Entospletinib

DRUG11 trials

Sponsors

Gilead Sciences, Alexey Danilov, MD, The Lymphoma Academic Research Organisation, Kronos Bio

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaAnemiaB-Cell Prolymphocytic LeukemiaB-cell MalignanciesChronic Lymphocytic LeukemiaDLBCLDiffuse Large B-cell Lymphoma

Phase 1

Entospletinib Monotherapy and in Combination With Chemotherapy in Adults With Acute Myeloid Leukemia (AML)

TerminatedNCT02343939

Gilead SciencesAcute Myeloid Leukemia

Start: 2015-07-01End: 2019-02-21Updated: 2019-11-15

Safety and Efficacy of Entospletinib With Vincristine and Dexamethasone in Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL)

TerminatedNCT02404220

Gilead SciencesAcute Lymphoblastic Leukemia

Start: 2015-05-06End: 2018-12-17Updated: 2020-01-02

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

Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function

CompletedNCT02521376

Gilead SciencesOncology

Start: 2015-11-16End: 2017-10-25Updated: 2019-07-26

Safety and Efficacy of Entospletinib (ENTO [GS-9973]) Combined With Vincristine (VCR) in Adult Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (NHL)

TerminatedNCT02568683

Gilead SciencesNon-Hodgkin Lymphoma

Start: 2016-02-11End: 2017-06-22Updated: 2019-04-17

Entospletinib and Obinutuzumab in Treating Patients With Relapsed Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, or Non-Hodgkin Lymphoma

CompletedNCT03010358

Alexey Danilov, MDAnemia, B-Cell Prolymphocytic Leukemia, Grade 1 Follicular Lymphoma +11

Start: 2017-07-17End: 2021-04-29Updated: 2023-08-08

Entospletinib (ENTO) as Monotherapy and in Combination With Chemotherapy in Japanese Adults

TerminatedNCT03135028

Gilead SciencesAcute Myeloid Leukemia, Hematologic Malignancy

Start: 2017-05-19End: 2019-02-26Updated: 2020-03-06

Study of Entospletinib (ENTO) in Newly Diagnosed DLBCL Patients With aaIPI>=1 Treated by Chemiotherapy

TerminatedNCT03225924

The Lymphoma Academic Research OrganisationDLBCL

Start: 2017-07-26End: 2019-10-18Updated: 2020-09-02

Phase 2

Entospletinib in Combination With Idelalisib in Adults With Relapsed or Refractory Hematologic Malignancies

TerminatedNCT01796470

Gilead SciencesChronic Lymphocytic Leukemia, Diffuse Large B-cell Lymphoma, Indolent Non-Hodgkin's Lymphoma +1

Start: 2013-06-20End: 2016-12-22Updated: 2020-06-02

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

Phase 3

Entospletinib Plus Intensive Induction/Consolidation Chemotherapy in Newly Diagnosed NPM1-mutated AML

TerminatedNCT05020665

Kronos BioNucleophosmin 1-mutated Acute Myeloid Leukemia

Start: 2021-11-24End: 2023-03-30Updated: 2024-01-10

Related Papers

Responses in patients with AML and treated with entospletinib monotherapy.

Journal of Clinical Oncology2023-06-011 citations

Targeting Measurable Residual Disease (MRD) in Acute Myeloid Leukemia (AML): Moving beyond Prognostication.

2023-03-0120 citations

SYK Inhibitors, Entospletinib and Lanraplenib, Show Potent Anti-Leukemic Activity in Combination with Targeted Agents

Blood2022-11-152 citations

Development of a Standardized, DNA-Based Next Generation Sequencing Assay for Assessment of Measurable Residual Disease (MRD) in Acute Myeloid Leukemia (AML) As the Primary Endpoint in the Agility Study

Blood2022-11-15

P428: SYK INHIBITION DRIVES DEEP RESPONSES IN A BIOMARKER GUIDED SUBSET OF AML ALONE AND IN RATIONAL COMBINATIONS

HemaSphere2022-06-01

P392: PHARMACOLOGICAL INHIBITION OF SYK CONFERS ANTI-PROLIFERATIVE AND NOVEL ANTI-TUMOR IMMUNE RESPONSES IN AML

HemaSphere2022-06-01

Final Results of a Phase 1/2 Study of SYK Inhibitor Entospletinib in Combination with Obinutuzumab in Patients with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)

Blood2021-11-052 citations

Proapoptotic and immunomodulatory effects of SYK inhibitor entospletinib in combination with obinutuzumab in patients with chronic lymphocytic leukaemia

British Journal of Clinical Pharmacology2021-07-0111 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 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

Abstract 819: High response rates with entospletinib in patients with t(v;11q23.3);<i>KMT2A</i> rearranged acute myeloid leukemia and acute lymphoblastic leukemia

Cancer Research2018-07-012 citations

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

Interim Results of a Phase 1b/2 Study of Entospletinib (GS-9973) Monotherapy and in Combination with Chemotherapy in Patients with Acute Myeloid Leukemia

Blood2016-12-0215 citations

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