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Clinical trialNCT03504410TerminatedPhase 3Interventional

Efficacy/Safety of CPI-613 in Combination With HD Cyt. and Mito. vs HD Cyt. and Mito. in Older Patients With R/R AML

SponsorCornerstone PharmaceuticalsEnrollment200Relapsed/Refractory Acute Myeloid Leukemia
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in older patients with relapsed/refractory Acute Myeloid Leukemia. CPI-613® (devimistat) targets the altered energy metabolism and processes for production of ATP and essential bio-intermediates unique to and characteristic of most cancer cell types. The addition of CPI-613® (devimistat) to high dose cytarabine and mitoxantrone (CHAM) will improve the complete remission (CR) rate in patients 50 years or older with relapsed or refractory AML when compared to HAM alone or other control sub groups.
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

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

Australia
  • Border Medical Oncology Research Unit

    Albury, New South Wales, Australia

  • Gosford Hospital

    Gosford, New South Wales, Australia

  • Calvary Mater Newcastle Hospital

    Waratah, New South Wales, Australia

  • Royal Perth Hospital

    Perth, Western Australia, Australia

Austria
  • Universitätsklinik Für Innere Medizin

    Graz, Austria

  • Paracelsus Medical University

    Salzburg, Austria

  • Hanuschkrankenhaus Der Wgkk

    Vienna, Austria

Belgium
  • Algemeen Ziekenhuis Sint-Jan

    Bruges, Belgium

  • Clinique Universitaire St Luc

    Brussels, Belgium

  • Un Gent

    Ghent, Belgium

France
  • Centre Hospitalier de Versailles - Hôpital André Mignot

    Le Chesnay, Yvelines, France

  • Chu Amiens

    Amiens, France

  • Service D'Hématologie Clinique, Hôpital Avicenne-Aphp-Université Paris

    Bobigny, France

  • Chu de Caen

    Caen, France

  • Centre Hospitalier Universitaire Grenoble Hopital Michalon

    Grenoble, France

  • Chu la Conecption

    Marseille, France

  • Chu de Nice

    Nice, France

  • Hopital Saint Louis

    Paris, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, France

Germany
  • Klinikum Frankfurt Hoechst

    Frankfurt, Germany

  • Universitatsklinikumuksh Kiel

    Kiel, Germany

  • Universitatsklinikum Marburg

    Marburg, Germany

  • Robert-Bosch- Krankenhaus

    Stuttgart, Germany

Poland
  • Zespół Szpitali Miejskich W Chorzowie

    Chorzów, Poland

  • Uniwersyteckie Centrum Kliniczne Klinika Hematologii I Transplantologii

    Gdansk, Poland

  • Katedra I Klinika Hematologii

    Wroclaw, Poland

South Korea
  • Asan Medical Center

    Seoul, South Korea

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital

    Seoul, South Korea

Spain
  • Institut Catala D'Oncologia (ico) - Hospital Universitari Germans Trias I Pujol

    Badalona, Spain

  • Hospital Vall D'Hebron

    Barcelona, Spain

  • Md Anderson Cancer Center

    Madrid, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Spain

  • Hospital Son Espases

    Palma de Mallorca, Spain

  • Hospital Clínico Universitario de Salamanca

    Salamanca, Spain

  • Hospital U. P. la Fe

    Valencia, Spain

United States
  • Honor Health Research Institute

    Scottsdale, Arizona, United States

  • Chao Family Comprehensive Cancer Center (university of California Irvine)

    Orange, California, United States

  • California Pacific Medical Center

    San Francisco, California, United States

20 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.

CPI-613 + High Dose Cytarabine and MitoxantroneFludarabine →High Dose Cytarabine and MitoxantroneMitoxantrone →
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
12 Nov 2018
Primary completion
25 Oct 2021
Completion
19 Jan 2022
Last update posted
8 Feb 2023
Registered enrollment
200
Registry id
NCT03504410
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.