Glasdegib

DRUG14 trials

Sponsors

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., Pfizer, University of Nebraska, M.D. Anderson Cancer Center, Grupo Espanol de trasplantes hematopoyeticos y terapia celular

Conditions

ACUTE MYELOID LEUKEMIAAcute Myelogenous Leukemia (AML) Due to TherapyAcute Myeloid LeukemiaAcute Myeloid Leukemia With Myelodysplasia-Related ChangesAcute myeloid leukemiaAdult Acute Myeloid LeukemiaChronic Graft Versus Host DiseaseChronic Myelomonocytic Leukemia

Phase 1

Understanding The Effect Of A Strong CYP3A4 Inducer On Glasdegib Pharmacokinetics

CompletedNCT02430545

PfizerHealthy Volunteers

Start: 2015-05-31End: 2015-06-30Updated: 2015-06-25

A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation

CompletedNCT03130556

PfizerHealthy Volunteers

Start: 2017-05-01End: 2017-07-21Updated: 2017-08-01

OX40, Venetoclax, Avelumab, Glasdegib, Gemtuzumab Ozogamicin, and Azacitidine in Relapsed or Refractory Acute Myeloid Leukemia

CompletedNCT03390296

M.D. Anderson Cancer CenterRecurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia

Start: 2017-12-27End: 2022-02-04Updated: 2023-09-05

Glasdegib in Refractory Patients With Sclerotic Chronic Graft-Versus-Host Disease

Grupo Espanol de trasplantes hematopoyeticos y terapia celularSclerodermoid Chronic Graft-Versus-Host Disease (Disorder)

Start: 2018-01-09End: 2022-06-09Updated: 2022-03-17

Glasdegib for Chronic Graft-Versus-Host Disease

TerminatedNCT04111497

Fred Hutchinson Cancer CenterChronic Graft Versus Host Disease, Fasciitis

Start: 2019-12-03End: 2023-08-23Updated: 2024-10-29

Phase 2

Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia

CompletedNCT03226418

University of NebraskaAdult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Therapy-Related Acute Myeloid Leukemia

Start: 2017-07-07End: 2024-10-01Updated: 2026-03-10

GLAD-AML - Glasdegib (Pf-04449913) With Two Standard Decitabine Regimens for Older Patients With Poor-risk Acute Myeloid Leukemia

TerminatedNCT04051996

Yale UniversityACUTE MYELOID LEUKEMIA

Start: 2019-12-06End: 2020-06-09Updated: 2021-10-15

CPX-351 and Glasdegib for Newly Diagnosed Acute Myelogenous Leukemia With MDS Related Changes or Therapy-related Acute Myeloid Leukemia

Active, not recruitingNCT04231851

University of California, IrvineAcute Myelogenous Leukemia (AML) Due to Therapy, Acute Myeloid Leukemia With Myelodysplasia-Related Changes

Start: 2020-02-19End: 2027-06-30Updated: 2026-03-06

Phase 3

A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia

CompletedNCT03416179

PfizerLeukemia, Myeloid, Acute

Start: 2018-04-20End: 2022-01-17Updated: 2023-04-21

Molecular Profiling of Advanced Soft-tissue Sarcomas

Active, not recruitingNCT03784014

Institut National de la Santé Et de la Recherche Médicale, FranceSoft Tissue Sarcoma

Start: 2019-10-19End: 2026-01-13Updated: 2025-12-11

Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)

TerminatedNCT04093505

University Hospital HeidelbergAcute Myeloid Leukemia

Start: 2021-04-01End: 2022-06-23Updated: 2022-07-01

Continuation Study of B1371019(NCT03416179) and B1371012(NCT02367456) Evaluating Azacitidine With Or Without Glasdegib In Patients With Previously Untreated AML, MDS or CMML

CompletedNCT04842604

PfizerAcute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome

Start: 2021-05-17End: 2022-12-02Updated: 2023-12-18

IMPACT-AML: A RANDOMIZED PRAGMATIC CLINICAL TRIAL FOR RELAPSE OR REFRACTORY ACUTE MYELOID LEUKEMIA

RecruitingCTIS2024-514517-35-00

Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.Acute myeloid leukemia

Start: 2025-02-27Target: 267Updated: 2025-12-18

Unknown Phase

Acute Myeloid Leukemia Real World Treatment Patterns

WithdrawnNCT04230564

PfizerLeukemia, Myeloid, Acute

Start: 2020-10-31End: 2021-03-31Updated: 2023-06-07

Related Papers

Daunorubicin and cytarabine liposomal (CPX-351) plus glasdegib for newly diagnosed secondary Acute Myeloid Leukemia: Results of University of California hematologic malignancies consortium trial 1913

Blood2025-11-03

Prognostic impact of cognitive and other impairments in older adults with acute myeloid leukemia (AML) participating in a geriatric assessment-guided treatment selection trial

Blood2025-11-03

A Phase <scp>II</scp> Trial of Geriatric Assessment‐Guided Selection of Treatment Intensity in Older Adults With <scp>AML</scp>

American Journal of Hematology2025-04-293 citations

Longitudinal changes in cognitive and physical function and health-related quality of life in older adults with acute myeloid leukemia.

2023-11-248 citations

Use of Geriatric Assessment and Genetic Profiling to Personalize Selection of Intensive Versus Low Intensity Chemotherapy in Older Adults with Acute Myeloid Leukemia (AML): Final Results of a Phase II Trial

Blood2023-11-023 citations

Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial.

2023-08-2116 citations

Targeting Hedgehog Signaling with Glasdegib in Patients with Refractory Sclerotic Chronic GVHD: A Report of Two Phase I/II Trials

Clinical Cancer Research2023-08-014 citations

Targeting Hedgehog Signaling with Glasdegib in Patients with Refractory Sclerotic Chronic Graft vs. Host Disease: A Report of Two Phase I/II Trials

Blood2022-11-15

Older Adults with Acute Myeloid Leukemia (AML) Treated in a Pragmatic Trial: How Do Patients’ Function and Health-Related Quality of Life Change with Treatment?

Blood2022-11-15

A multi-arm phase Ib/II study designed for rapid, parallel evaluation of novel immunotherapy combinations in relapsed/refractory acute myeloid leukemia

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Integrating geriatric assessment and genetic profiling to personalize therapy selection in older adults with acute myeloid leukemia.

2022-04-1819 citations

Molecular profiling of advanced soft-tissue sarcomas: the MULTISARC randomized trial.

2021-11-0512 citations

Rationale and design of the 2 by 2 factorial design GnG-trial: a randomized phase-III study to compare two schedules of gemtuzumab ozogamicin as adjunct to intensive induction therapy and to compare double-blinded intensive postremission therapy with or without glasdegib in older patients with newly diagnosed AML.

2021-11-036 citations

Effect of geriatric assessment (GA) and genetic profiling on overall survival (OS) of older adults with acute myeloid leukemia (AML).

Journal of Clinical Oncology2021-05-201 citations

Prospective high-throughput genome profiling of advanced cancers: results of the PERMED-01 clinical trial

Genome Medicine2021-05-1853 citations

Clinical benefit of glasdegib plus low-dose cytarabine in patients with de novo and secondary acute myeloid leukemia: long-term analysis of a phase II randomized trial

Annals of Hematology2021-03-1952 citations

An evaluation of overall survival in patients with newly diagnosed acute myeloid leukemia and the relationship with glasdegib treatment and exposure.

2020-09-036 citations

Survival outcomes and clinical benefit in patients with acute myeloid leukemia treated with glasdegib and low-dose cytarabine according to response to therapy.

2020-07-1427 citations

A Phase 1b Study of Glasdegib in Combination with Azacitidine in Patients with Untreated Higher-Risk Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia

Blood2019-11-1316 citations

Clinical Benefit of Glasdegib in Combination with Azacitidine or Low-Dose Cytarabine in Patients with Acute Myeloid Leukemia

Blood2019-11-1312 citations

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