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Clinical trialNCT02920008CompletedPhase 3Interventional

Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemia

SponsorAstex Pharmaceuticals, Inc.Enrollment302Acute Myeloid Leukemia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Multicenter, randomized, open-label, parallel-group study of guadecitabine vs treatment choice (TC). Participants will be randomly assigned in a 1:1 ratio to either guadecitabine or TC. TC options include the 8 high or low intensity, locally available regimens below; or Best supportive Care (BSC) alone: * High intensity (intermediate or high dose cytarabine \[HiDAC\]; mitoxantrone, etoposide, and cytarabine \[MEC\]; or fludarabine, cytarabine, granulocyte colony stimulating factor \[G-CSF\], +/- idarubicin \[FLAG/FLAG-Ida\]). * Low intensity (low dose cytarabine \[LDAC\], decitabine, or azacitidine). * BSC.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

95 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Belgium
  • Az Sint-Jan Brugge-Oostende Av

    Bruges, Belgium

  • Cliniques Universitaires Saint-Luc

    Brussels, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

Canada
  • Tom Baker Cancer Centre

    Calgary, Alberta, Canada

  • University of Alberta Hospital

    Edmonton, Alberta, Canada

  • Princess Margaret Cancer Centre

    Toronto, Ontario, Canada

  • Mcgill University Health Centre

    Montreal, Quebec, Canada

  • Hopital Maisonneuve Rosemont

    Montreal, Canada

Denmark
  • Aarhus University Hospital

    Aarhus C, Denmark

  • Rigshospitalet

    Copenhagen, Denmark

France
  • Centre Hospitalier de la Côte Basque

    Bayonne, France

  • Hôpital de la Conception

    Marseille, France

  • Chru Montpellier - Saint Eloi

    Montpellier, France

  • Groupe Hospitalier de la Région de Mulhouse Et Sud Alsace

    Mulhouse, France

  • Hôpital Saint-Louis

    Paris, France

  • Chu Hopitaux de Bordeaux - Hôpital Haut-Lévêque

    Pessac, France

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, France

  • Centre Henri Becquerel

    Rouen, France

  • Institut Universitaire Du Cancer de Toulouse - Oncopole

    Toulouse, France

Germany
  • Universitätsklinikum Leipzig

    Leipzig, Saxony, Germany

  • Städtisches Klinikum Braunschweig Ggmbh

    Braunschweig, Germany

  • Marien Hospital Düsseldorf Gmbh

    Düsseldorf, Germany

  • Universitätsklinikum Halle (saale)

    Halle, Germany

  • Universitätsklinikum Schleswig-Holstein

    Kiel, Germany

  • Medizinischen Fakultät Mannheim Der Universität Heidelberg

    Mannheim, Germany

  • Klinikum Der Universität München

    München, Germany

  • Universitätsklinikum Ulm

    Ulm, Germany

Hungary
  • Se Áok I. Sz. Belgyógyászati Klinika

    Budapest, Hungary

  • Debreceni Egyetem Klinikai Központ

    Debrecen, Hungary

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, Hungary

  • Pecsi Tudomanyegyetem Klinikai Központ

    Pécs, Hungary

  • Szegedi Tudományegyetem

    Szeged, Hungary

Italy
  • Irccs Aou San Martino - Ist

    Genova, Italy

  • Fondazione Irccs Cà Granda Ospedale Maggiore Policlinico

    Milan, Italy

  • Ospedale San Raffaele - Milano

    Milan, Italy

  • A.O.R.N. "a. Cardarelli"

    Naples, Italy

  • A.S.U Integrata Di Udine - Presidio Ospedaliero Santa Maria Della Misericordia

    Udine, Italy

Japan
  • Akita University Hospital

    Akita, Japan

  • Chugoku Central Hospital

    Fukuyama-Shi, Japan

  • Tokai University Hospital

    Isehara-shi, Japan

55 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Treatment ChoiceGuadecitabine
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
16 Mar 2017
Primary completion
20 Jan 2020
Completion
1 Jun 2020
Last update posted
28 Aug 2024
Registered enrollment
302
Registry id
NCT02920008
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.