Evidence map›Paper›PMID 30555165›Full record

Trial reportLeukemia2019

Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome.

Jorge E Cortes, Florian H Heidel, Andrzej Hellmann, Walter Fiedler, B Douglas Smith, Tadeusz Robak, Pau Montesinos, Daniel A Pollyea, Pierre DesJardins, Oliver Ottmann and 7 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Leukemia, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 262 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
262citing papers in PubMed, 7 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01546038 phase2completednot on this map

A phase 1b/2 study to evaluate the safety and efficacy of pf-04449913, an oral hedgehog inhibitor, in combination with intensive chemotherapy, low dose ara-c or decitabine in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome

TypeinterventionalSponsorPfizerRan2012 to 2019Enrolled255ConditionsAcute Myeloid LeukemiaArmsPF-04449913, Low dose ARA-C (LDAC), Decitabine, Daunorubicin, Cytarabine
NCT03957915 early_phase1completednot on this mapstarted 2020, after this paper: background citation

A Phase I, First in Human, Open-label Study of Escalating Doses of INA03 Administered Intravenously as Single Agent in Adult Patients With Relapse/Refractory Acute Leukemia

TypeinterventionalSponsorInstitut Paoli-CalmettesRan2020 to 2025Enrolled33ConditionsAcute Lymphoblastic Leukemia Recurrent, Acute Lymphoblastic Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukaemia RecurrentArmsINA03 administration
3 · Its place in the literature

Who cites it

262 citing papers in PubMed, 7 syntheses or guidelines pooled it.

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  14. Glasdegib plus low-dose cytarabine for acute myeloid leukemia: Practical considerations from advanced practitioners and pharmacists.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2021
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  19. The logarithmic phase as a therapeutic direction: evaluating pharmacological strategies against cancer progression.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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202 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Jorge E CortesDepartment of Leukemia, University of Texas, MD Anderson Cancer Center, Houston, TX, USA. jcortes@mdanderson.org.
Florian H HeidelOtto-von-Guericke University Medical Center, Magdeburg, Germany.
Andrzej HellmannDepartment of Haematology and Transplantology, Medical University of Gdańsk, Gdańsk, Poland.
Walter FiedlerDepartment of Hematology and Oncology, University Hospital Hamburg-Eppendorf, Hamburg, Germany.
B Douglas SmithJohns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, MD, USA.
Tadeusz RobakDepartment of Hematology, Medical University of Lodz, Lodz, Poland.
Pau MontesinosHospital Universitari i Politècnic La Fe, Valencia, Spain.ORCID http://orcid.org/0000-0002-3275-5593
Daniel A PollyeaDivision of Hematology, University of Colorado School of Medicine, Aurora, CO, USA.ORCID http://orcid.org/0000-0001-6519-4860
Pierre DesJardinsHôpital Charles LeMoyne, Greenfield Park, QC, Canada.
Oliver OttmannDivision of Cancer and Genetics, School of Medicine, Cardiff University, Cardiff, UK.
Weidong Wendy MaPfizer Oncology, New York, NY, USA.
M Naveed ShaikPfizer Oncology, New York, NY, USA.
A Douglas LairdPfizer Oncology, New York, NY, USA.
Mirjana ZeremskiPfizer Oncology, New York, NY, USA.
Ashleigh O'ConnellPfizer Oncology, New York, NY, USA.
Geoffrey ChanPfizer Oncology, New York, NY, USA.
Michael HeuserDepartment of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Glasdegib is a Hedgehog pathway inhibitor. This phase II, randomized, open-label, multicenter study (ClinicalTrials.gov, NCT01546038) evaluated the efficacy of glasdegib plus low-dose cytarabine (LDAC) in patients with acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome unsuitable for intensive chemotherapy. Glasdegib 100 mg (oral, QD) was administered continuously in 28-day cycles; LDAC 20 mg (subcutaneous, BID) was administered for 10 per 28 days. Patients (stratified by cytogenetic risk) were randomized (2:1) to receive glasdegib/LDAC or LDAC. The primary endpoint was overall survival. Eighty-eight and 44 patients were randomized to glasdegib/LDAC and LDAC, respectively. Median (80% confidence interval [CI]) overall survival was 8.8 (6.9-9.9) months with glasdegib/LDAC and 4.9 (3.5-6.0) months with LDAC (hazard ratio, 0.51; 80% CI, 0.39-0.67, P = 0.0004). Fifteen (17.0%) and 1 (2.3%) patients in the glasdegib/LDAC and LDAC arms, respectively, achieved complete remission (P < 0.05). Nonhematologic grade 3/4 all-causality adverse events included pneumonia (16.7%) and fatigue (14.3%) with glasdegib/LDAC and pneumonia (14.6%) with LDAC. Clinical efficacy was evident across patients with diverse mutational profiles. Glasdegib plus LDAC has a favorable benefit-risk profile and may be a promising option for AML patients unsuitable for intensive chemotherapy.

Indexed as

AgedAged, 80 and overAntimetabolites, AntineoplasticBenzimidazolesCytarabineDrug Therapy, CombinationFemaleFollow-Up StudiesHumansLeukemia, Myeloid, AcuteMaleMiddle AgedMyelodysplastic SyndromesPhenylurea CompoundsPrognosisSurvival RateAntimetabolites, AntineoplasticBenzimidazolesCytarabineglasdegibPhenylurea Compounds

Identifiers

PMID30555165
PMCPMC6365492

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.