Lymphocytic Leukemia (CLL)

CompletedNCT02983617

Gilead SciencesChronic Lymphocytic Leukemia

Start: 2017-04-06End: 2020-10-01Updated: 2021-12-21

Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome

CompletedNCT03100942

Gilead SciencesSjogren's Syndrome

Start: 2017-05-01End: 2019-10-02Updated: 2020-10-23

Study to Evaluate the Efficacy, Safety, and Tolerability of Tirabrutinib in Participants With Antihistamine-Resistant Chronic Spontaneous Urticaria

WithdrawnNCT04827589

Gilead SciencesChronic Spontaneous Urticaria

Start: 2021-07-31End: 2022-09-30Updated: 2021-07-28

Study of Tirabrutinib (ONO-4059) in Patients With Primary Central Nervous System Lymphoma (PROSPECT Study)

Active, not recruitingNCT04947319

Ono Pharmaceutical Co. LtdPrimary CNS Lymphoma, Refractory Primary Central Nervous System Lymphoma

Start: 2021-12-29End: 2027-03-31Updated: 2026-03-30

Tirabrutinib Maintenance Versus Placebo in Patients With Primary CNS Lymphoma in Complete Remission (JCOG2104)

RecruitingNCT06940791

Kyorin UniversityPrimary Central Nervous System Lymphoma

Start: 2023-10-06End: 2030-02-28Target: 92Updated: 2025-04-23

Phase 3

IGNITE: Study of Tirabrutinib vs Rituximab/Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)

RecruitingNCT07104032

Ono Pharmaceutical Co. LtdRelapsed/Refractory Primary Central Nervous System Lymphoma

Start: 2026-03-01End: 2029-12-01Target: 132Updated: 2026-03-11

Related Papers

Trial in progress: A phase 3, multi-regional, open-label, randomized study of tirabrutinib vs rituximab and temozolomide in participants with Relapsed/Refractory primary central nervous system lymphoma

Blood2025-11-03

CTNI-39. TIRABRUTINIB FOR THE TREATMENT OF RELAPSED OR REFRACTORY PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA: EFFICACY AND SAFETY FROM THE PHASE II PROSPECT STUDY

Neuro-Oncology2025-11-01

Tirabrutinib for the treatment of relapsed or refractory primary central nervous system lymphoma: Efficacy and safety from the phase II PROSPECT study.

Journal of Clinical Oncology2025-05-281 citations

Monitoring of molecular responses to tirabrutinib in a cohort of exceptional responders with relapsed/refractory mantle cell lymphoma

eJHaem2024-06-241 citations

A multi-center, open-label, randomized study to explore efficacy and safety of baricitinib in active primary Sjogren’s syndrome patients

Trials2023-02-159 citations

Successful Retreatment With Venetoclax in a Patient With Chronic Lymphocytic Leukemia

HemaSphere2022-07-154 citations

Safety and efficacy of filgotinib, lanraplenib and tirabrutinib in Sjögren’s syndrome: a randomized, phase 2, double-blind, placebo-controlled study

Lara D. Veeken2022-04-0465 citations

Abstract 3036: Intracellular phospho-flow reveals novel insights to pathway modulation by tirabrutinib in combination with entospletinib and obinutuzumab

Cancer Research2020-08-15

Phase Ib Study of Tirabrutinib in Combination with Idelalisib or Entospletinib in Previously Treated Chronic Lymphocytic Leukemia

Clinical Cancer Research2020-03-1057 citations

A Prospective, Open-Label, Multicenter, Phase 2 Trial to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib (ONO/GS-4059) and Idelalisib with and without Obinutuzumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Blood2019-11-137 citations

A Prospective, Open-Label, Multicenter, Phase 2 Trial to Evaluate the Safety and Efficacy of the Combination of Tirabrutinib (ONO/GS-4059) and Entospletinib with and without Obinutuzumab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)

Blood2019-11-136 citations

Significant Progress Made in CLL, But ‘Home Run’ Therapy Remains Elusive

Oncology Times2019-07-11

Updated Preliminary Results of a Phase 1b Dose Escalation and Dose Expansion Study of Tirabrutinib Alone or in Combination with Idelalisib or Entospletinib in Patients with Previously Treated Chronic Lymphocytic Leukemia

Blood2018-11-291 citations

Updated Preliminary Results of a Phase 1b Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination with Idelalisib in Patients with B-Cell Lymphoma

Blood2018-11-29

Updated Preliminary Results of a Phase 1b Dose Escalation and Dose Expansion Study of Tirabrutinib in Combination with Entospletinib in Patients with B-Cell Lymphoma

Blood2018-11-29

PRELIMINARY RESULTS OF A PHASE 1B STUDY OF TIRABRUTINIB (GS‐4059/ONO‐4059) IN COMBINATION WITH ENTOSPLETINIB IN PATIENTS WITH B‐CELL MALIGNANCIES

Hematological Oncology2017-06-011 citations

Preliminary results of a phase Ib study of GS-4059 in combination with entospletinib in patients with B-cell malignancies.

Journal of Clinical Oncology2017-05-20

PI3Kδ inhibitor idelalisib in combination with BTK inhibitor ONO/GS-4059 in diffuse large B cell lymphoma with acquired resistance to PI3Kδ and BTK inhibitors

PLoS ONE2017-02-0850 citations

Long-Term Follow-up with GS-4059, a Selective Irreversible BTK Inhibitor, in Patients with Relapsed and Refractory Chronic Lymphocytic Leukemia

Blood2016-12-022 citations

Evaluation of Idelalisib with B-Cell Receptor or Orthogonal Pathway Inhibitors in Diffuse Large B-Cell Lymphoma Cell Lines in Vitro and In Vivo

Blood2016-12-022 citations

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