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AzTrials

Secondary Acute Myeloid Leukemia (Secondary AML, sAML)Phase 3NCT00715637

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

A Phase 3 study testing Daunorubicin and Cytarabine and Amonafide and Cytarabine in people with Secondary Acute Myeloid Leukemia (Secondary AML, sAML), run by Antisoma Research at 158 sites in 23 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Daunorubicin and Cytarabine and Amonafide and Cytarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
420 participants
Where
158 sitesin 23 countries
Study dates
Jun 2007to Jun 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

158 sites in 23 countries.

158 sites in 23 countries

United States30 sites

  • University of Michigan Cancer Center

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • The Blood and Marrow Transplant Group of GA

    Atlanta, Georgia, 30342

  • University of Colorado Health Sciences Center

    Aurora, Colorado, 80045

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02114

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University School of Medicine

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Taussig Cancer Center, Cleveland Clinic

    Cleveland, Ohio, 44195

  • Rocky Mountain Blood and Marrow Transplant Program

    Denver, Colorado, 80218

  • Duke University Medical Center

    Durham, North Carolina, 27707

  • Cancer Center of the Carolinas

    Greenville, South Carolina, 29605

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17036

  • University of Iowa Hospitals

    Iowa City, Iowa, 52242

  • Northshore Hospital - Monter Cancer Center

    Lake Success, New York, 11042

  • Michigan State University

    Lansing, Michigan, 48910

  • UCLA Medical Center

    Los Angelas, California, 90095

  • Univ of Southern California Comprehensive Cancer Center

    Los Angeles, California, 90033

  • James Graham Brown Cancer Center

    Louisville, Kentucky, 40202

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Western Pennsylvania Hospital

    Pittsburgh, Pennsylvania, 15224

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Roger Williams Medical Center

    Providence, Rhode Island, 02908

  • Intermountain Healthcare

    Salt Lake City, Utah, 84103

  • University of California San Francisco

    San Francisco, California, 94143

  • LSU Health Sciences Center, Feist-Weiller Cancer Center

    Shreveport, Louisiana, 71103

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Russia13 sites

  • Municipal Medical Institution Municipal Hospital #1

    Cherepovets, 162627

  • State Medical Institution Irkutsk Regional Clinical Hospital

    Irkutsk, 664079

  • State Medical Institution Territorial Clinical Hospital #1

    Khabarovsk, 680009

  • State Medical Institution Territorial Clinical Oncological Center

    Krasnodar, 350040

  • State Institution Russian Oncological Research Center n.a. N.N. Blokhin of the Russian Academy of Medical Sciences

    Moscow, 115478

  • Moscow State Medical Institution Municipal

    Moscow, 125101

  • Municipal Medical Institution

    Perm, 614010

  • State Medical Institution Republican Hospital n.a. V.A. Baranov

    Petrozavodsk, Republic of Karelia, 185014

  • State Higher Educational Instution Rostov State

    Rostov-on-Don

  • State Medical Institution Leningrad Regional Clinical Hospital

    Saint Petersburg, 194291

  • State Higher Educational Institution St. Petersburg State Medical University n.a. I.P. Pavlov under the Federal Agency for Healthcare and Social Development

    Saint Petersburg, 197101

  • Federal Center of Heart, Blood and Endocrinology

    Saint Petersburg

  • State Medical Institution Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, 620102

Other trials in Russia

Germany12 sites

  • Charite - Campus Benjamin Franklin

    Berlin, 12200

  • Campus Virchow Klinikum

    Berlin, 13353

  • Evangelische Kliniken GmbH

    Bonn, 53113

  • St Antonius Hospital

    Eschweiler, 52249

  • Universitatsklinikum Essen

    Essen, 45122

  • Stadtische Kliniken Frankfurt

    Frankfurt, 65929

  • Asklepios Kliniken Altona

    Hamburg, 22763

  • Medizin Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24116

  • Klinikum Leverkusen

    Leverkusen, 51375

  • Markische Kliniken GmbH Klinikim Ludenscheid

    Lüdenscheid, 58515

  • Universitätsmedizin Mannheim

    Mannheim, D-68167

Other trials in Germany

Ukraine10 sites

  • Public Institution 'Cherkasy Regional Oncology Center'

    Cherkasy, 18009

  • Dnipropetrovsk City General Clinical Hospital #4

    Dnipropetrovsk, 49102

  • Ivano-Frankivsk State Medical University

    Ivano-Frankivsk, 76018

  • Khmelnytsky Regional Hospital

    Khmelnytsky, 29000

  • State Institution 'Institute of Blood Pathology and Transfusion Medicine under the UAMS'

    Lviv, 79044

  • Mykolaiv Regional Clinical Hospital

    Mykolaiv, 54058

  • Odesa Regional Clinical Hospital

    Odesa, 65025

  • Ukrainian Medical Academy of Dentistry

    Poltava

  • M.I. Pyrohov Vinnytsya Regional Clinical Hospital

    Vinnytsia, 21018

  • O.F. Herbachevsky Zhytomyr Regional Clinical Hospital

    Zhytomyr, 10013

Other trials in Ukraine

Italy9 sites

  • University of Brescia

    Brescia, 25123

  • A.O.U Careggi

    Florence, 50134

  • A.O.U San Martino

    Genova, 16132

  • A.O. Cardarelli

    Naples, 80131

  • A.O. San Salvatore

    Pesaro, 61100

  • A.O.U Pisana Santa Chiara

    Pisa, 56125

  • Università degli Studi di Roma "La Sapienza"

    Roma, 00161

  • Ospedale S. Eugenio

    Rome, 00144

  • Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

Poland9 sites

  • Teaching Hospital of the Medical University in Bialystok

    Bialystok, 15-276

  • Academic Clinical Centre - Teaching Hospital of the Medical University of Gdansk

    Gdansk, 80-952

  • Nicolaus Copernicus Provincial Specialist Hospital in Lodz

    Lodz, 93-513

  • Provincial Hospital in Opole

    Opole, 45-372

  • Poznan Stare Miasto Health Care Facility

    Poznan, 61-833

  • Janusz Korczak Provincial Specialist Hospital

    Słupsk, 76-200

  • Military Institue of Health Services

    Warsaw, 00-909

  • Institute of Hematology and Transfusiology

    Warsaw, 02-776

  • Independent Public University Hospital No. 1 in Wroclaw

    Wroclaw, 50-369

Other trials in Poland

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Box Hill Hospital

    Box Hill, Victoria

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3002

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

South Korea7 sites

  • Inje University Busan Paik Hospital

    Busan, 614-735

  • Seoul National University Hospital

    Seoul, 110-799

  • Severance Hospital in YUHS

    Seoul, 120-752

  • Samsung Medical Center

    Seoul, 135-710

  • Asan Medical Center

    Seoul, 138-736

  • Ewha Womans University Mokdong Hospital

    Seoul, 158-710

  • Ajou University Hospital

    Suwon, 443-721

Other trials in South Korea

Taiwan7 sites

  • Changhua Christian Hospital (CCH)

    Changhua, 500

  • Chang Gung Memorial Hospital Kao Hsiung Branch

    Niao-Sung Hsiang, Kaohsiung Hsien, 83301

  • Chinese Medical University Hospital (CMUH)

    Taichung, 404

  • National Cheng Kung University Hospital (NCKUH)

    Tainan, 704

  • National Taiwan University Hospital (NTUH)

    Taipei, 100

  • Mackay Memorial Hospital

    Taipei, 104

  • Veterans General Hospital Taipei (VGH-TP)

    Taipei, 112

Other trials in Taiwan

France6 sites

  • Hopital Sud

    Amiens, 80054

  • Hopital Edouard Herriot

    Lyon, 69437

  • Hopital-DIEU

    Paris, 75004

  • Hopital du Haut Leveque

    Pessac, 33604

  • Hopital Bretonneau - CHRU de Tours

    Tours, 37044

  • Hopital de Versailles

    Versailles, Le Cheaney, 78150

Other trials in France

Romania6 sites

  • Dr. Constantin Opris County Emergency Hospital, Internal Medicine Department

    Baia Mare, 430031

  • Brasov County Emergency Clinical Hospital

    Brasov, 500236

  • Colentina Clinical Hospital, Internal Medicine Department

    Bucharest, 020125

  • Fundeni Clinical Institute "Stefan Berceanu" Center for Hematology and Bone Marrow Transplant

    Bucharest, 022328

  • Coltea Clinical Hospital

    Bucharest, 030171

  • Sibiu County Clinical Hospital, Internal Clinic II

    Sibiu, 550245

Other trials in Romania

Spain6 sites

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Del Mar

    Barcelona, 08003

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic I Provinicial

    Barcelona, 08036

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08041

  • Hospital Universitario La Fe

    Valencia

Other trials in Spain

Argentina5 sites

  • Hospital Italiano de La Plata

    Buenos Aires, B1900AXI

  • Hospital General de Agudos "Dr. Teodoro Alvarez"

    Ciudad Autónoma de Bs. As., C1406FWY

  • Clinical Hematology Service

    Ciudad Autónoma de Bs. As., C1437JCP

  • Hospital Provincial de Cordoba

    Córdoba

  • Sanatorio Parque

    Rosario - Santa Fe, S2000DSU

Other trials in Argentina

Belgium4 sites

  • Algemeen Ziekenhuis Sint-Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • University Hospital Gent

    Ghent, Gent, 9000

  • UCL de Mont-Godinne

    Yvoir, 5530

Other trials in Belgium

Hungary4 sites

  • Szent Istvan and Szent Laszlo Corporate Hospital - Out-patient Clinic of the Municipality Government

    Budapest, 1097

  • Petz Aladar County Teaching Hospital

    Győr, 9024

  • Kaposi Mór County Teaching Hospital

    Kaposvár, 7400

  • University of Pecs

    Pécs

Other trials in Hungary

Austria3 sites

  • LKH-Universitats Klinikum Graz

    Graz, 8036

  • Landeskrankenhaus Salzburg

    Salzburg, 5020

  • Landesklinikum St. Polten

    Sankt Pölten, 3100

Other trials in Austria

Canada3 sites

  • QEII Center for Clinical Research

    Halifax, B3H 2Y9

  • London Health Sciences Centre

    London, Ontario, N6A 4L6

  • The Ottawa Hospital - General Campus

    Ottawa, K1H 8L6

Other trials in Canada

Chile3 sites

  • Hospital Santa Maria

    Santiago, 7530204

  • Hospital DIPRECA

    Santiago, 7571831

  • Hospital Dr. Gustavo Fricke

    Viña del Mar, 2570017

Other trials in Chile

Czechia3 sites

  • University Hospital Kralovske Vinohrady Prague

    Prague, 100 34

  • General University Hospital Prague

    Prague, 128 08

  • Institute of Haematology and Blood Transfusion Prague

    Prague

Other trials in Czechia

Ecuador3 sites

  • Instituto Ecuatoriano de Seguridad Social Hospital Regional Teodoro Maldonado Carbó

    Guayaquil

  • Hospital Carlos Andrade Marin

    Quito

  • Hospital Militar

    Quito

Other trials in Ecuador

Israel3 sites

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah Medical Center

    Jerusalem, 91120

  • Chaim Sheba Medical Center

    Tel HaShomer, 52621

Other trials in Israel

United Kingdom3 sites

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XW

  • King's College Hospital

    London, SE5 9RS

  • Churchill Hospital

    Oxford, OX3 9DLJ

Other trials in United Kingdom

Estonia1 site

  • North Estonia Medical Centre Foundation

    Tallinn, 13419

Other trials in Estonia

About this 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

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.

Being tested
Daunorubicin and Cytarabine, Amonafide and Cytarabine
Keywords
AML, Leukemia, MDS, Amonafide, Cytarabine, Daunorubicin, Lymphatic disorders
Medical subject headings
Leukemia, Lymphatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Daunorubicin and CytarabineDrug

    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)

  • Amonafide and CytarabineDrug

    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)

Study groups in NCT00715637
Study groupRoleWhat they receive
Arm AExperimentalAmonafide in Combination with Cytarabine
Receives: Drug: Amonafide and Cytarabine
Arm BActive comparatorDaunorubicin in Combination with Cytarabine
Receives: Drug: Daunorubicin and Cytarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Course 1/Course 2 Day 37 bone marrow assessments and confirmation bone marrow 30 days later

Secondary outcomes (1)

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

    Measured: Follow-up visits following post-remission therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2008 (estimated)
  2. Study startJun 2007
  3. Primary completionJun 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00715637
Sponsor's protocol ID
509912
Status last verified
Oct 2010
First submitted
14 Jul 2008
Last updated
13 Oct 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25732165

  • 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.

    PubMed 25550361

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daunorubicin and Cytarabine and Amonafide and Cytarabine in people with Secondary Acute Myeloid Leukemia (Secondary AML, sAML), run by Antisoma Research at 158 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in United States, Russia, Germany, Ukraine, Italy and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00715637, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2010.

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