Study of Elacytarabine Versus Investigator's Choice in Patients With Late Stage Acute Myeloid Leukaemia (AML)
NCT ID: NCT01147939
Last Updated: 2013-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
381 participants
INTERVENTIONAL
2010-06-30
2013-06-30
Brief Summary
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Detailed Description
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Elacytarabine is an investigational drug which is not commercially available. It is the elaidic acid ester derivative of cytarabine. Cytarabine is routinely used in the treatment of patients with AML. A substantial portion of AML patients have a deficient uptake of cytarabine, often explained by lack of a transport protein (hENT1) in the leukemic cell membrane. Due to the elaidic acid (a naturally occurring fatty acid), cellular uptake of elacytarabine is independent of this transport protein.
Patients included in the study will be randomized to elacytarabine or control treatment. Since there is no standard therapy for relapsed or refractory AML, there is a list of 7 control treatments and the investigator has to choose one that is locked before randomization.
Elacytarabine is given as a continuous infusion over five days, followed by a rest period of minimum two weeks. Investigator's choice treatment is given according to the specific routine.
After each course response evaluation and a decision on further treatment will be made.
Repeated courses of elacytarabine and control treatment might be needed to attain and/or maintain complete remission or clinical benefit.
After the end of study treatment, all patients will be followed for relapse and survival.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Elacytarabine
Elacytarabine
Elacytarabine 2000 mg/m2/d administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w cycle.
Investigator's Choice
Investigator's Choice
E.g. cytarabine single agent/combinations, hypomethylating agents, best supportive care (BSC)
Interventions
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Elacytarabine
Elacytarabine 2000 mg/m2/d administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w cycle.
Investigator's Choice
E.g. cytarabine single agent/combinations, hypomethylating agents, best supportive care (BSC)
Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of AML according to WHO classification (excluding acute promyelocytic leukaemia) who have received two or three previous induction/re-induction regimens or patients of age ≥ 65 with adverse cytogenetics who have received 1-3 previous induction/re-induction regimens. One of the (re-)induction regimens could be stem cell transplantation (SCT) for achievement of remission. Maintenance and consolidation (including SCT) may have been given, but are not counted as previous regimens.
* Bone marrow aspirates and/or biopsies must contain \> 5 % leukaemic blast cells or patient must have biopsy-proven extramedullary AML, or patient's peripheral blood shows occurrence of leukaemic blast cells
* Patients must
* have never attained CR or CRi (primary refractory), or
* have failed initial induction therapy, and have attained CR or CRi after salvage therapy(ies), and then relapsed within \< 6 months, or
* have attained CR or CRi after initial induction therapy and relapsed within \<12 months, and failed to respond to salvage therapy(ies), or
* have relapsed after the latest CR or CRi within \< 6 months
* Patients younger than 65 years should have received previous treatment with cytarabine
* Patients must have recovered from previous bone marrow and/or stem cell transplantation to a stage that the patient can tolerate the study treatment. There is no restriction on number of regimens or type of treatment administered for maintenance or consolidation during previous stages of the disease
* ECOG performance status (PS) of 0 - 2
* Women of child-bearing potential must have a negative serum or urine pregnancy test within 2 weeks prior to treatment start
* Male and female patients must use acceptable contraceptive methods for the duration of time on study, and males also for 3 months after the last elacytarabine dose
* Capable of understanding and complying with protocol requirements, and must be able and willing to sign a written informed consent form
Exclusion Criteria
* Persistent clinically significant toxicities from previous chemotherapy
* A cancer history that, according to the investigator, might confound the assessment of the study endpoints
* Known positive status for human immunodeficiency virus (HIV)
* Pregnant and nursing patients
* Uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, or psychiatric illness/social situations that would limit compliance with study requirements
* Impairment of hepatic or renal function to such an extent that the patient, in the opinion of the investigator, will be exposed to an excessive risk if entered into this clinical study
* Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure. Any New York Heart Association (NYHA) functional classification grade 3 or 4
* Applicable only for patients for whom an anthracycline is part of the selected control treatment: Left ventricular ejection fraction (LVEF) must be ≥ 45 % as measured by MUGA scan or 2D ECHO within 14 days prior to start of therapy. Either method is acceptable for measuring LVEF
* Applicable only for patients for whom an anthracycline is part of the selected control treatment: The patient should tolerate minimum one course of combination therapy
* Any anti-leukaemic agents within the last 3 weeks. Hydroxyurea,however, is allowed for up to 12 hours prior to study treatment
* Any investigational treatment within the last 14 days
* Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
18 Years
ALL
No
Sponsors
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Clavis Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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David Rizzieri, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University Medical Center, Durham, NC, USA
Francis J Giles, MD, PhD
Role: STUDY_CHAIR
Cancer Therapy & Reseach Center at the University of Texas Health Science Center San Antonio, TX, USA
Locations
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Scripps Cancer Center Clinical Research
La Jolla, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
UCLA School of Medicine, Division of Hematology/Oncology
Los Angeles, California, United States
Rocky Mountain Blood and Bone Marrow Transplant Program
Denver, Colorado, United States
Shands at the University of Florida
Gainesville, Florida, United States
Winship Cancer Institute at Emory
Atlanta, Georgia, United States
The Blood and Marrow Transplant Group of GA
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
St. Francis Hospital and Health Center
Indianapolis, Indiana, United States
University of Iowa Hopsitals
Iowa City, Iowa, United States
LSU Health Sciences Center,
Shreveport, Louisiana, United States
Northern New Jersey Cancer Associates
Hackensack, New Jersey, United States
New York Presbyterian Hospital, Weill-Cornell Medical College
New York, New York, United States
Memorial Sloan-Kettering
New York, New York, United States
New York Medical College
Valhalla, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Wake Forest University, Health Sciences Section on Hematology and Oncology
Winston-Salem, North Carolina, United States
The Jewish Hospital
Cincinnati, Ohio, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
St. Francis Hospital
Greenville, South Carolina, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Froedtert Hospital, Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal North Shore Hopsital
Sydney, New South Wales, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Box Hill Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Algemeen Ziekenhuis Sint-Jan
Bruges, , Belgium
Institut Jules Bordet
Brussels, , Belgium
UZ Brussel
Brussels, , Belgium
University Hospital Antwerp
Edegem, , Belgium
CHU Liège
Liège, , Belgium
UCL Mont-Godinne
Yvoir, , Belgium
Princess Margaret Hospital
Toronto, Ontario, Canada
CHU Limoges - Hôpital Dupuytren
Limoges, , France
Hopital Edouard Herriot
Lyon, , France
Institut J. Paoli and I. Calmettes
Marseille, , France
Centre Antoine Lacassagne
Nice, , France
Hopital Saint Antoine
Paris, , France
CHU de Bordeaux - Hopital Haut-Leveque
Pessac, , France
CHU de Toulouse - Hôpital Purpan
Toulouse, , France
Charité-Campus B. Franklin Med. Klinik Haematology
Berlin, , Germany
Evangelische Kliniken Johanniter- und Waldkrankenhaus Bonn GmbH
Bonn, , Germany
Heinrich-Heine Universität Düsseldorf, Klinik für Hämatologie/Onkolog. und Klin. Immunologie
Düsseldorf, , Germany
III. Medizinische Klinik und Poliklinik;Hämatologie, Onkologie und Pneumologie
Mainz, , Germany
Universitätsklinikum Münster, Medisinische Klinik & Poliklinik A
Münster, , Germany
Universitätsklinikum Rostock
Rostock, , Germany
Robert-Bosch-Krankenhaus, Abt.Hämatologie,Onkologie u.Palliativmedizin
Stuttgart, , Germany
Universitätsklinikum Ulm, Klinik für Innere Medizin III, Comprehensive Cancer Center Ulm (CCCU)
Ulm, , Germany
St James's Hospital Dublin
Dublin, , Ireland
University Hospital Galway
Galway, , Ireland
A.O.U Careggi
Florence, , Italy
A.O San Martino
Genova, , Italy
Fondazione San Raffaele del Monte Tabor
Milan, , Italy
A.O. Cardarelli
Napoli, , Italy
Hospital S. Maria delle Croci
Ravenna, , Italy
Fondazion Policlin T Vergata
Roma, , Italy
Haukeland Universitetssykehus
Bergen, , Norway
Oslo University Hospital
Oslo, , Norway
St Olavs Hospital
Trondheim, , Norway
Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
Wroclaw, , Poland
Fundeni Clinical Institute "Stefan Berceanu" Center for Hematology and Bone Marrow Transplant
Bucharest, , Romania
Oncology Institute ,,Ion Chiricuta" Cluj Napoca , Hematology dept.
Cluj-Napoca, , Romania
St. Spiridon" University Hospital, Hematology Department
Iași, , Romania
Hospital de Navarra
Pamplona, Spain, Spain
Hospital Germans Trias i Pujol
Badalona, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitari Son Dureta
Palma de Mallorca, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Universitario La Fé, Servicio de Hematología
Valencia, , Spain
Gartnavel General Hospital: Beatson WOS Cancer Centre
Glasgow, Scotland, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Christie Hospital, Haematology and Transplant Day Unit
Manchester, , United Kingdom
Countries
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References
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Roboz GJ, Rosenblat T, Arellano M, Gobbi M, Altman JK, Montesinos P, O'Connell C, Solomon SR, Pigneux A, Vey N, Hills R, Jacobsen TF, Gianella-Borradori A, Foss O, Vetrhusand S, Giles FJ. International randomized phase III study of elacytarabine versus investigator choice in patients with relapsed/refractory acute myeloid leukemia. J Clin Oncol. 2014 Jun 20;32(18):1919-26. doi: 10.1200/JCO.2013.52.8562. Epub 2014 May 19.
Related Links
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Related Info
Other Identifiers
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CP4055-306
Identifier Type: -
Identifier Source: org_study_id