Evidence map›Paper›PMID 29720733›Full record

Trial reportLeukemia2018

Adding dasatinib to intensive treatment in core-binding factor acute myeloid leukemia-results of the AMLSG 11-08 trial.

Peter Paschka, Richard F Schlenk, Daniela Weber, Axel Benner, Lars Bullinger, Michael Heuser, Verena I Gaidzik, Felicitas Thol, Mridul Agrawal, Veronica Teleanu and 24 more

3 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 70 papers.

0numbers the graph read from it
0cells of the map it votes in
70citing papers in PubMed
8.8field-weighted citation impact, top 2% of its field
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.

NCT00850382 phase1 / phase2completednot on this map

Open-Label, Multicenter Phase Ib/IIa Study For the Evaluation of Dasatinib (Sprycel™) Following Induction and Consolida-tion Therapy as Well as in Maintenance Therapy in Patients With Newly Diagnosed Core Binding Factor (CBF) Acute Myeloid Leukemia (AML)

TypeinterventionalSponsorUniversity of UlmRan2009 to 2015Enrolled89ConditionsAcute Myeloid Leukemia (AML)ArmsDasatinib, daunorubicin, Cytarabine
NCT02013648 phase3completednot on this map

Randomized Phase III Study of Intensive Chemotherapy With or Without Dasatinib (Sprycel™) in Adult Patients With Newly Diagnosed Core-Binding Factor Acute Myeloid Leukemia (CBF-AML)

TypeinterventionalSponsorUniversity of UlmRan2014 to 2024Enrolled204ConditionsAcute Myeloid Leukemia (AML)ArmsDasatinib, Cytarabine, Daunorubicin, Idarubicin
NCT05404516 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

Prospective Evaluation of Sorafenib Combined With Standard Therapy in Newly Diagnosed Adult Core-binding Factor Acute Myeloid Leukemia: an Open-label , Randomised Controlled, Multicenter Phase II Trial

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2020 to 2023Enrolled88ConditionsCore Binding Factor Acute Myeloid LeukemiaArmsSorafenib, Idarubicin, Cytarabine
3 · Its place in the literature

Who cites it

70 citing papers in PubMed, 106 citations in OpenAlex.

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  11. Mutation- and MRD-informed treatment decisions for the transplant-eligible AML patient.Hematology. American Society of Hematology. Education Program · 2024
    Review
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  20. Improving long-term outcomes with intensive induction chemotherapy for patients with AML.Hematology. American Society of Hematology. Education Program · 2023
    Article

10 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

34 authors at 20 institutions in 2 countries.

Peter PaschkaKlinik für Innere Medizin III, Universitätsklinikum Ulm, Ulm, Germany. peter.paschka@uniklinik-ulm.de.
Richard F SchlenkKlinik für Innere Medizin III, Universitätsklinikum Ulm, Ulm, Germany.
Daniela WeberKlinik für Innere Medizin III, Universitätsklinikum Ulm, Ulm, Germany.
Axel BennerAbteilung Biostatistik, Deutsches Krebsforschungszentrum, Heidelberg, Germany.
Lars BullingerKlinik für Innere Medizin III, Universitätsklinikum Ulm, Ulm, Germany.
Michael HeuserKlinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover, Hannover, Germany.
Verena I GaidzikKlinik für Innere Medizin III, Universitätsklinikum Ulm, Ulm, Germany.
Felicitas TholKlinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover, Hannover, Germany.
Mridul AgrawalKlinik für Innere Medizin III, Universitätsklinikum Ulm, Ulm, Germany.
Veronica TeleanuKlinik für Innere Medizin III, Universitätsklinikum Ulm, Ulm, Germany.
Michael LübbertKlinik für Innere Medizin I, Medizinische Fakultät, Universitätsklinikum Freiburg, Freiburg, Germany.
Walter FiedlerII. Medizinische Klinik und Poliklinik, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
Markus RadsakIII. Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz, Mainz, Germany.ORCID http://orcid.org/0000-0002-3991-5721
Jürgen KrauterMedizinische Klinik III, Klinikum Braunschweig, Braunschweig, Germany.
Heinz-A HorstKlinik für Innere Medizin II, Universitätsklinikum Schleswig-Holstein, Kiel, Germany.
Richard Greil3. III. Medizinische Universitätsklinik, Paracelsus Medizinische Privatuniversität Salzburg, Salzburg Cancer Research Institute, Cancer Cluster Salzburg, Salzburg, Austria.
Karin MayerMedizinische Klinik und Poliklinik III, Universitätsklinikum Bonn, Bonn, Germany.
Andrea KündgenKlinik für Hämatologie, Onkologie und Klinische Immunologie, Universitätsklinikum Düsseldorf, Düsseldorf, Germany.
Uwe MartensKlinik für Innere Medizin III, SLK-Kliniken Heilbronn GmbH, Heilbronn, Germany.
Gerhard HeilInnere Medizin V, Märkische Kliniken, Klinikum Lüdenscheid, Lüdenscheid, Germany.
Helmut R SalihInnere Medizin II, Medizinische Klinik, Universitätsklinikum Tübingen, Tübingen, Germany.
Bernd HertensteinMedizinische Klinik I, Klinikum Bremen-Mitte, Bremen, Germany.
Carsten SchwänenKlinik für Allgemeine Innere Medizin, Onkologie/Hämatologie, Gastroenterologie und Infektiologie, Klinikum Esslingen GmbH, Esslingen, Germany.
Gerald WulfKlinik für Hämatologie und Medizinische Onkologie, Universitätsmedizin Göttingen, Göttingen, Germany.
Elisabeth LangeKlinik für Hämatologie, Onkologie und Palliativmedizin, Evangelisches Krankenhaus Hamm, Hamm, Germany.
Michael PfreundschuhInnere Medizin I, Universitätsklinikum des Saarlandes, Homburg, Germany.ORCID http://orcid.org/0000-0001-6982-8218
Mark RinghofferMedizinische Klinik III, Städtisches Klinikum Karlsruhe gGmbH, Karlsruhe, Germany.
Michael GirschikofskyInterne 1-Hämato-Onkologie, Krankenhaus der Elisabethinen Linz, Linz, Austria.
Thomas HeinickeKlinik für Hämatologie und Onkologie, Universitätsklinikum Magdeburg, Magdeburg, Germany.
Doris KraemerKlinik für Onkologie und Hämatologie, Klinikum Oldenburg, Oldenburg, Germany.
Gudrun GöhringInstitut für Humangenetik, Medizinische Hochschule Hannover, Hannover, Germany.
Arnold GanserKlinik für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Medizinische Hochschule Hannover, Hannover, Germany.
Konstanze DöhnerKlinik für Innere Medizin III, Universitätsklinikum Ulm, Ulm, Germany.
Hartmut DöhnerKlinik für Innere Medizin III, Universitätsklinikum Ulm, Ulm, Germany.
University Hospital Ulm · DEMedizinische Hochschule Hannover · DEDüsseldorf University Hospital · DEEvangelisches Krankenhaus Hamm · DEGerman Cancer Research Center · DEJohannes Gutenberg University Mainz · DEKlinikum Braunschweig · DEKlinikum Bremen-Mitte · DEKlinikum Esslingen · DEKlinikum Lüdenscheid · DEKlinikum Magdeburg · DEKlinikum Oldenburg · DEKrankenhaus der Elisabethinen · ATParacelsus Medical University · ATSLK-Kliniken Heilbronn · DEStädtisches Klinikum Karlsruhe · DEUniversität Hamburg · DEUniversitätsklinikum des Saarlandes · DEUniversitätsklinikum Tübingen · DEUniversitätsmedizin Göttingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In this phase Ib/IIa study (ClinicalTrials.gov Identifier: NCT00850382) of the German-Austrian AML Study Group (AMLSG) the multikinase inhibitor dasatinib was added to intensive induction and consolidation chemotherapy and administered as single agent for 1-year maintenance in first-line treatment of adult patients with core-binding factor (CBF) acute myeloid leukemia (AML). The primary combined end point in this study was safety and feasibility, and included the rates of early (ED) and hypoplastic (HD) deaths, pleural/pericardial effusion 3°/4° and liver toxicity 3°/4°, and the rate of refractory disease. Secondary end points were cumulative incidence of relapse (CIR) and death in complete remission (CID), and overall survival (OS). Eighty-nine pts [median age 49.5 years, range: 19-73 years; t(8;21), n = 37; inv (16), n = 52] were included. No unexpected excess in toxicity was observed. The rates of ED/HD and CR/CRi were 4.5% (4/89) and 94% (84/89), respectively. The 4-year estimated CIR, CID, and OS were 33.1% [95%-CI (confidence interval), 22.7-43.4%], 6.0% (95% CI, 0.9-11.2%), and 74.7% (95% CI, 66.1-84.5%), respectively. On the basis of the acceptable toxicity profile and favorable outcome in the AMLSG 11-08 trial, a confirmatory randomized phase III trial with dasatinib in adults with CBF-AML is ongoing (ClinicalTrials.gov Identifier: NCT02013648).

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCore Binding FactorsDasatinibFemaleHumansLeukemia, Myeloid, AcuteMaleMiddle AgedMutationProto-Oncogene Proteins c-kitRecurrenceRemission InductionTreatment OutcomeBiomarkers, TumorCore Binding FactorsDasatinibProto-Oncogene Proteins c-kit

Identifiers

PMID29720733
OpenAlexW2802281739

What OpenQuestion holds

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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.