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Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study

Primary Purpose

Secondary Acute Myeloid Leukemia (Secondary AML, sAML)

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Daunorubicin and Cytarabine
Amonafide and Cytarabine
Sponsored by
Antisoma Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Secondary Acute Myeloid Leukemia (Secondary AML, sAML) focused on measuring AML, Leukemia, MDS, Amonafide, Cytarabine, Daunorubicin, Lymphatic disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of AML according to WHO diagnostic criteria (at least 20% blasts in the peripheral blood or bone marrow), with FAB classification other than M3 (Acute Promyelocytic Leukemia), documented by bone marrow aspiration and biopsy performed within 14 days prior to administration of 1st dose of remission induction chemotherapy;
  • Either: Known and documented exposure to specific leukemogenic therapy of a specified nature for a non-myeloid condition; OR Documented diagnosis of MDS according to WHO criteria for at least 3 months prior to study entry, with prior bone marrow aspirate, biopsy and peripheral blood smear documenting MDS available to be submitted for subsequent central pathology review.
  • Age 18 years or older;
  • Eastern Cooperative Oncology Group (ECOG) performance score =< 2;
  • Fertile sexually active patients (men and women) must use an effective method of contraception which must be continued throughout the study.
  • Women of childbearing potential must have a negative serum pregnancy test.
  • Left Ventricular Ejection Fraction (LVEF) >= 50%, as determined by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO) within 14 days prior to administration of 1st dose of remission induction chemotherapy;
  • Adequate renal function as evidenced by the following laboratory test, obtained within 10 days prior to administration of 1st dose of remission induction chemotherapy: Serum creatinine =< 1.5 x ULN;
  • Adequate hepatic function as evidenced by the following laboratory tests, obtained within 10 days prior to administration of 1st dose of remission induction chemotherapy (unless attributed to hepatic involvement with AML): Total serum bilirubin =< 1.5 x ULN;Serum AST and ALT =< 1.5 x ULN;
  • Ability of the patient to participate fully in all aspects of this clinical trial;
  • Written Informed Consent and HIPAA authorization (USA sites only) must be obtained and documented.

Exclusion Criteria:

  • Histologic diagnosis of FAB M3 Acute Promyelocytic Leukemia;
  • Clinically active CNS leukemia;
  • Prior induction therapy for AML;
  • Known HIV positive;
  • Known active hepatitis B or C, or any other active liver disease;
  • Patients with parenchymal abnormality on screening chest x-ray must have no evidence of pulmonary infection on chest tomography (CT) prior to starting remission induction therapy.
  • Any major surgery or radiation therapy within 4 weeks prior to study entry;
  • Prior cytotoxic chemotherapy for MDS within 4 weeks prior to study entry (patients with rapidly rising blast count may be enrolled within 4 weeks of prior cytotoxic chemotherapy with waiver from the Medical Monitor);
  • Persistent chronic non-hematologic toxicity (other than alopecia) greater than grade 1 from prior therapy for MDS;
  • Serious concomitant illnesses (for example, pulmonary infiltrate, unstable angina or myocardial infarction or stroke within 3 months prior to study entry, congestive heart failure AHA class 2 or greater, uncontrolled hypertension, uncontrolled diabetes, actively bleeding gastric ulcer, etc.), which in the investigator's opinion would not make the patient a good candidate for the trial;
  • Pregnant or breast feeding;
  • History of clinically significant allergic reactions attributed to compounds of similar chemical or biological composition to amonafide, cytarabine or daunorubicin;
  • Prior enrollment in this trial;
  • Any other known condition (e.g., familial, sociological, or geographical) or behavior (including substance dependence or abuse, psychological or psychiatric illness), which in the investigator's opinion would make the patient a poor candidate for the trial.

Sites / Locations

  • UCLA Medical Center
  • Univ of Southern California Comprehensive Cancer Center
  • University of California San Francisco
  • University of Colorado Health Sciences Center
  • Rocky Mountain Blood and Marrow Transplant Program
  • Winship Cancer Institute, Emory University
  • The Blood and Marrow Transplant Group of GA
  • Northwestern University School of Medicine
  • Rush University Medical Center
  • University of Iowa Hospitals
  • James Graham Brown Cancer Center
  • LSU Health Sciences Center, Feist-Weiller Cancer Center
  • Dana Farber Cancer Institute
  • Massachusetts General Hospital
  • University of Michigan Cancer Center
  • Michigan State University
  • Roswell Park Cancer Institute
  • Northshore Hospital - Monter Cancer Center
  • Duke University Medical Center
  • Wake Forest University Health Sciences
  • Taussig Cancer Center, Cleveland Clinic
  • Oregon Health & Science University
  • Penn State Hershey Medical Center
  • Thomas Jefferson University
  • Western Pennsylvania Hospital
  • Roger Williams Medical Center
  • Medical University of South Carolina
  • Cancer Center of the Carolinas
  • Sarah Cannon Research Institute
  • Intermountain Healthcare
  • Hospital Italiano de La Plata
  • Hospital General de Agudos "Dr. Teodoro Alvarez"
  • Clinical Hematology Service
  • Hospital Provincial de Cordoba
  • Sanatorio Parque
  • The Canberra Hospital
  • Royal North Shore Hospital
  • Westmead Hospital
  • Royal Adelaide Hospital
  • Box Hill Hospital
  • Peter MacCallum Cancer Centre
  • The Alfred Hospital
  • Royal Perth Hospital
  • LKH-Universitats Klinikum Graz
  • Landeskrankenhaus Salzburg
  • Landesklinikum St. Polten
  • Algemeen Ziekenhuis Sint-Jan
  • Institut Jules Bordet
  • University Hospital Gent
  • UCL de Mont-Godinne
  • London Health Sciences Centre
  • QEII Center for Clinical Research
  • The Ottawa Hospital - General Campus
  • Hospital Santa Maria
  • Hospital DIPRECA
  • Hospital Dr. Gustavo Fricke
  • University Hospital Kralovske Vinohrady Prague
  • General University Hospital Prague
  • Institute of Haematology and Blood Transfusion Prague
  • Instituto Ecuatoriano de Seguridad Social Hospital Regional Teodoro Maldonado Carbó
  • Hospital Carlos Andrade Marin
  • Hospital Militar
  • North Estonia Medical Centre Foundation
  • Hopital de Versailles
  • Hopital Sud
  • Hopital Edouard Herriot
  • Hopital-DIEU
  • Hopital du Haut Leveque
  • Hopital Bretonneau - CHRU de Tours
  • Charite - Campus Benjamin Franklin
  • Campus Virchow Klinikum
  • Evangelische Kliniken GmbH
  • St Antonius Hospital
  • Universitatsklinikum Essen
  • Stadtische Kliniken Frankfurt
  • Asklepios Kliniken Altona
  • Medizin Hochschule Hannover
  • Universitätsklinikum Schleswig-Holstein
  • Klinikum Leverkusen
  • Markische Kliniken GmbH Klinikim Ludenscheid
  • Universitätsmedizin Mannheim
  • Szent Istvan and Szent Laszlo Corporate Hospital - Out-patient Clinic of the Municipality Government
  • Petz Aladar County Teaching Hospital
  • Kaposi Mór County Teaching Hospital
  • University of Pecs
  • Rambam Medical Center
  • Hadassah Medical Center
  • Chaim Sheba Medical Center
  • University of Brescia
  • A.O.U Careggi
  • A.O.U San Martino
  • A.O. Cardarelli
  • A.O. San Salvatore
  • A.O.U Pisana Santa Chiara
  • Università degli Studi di Roma "La Sapienza"
  • Ospedale S. Eugenio
  • Istituto Clinico Humanitas
  • Inje University Busan Paik Hospital
  • Seoul National University Hospital
  • Severance Hospital in YUHS
  • Samsung Medical Center
  • Asan Medical Center
  • Ewha Womans University Mokdong Hospital
  • Ajou University Hospital
  • Teaching Hospital of the Medical University in Bialystok
  • Academic Clinical Centre - Teaching Hospital of the Medical University of Gdansk
  • Nicolaus Copernicus Provincial Specialist Hospital in Lodz
  • Provincial Hospital in Opole
  • Poznan Stare Miasto Health Care Facility
  • Janusz Korczak Provincial Specialist Hospital
  • Military Institue of Health Services
  • Institute of Hematology and Transfusiology
  • Independent Public University Hospital No. 1 in Wroclaw
  • Dr. Constantin Opris County Emergency Hospital, Internal Medicine Department
  • Brasov County Emergency Clinical Hospital
  • Colentina Clinical Hospital, Internal Medicine Department
  • Fundeni Clinical Institute "Stefan Berceanu" Center for Hematology and Bone Marrow Transplant
  • Coltea Clinical Hospital
  • Sibiu County Clinical Hospital, Internal Clinic II
  • State Medical Institution Republican Hospital n.a. V.A. Baranov
  • Municipal Medical Institution Municipal Hospital #1
  • State Medical Institution Sverdlovsk Regional Clinical Hospital #1
  • State Medical Institution Irkutsk Regional Clinical Hospital
  • State Medical Institution Territorial Clinical Hospital #1
  • State Medical Institution Territorial Clinical Oncological Center
  • State Institution Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences
  • Moscow State Medical Institution Municipal
  • Municipal Medical Institution
  • State Higher Educational Instution Rostov State
  • State Medical Institution Leningrad Regional Clinical Hospital
  • State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development
  • Federal Center of Heart, Blood and Endocrinology
  • Hospital Germans Trias i Pujol
  • Hospital Del Mar
  • Hospital Vall d'Hebron
  • Hospital Clinic I Provinicial
  • Hospital de la Santa Creu I Sant Pau
  • Hospital Universitario La Fe
  • Chang Gung Memorial Hospital Kao Hsiung Branch
  • Changhua Christian Hospital (CCH)
  • Chinese Medical University Hospital (CMUH)
  • National Cheng Kung University Hospital (NCKUH)
  • National Taiwan University Hospital (NTUH)
  • Mackay Memorial Hospital
  • Veterans General Hospital Taipei (VGH-TP)
  • Public Institution 'Cherkasy Regional Oncology Center'
  • Dnipropetrovsk City General Clinical Hospital #4
  • Ivano-Frankivsk State Medical University
  • Khmelnytsky Regional Hospital
  • State Institution 'Institute of Blood Pathology and Transfusion Medicine under the UAMS'
  • Mykolaiv Regional Clinical Hospital
  • Odesa Regional Clinical Hospital
  • Ukrainian Medical Academy of Dentistry
  • M.I. Pyrohov Vinnytsya Regional Clinical Hospital
  • O.F. Herbachevsky Zhytomyr Regional Clinical Hospital
  • University Hospital of Wales
  • King's College Hospital
  • Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A

Arm B

Arm Description

Amonafide in Combination with Cytarabine

Daunorubicin in Combination with Cytarabine

Outcomes

Primary Outcome Measures

Rate of CR + CRi (which includes CRc and CRd) will be determined by assessing the proportion of patients who achieved CR or CRi among all evaluable patients.

Secondary Outcome Measures

Median duration of remission and median duration of disease free survival.

Full Information

First Posted
July 14, 2008
Last Updated
October 12, 2010
Sponsor
Antisoma Research
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1. Study Identification

Unique Protocol Identification Number
NCT00715637
Brief Title
Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study
Official Title
Phase III Open-Label Randomized Study of Amonafide L-Malate in Combination With Cytarabine Compared to Daunorubicin in Combination With Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- The ACCEDE Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Antisoma Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Amonafide is a DNA intercalating agent and inhibitor of topoisomerase II that has been extensively studied in patients with malignant solid tumors. Amonafide has also been studied in patients with AML. The purpose of this study is to assess the relative efficacy and safety of amonafide in combination with cytarabine compared to daunorubicin with cytarabine in subjects with documented secondary AML.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Acute Myeloid Leukemia (Secondary AML, sAML)
Keywords
AML, Leukemia, MDS, Amonafide, Cytarabine, Daunorubicin, Lymphatic disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm A
Arm Type
Experimental
Arm Description
Amonafide in Combination with Cytarabine
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
Daunorubicin in Combination with Cytarabine
Intervention Type
Drug
Intervention Name(s)
Daunorubicin and Cytarabine
Intervention Description
Daunorubicin: 45 mg/m2 over 30 minutes daily on days 1-3 (up to max. of 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on days 1-7 (up to max. of 2 courses)
Intervention Type
Drug
Intervention Name(s)
Amonafide and Cytarabine
Intervention Description
Amonafide: 600 mg/m2 IV over 4 hours daily on Days 1-5 (up to max. 2 courses) Cytarabine: 200 mg/m2 IV continuous infusion daily on Days 1-7 (up to max. 2 courses)
Primary Outcome Measure Information:
Title
Rate of CR + CRi (which includes CRc and CRd) will be determined by assessing the proportion of patients who achieved CR or CRi among all evaluable patients.
Time Frame
Course 1/Course 2 Day 37 bone marrow assessments and confirmation bone marrow 30 days later
Secondary Outcome Measure Information:
Title
Median duration of remission and median duration of disease free survival.
Time Frame
Follow-up visits following post-remission therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of AML according to WHO diagnostic criteria (at least 20% blasts in the peripheral blood or bone marrow), with FAB classification other than M3 (Acute Promyelocytic Leukemia), documented by bone marrow aspiration and biopsy performed within 14 days prior to administration of 1st dose of remission induction chemotherapy; Either: Known and documented exposure to specific leukemogenic therapy of a specified nature for a non-myeloid condition; OR Documented diagnosis of MDS according to WHO criteria for at least 3 months prior to study entry, with prior bone marrow aspirate, biopsy and peripheral blood smear documenting MDS available to be submitted for subsequent central pathology review. Age 18 years or older; Eastern Cooperative Oncology Group (ECOG) performance score =< 2; Fertile sexually active patients (men and women) must use an effective method of contraception which must be continued throughout the study. Women of childbearing potential must have a negative serum pregnancy test. Left Ventricular Ejection Fraction (LVEF) >= 50%, as determined by multiple-gated acquisition scan (MUGA) or echocardiogram (ECHO) within 14 days prior to administration of 1st dose of remission induction chemotherapy; Adequate renal function as evidenced by the following laboratory test, obtained within 10 days prior to administration of 1st dose of remission induction chemotherapy: Serum creatinine =< 1.5 x ULN; Adequate hepatic function as evidenced by the following laboratory tests, obtained within 10 days prior to administration of 1st dose of remission induction chemotherapy (unless attributed to hepatic involvement with AML): Total serum bilirubin =< 1.5 x ULN;Serum AST and ALT =< 1.5 x ULN; Ability of the patient to participate fully in all aspects of this clinical trial; Written Informed Consent and HIPAA authorization (USA sites only) must be obtained and documented. Exclusion Criteria: Histologic diagnosis of FAB M3 Acute Promyelocytic Leukemia; Clinically active CNS leukemia; Prior induction therapy for AML; Known HIV positive; Known active hepatitis B or C, or any other active liver disease; Patients with parenchymal abnormality on screening chest x-ray must have no evidence of pulmonary infection on chest tomography (CT) prior to starting remission induction therapy. Any major surgery or radiation therapy within 4 weeks prior to study entry; Prior cytotoxic chemotherapy for MDS within 4 weeks prior to study entry (patients with rapidly rising blast count may be enrolled within 4 weeks of prior cytotoxic chemotherapy with waiver from the Medical Monitor); Persistent chronic non-hematologic toxicity (other than alopecia) greater than grade 1 from prior therapy for MDS; Serious concomitant illnesses (for example, pulmonary infiltrate, unstable angina or myocardial infarction or stroke within 3 months prior to study entry, congestive heart failure AHA class 2 or greater, uncontrolled hypertension, uncontrolled diabetes, actively bleeding gastric ulcer, etc.), which in the investigator's opinion would not make the patient a good candidate for the trial; Pregnant or breast feeding; History of clinically significant allergic reactions attributed to compounds of similar chemical or biological composition to amonafide, cytarabine or daunorubicin; Prior enrollment in this trial; Any other known condition (e.g., familial, sociological, or geographical) or behavior (including substance dependence or abuse, psychological or psychiatric illness), which in the investigator's opinion would make the patient a poor candidate for the trial.
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angelas
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Univ of Southern California Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
University of Colorado Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Rocky Mountain Blood and Marrow Transplant Program
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Winship Cancer Institute, Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Blood and Marrow Transplant Group of GA
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern University School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Iowa Hospitals
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
James Graham Brown Cancer Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
LSU Health Sciences Center, Feist-Weiller Cancer Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Michigan State University
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Northshore Hospital - Monter Cancer Center
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Taussig Cancer Center, Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17036
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Roger Williams Medical Center
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Cancer Center of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Intermountain Healthcare
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84103
Country
United States
Facility Name
Hospital Italiano de La Plata
City
Buenos Aires
ZIP/Postal Code
B1900AXI
Country
Argentina
Facility Name
Hospital General de Agudos "Dr. Teodoro Alvarez"
City
Ciudad Autónoma de Bs. As.
ZIP/Postal Code
C1406FWY
Country
Argentina
Facility Name
Clinical Hematology Service
City
Ciudad Autónoma de Bs. As.
ZIP/Postal Code
C1437JCP
Country
Argentina
Facility Name
Hospital Provincial de Cordoba
City
Cordoba
Country
Argentina
Facility Name
Sanatorio Parque
City
Rosario - Santa Fe
ZIP/Postal Code
S2000DSU
Country
Argentina
Facility Name
The Canberra Hospital
City
Garran
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Royal North Shore Hospital
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
Country
Australia
Facility Name
Peter MacCallum Cancer Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
LKH-Universitats Klinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Landeskrankenhaus Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Landesklinikum St. Polten
City
St. Polten
ZIP/Postal Code
3100
Country
Austria
Facility Name
Algemeen Ziekenhuis Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Institut Jules Bordet
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
University Hospital Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UCL de Mont-Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
QEII Center for Clinical Research
City
Halifax
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
The Ottawa Hospital - General Campus
City
Ottawa
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Hospital Santa Maria
City
Santiago
ZIP/Postal Code
7530204
Country
Chile
Facility Name
Hospital DIPRECA
City
Santiago
ZIP/Postal Code
7571831
Country
Chile
Facility Name
Hospital Dr. Gustavo Fricke
City
Viña del Mar
ZIP/Postal Code
2570017
Country
Chile
Facility Name
University Hospital Kralovske Vinohrady Prague
City
Prague
ZIP/Postal Code
100 34
Country
Czech Republic
Facility Name
General University Hospital Prague
City
Prague
ZIP/Postal Code
128 08
Country
Czech Republic
Facility Name
Institute of Haematology and Blood Transfusion Prague
City
Prague
Country
Czech Republic
Facility Name
Instituto Ecuatoriano de Seguridad Social Hospital Regional Teodoro Maldonado Carbó
City
Guayaquil
Country
Ecuador
Facility Name
Hospital Carlos Andrade Marin
City
Quito
Country
Ecuador
Facility Name
Hospital Militar
City
Quito
Country
Ecuador
Facility Name
North Estonia Medical Centre Foundation
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Hopital de Versailles
City
Versailles
State/Province
Le Cheaney
ZIP/Postal Code
78150
Country
France
Facility Name
Hopital Sud
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
Hopital-DIEU
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Hopital du Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Hopital Bretonneau - CHRU de Tours
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Charite - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Evangelische Kliniken GmbH
City
Bonn
ZIP/Postal Code
53113
Country
Germany
Facility Name
St Antonius Hospital
City
Eschweiler
ZIP/Postal Code
52249
Country
Germany
Facility Name
Universitatsklinikum Essen
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Stadtische Kliniken Frankfurt
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Asklepios Kliniken Altona
City
Hamburg
ZIP/Postal Code
22763
Country
Germany
Facility Name
Medizin Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
ZIP/Postal Code
24116
Country
Germany
Facility Name
Klinikum Leverkusen
City
Leverkusen
ZIP/Postal Code
51375
Country
Germany
Facility Name
Markische Kliniken GmbH Klinikim Ludenscheid
City
Lüdenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Universitätsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
D-68167
Country
Germany
Facility Name
Szent Istvan and Szent Laszlo Corporate Hospital - Out-patient Clinic of the Municipality Government
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Petz Aladar County Teaching Hospital
City
Győr
ZIP/Postal Code
9024
Country
Hungary
Facility Name
Kaposi Mór County Teaching Hospital
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
University of Pecs
City
Pecs
Country
Hungary
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
University of Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
A.O.U Careggi
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
A.O.U San Martino
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O. Cardarelli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. San Salvatore
City
Pesaro
ZIP/Postal Code
61100
Country
Italy
Facility Name
A.O.U Pisana Santa Chiara
City
Pisa
ZIP/Postal Code
56125
Country
Italy
Facility Name
Università degli Studi di Roma "La Sapienza"
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Ospedale S. Eugenio
City
Rome
ZIP/Postal Code
00144
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Inje University Busan Paik Hospital
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-799
Country
Korea, Republic of
Facility Name
Severance Hospital in YUHS
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
Teaching Hospital of the Medical University in Bialystok
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Academic Clinical Centre - Teaching Hospital of the Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Nicolaus Copernicus Provincial Specialist Hospital in Lodz
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Provincial Hospital in Opole
City
Opole
ZIP/Postal Code
45-372
Country
Poland
Facility Name
Poznan Stare Miasto Health Care Facility
City
Poznan
ZIP/Postal Code
61-833
Country
Poland
Facility Name
Janusz Korczak Provincial Specialist Hospital
City
Slupsk
ZIP/Postal Code
76-200
Country
Poland
Facility Name
Military Institue of Health Services
City
Warsaw
ZIP/Postal Code
00-909
Country
Poland
Facility Name
Institute of Hematology and Transfusiology
City
Warsaw
ZIP/Postal Code
02-776
Country
Poland
Facility Name
Independent Public University Hospital No. 1 in Wroclaw
City
Wroclaw
ZIP/Postal Code
50-369
Country
Poland
Facility Name
Dr. Constantin Opris County Emergency Hospital, Internal Medicine Department
City
Baia Mare
ZIP/Postal Code
430031
Country
Romania
Facility Name
Brasov County Emergency Clinical Hospital
City
Brasov
ZIP/Postal Code
500236
Country
Romania
Facility Name
Colentina Clinical Hospital, Internal Medicine Department
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Fundeni Clinical Institute "Stefan Berceanu" Center for Hematology and Bone Marrow Transplant
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Coltea Clinical Hospital
City
Bucharest
ZIP/Postal Code
030171
Country
Romania
Facility Name
Sibiu County Clinical Hospital, Internal Clinic II
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
State Medical Institution Republican Hospital n.a. V.A. Baranov
City
Petrozavodsk
State/Province
Republic of Karelia
ZIP/Postal Code
185014
Country
Russian Federation
Facility Name
Municipal Medical Institution Municipal Hospital #1
City
Cherepovets
ZIP/Postal Code
162627
Country
Russian Federation
Facility Name
State Medical Institution Sverdlovsk Regional Clinical Hospital #1
City
Ekaterinburg
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
State Medical Institution Irkutsk Regional Clinical Hospital
City
Irkutsk
ZIP/Postal Code
664079
Country
Russian Federation
Facility Name
State Medical Institution Territorial Clinical Hospital #1
City
Khabarovsk
ZIP/Postal Code
680009
Country
Russian Federation
Facility Name
State Medical Institution Territorial Clinical Oncological Center
City
Krasnodar
ZIP/Postal Code
350040
Country
Russian Federation
Facility Name
State Institution Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Moscow State Medical Institution Municipal
City
Moscow
ZIP/Postal Code
125101
Country
Russian Federation
Facility Name
Municipal Medical Institution
City
Perm
ZIP/Postal Code
614010
Country
Russian Federation
Facility Name
State Higher Educational Instution Rostov State
City
Rostow Am Don
Country
Russian Federation
Facility Name
State Medical Institution Leningrad Regional Clinical Hospital
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development
City
St. Petersburg
ZIP/Postal Code
197101
Country
Russian Federation
Facility Name
Federal Center of Heart, Blood and Endocrinology
City
St. Petersburg
Country
Russian Federation
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic I Provinicial
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
Country
Spain
Facility Name
Chang Gung Memorial Hospital Kao Hsiung Branch
City
Niao-Sung Hsiang
State/Province
Kaohsiung Hsien
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Changhua Christian Hospital (CCH)
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Chinese Medical University Hospital (CMUH)
City
Taichung City
ZIP/Postal Code
404
Country
Taiwan
Facility Name
National Cheng Kung University Hospital (NCKUH)
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
National Taiwan University Hospital (NTUH)
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Mackay Memorial Hospital
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Veterans General Hospital Taipei (VGH-TP)
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Public Institution 'Cherkasy Regional Oncology Center'
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Dnipropetrovsk City General Clinical Hospital #4
City
Dnipropetrovsk
ZIP/Postal Code
49102
Country
Ukraine
Facility Name
Ivano-Frankivsk State Medical University
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Khmelnytsky Regional Hospital
City
Khmelnytsky
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
State Institution 'Institute of Blood Pathology and Transfusion Medicine under the UAMS'
City
Lviv
ZIP/Postal Code
79044
Country
Ukraine
Facility Name
Mykolaiv Regional Clinical Hospital
City
Mykolaiv
ZIP/Postal Code
54058
Country
Ukraine
Facility Name
Odesa Regional Clinical Hospital
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Ukrainian Medical Academy of Dentistry
City
Poltava
Country
Ukraine
Facility Name
M.I. Pyrohov Vinnytsya Regional Clinical Hospital
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
O.F. Herbachevsky Zhytomyr Regional Clinical Hospital
City
Zhytomyr
ZIP/Postal Code
10013
Country
Ukraine
Facility Name
University Hospital of Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
ZIP/Postal Code
OX3 9DLJ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25732165
Citation
Stone RM, Mazzola E, Neuberg D, Allen SL, Pigneux A, Stuart RK, Wetzler M, Rizzieri D, Erba HP, Damon L, Jang JH, Tallman MS, Warzocha K, Masszi T, Sekeres MA, Egyed M, Horst HA, Selleslag D, Solomon SR, Venugopal P, Lundberg AS, Powell B. Phase III open-label randomized study of cytarabine in combination with amonafide L-malate or daunorubicin as induction therapy for patients with secondary acute myeloid leukemia. J Clin Oncol. 2015 Apr 10;33(11):1252-7. doi: 10.1200/JCO.2014.57.0952. Epub 2015 Mar 2.
Results Reference
derived
PubMed Identifier
25550361
Citation
Lindsley RC, Mar BG, Mazzola E, Grauman PV, Shareef S, Allen SL, Pigneux A, Wetzler M, Stuart RK, Erba HP, Damon LE, Powell BL, Lindeman N, Steensma DP, Wadleigh M, DeAngelo DJ, Neuberg D, Stone RM, Ebert BL. Acute myeloid leukemia ontogeny is defined by distinct somatic mutations. Blood. 2015 Feb 26;125(9):1367-76. doi: 10.1182/blood-2014-11-610543. Epub 2014 Dec 30.
Results Reference
derived

Learn more about this trial

Phase III Randomized Study of Amonafide (AS1413) and Cytarabine Versus Daunorubicin and Cytarabine in Patients With Secondary Acute Myeloid Leukemia (AML)- the ACCEDE Study

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