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Status unknownNCT00715637Updated Oct 13, 2010

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 interventional study of Daunorubicin and Cytarabine and Amonafide and Cytarabine in Secondary Acute Myeloid Leukemia (Secondary AML, sAML), sponsored by Antisoma Research. Status unknown at 158 sites in 23 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-10-13.

Sponsored by Antisoma Research · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Secondary Acute Myeloid Leukemia (Secondary AML, sAML)

Keywords

  • AML
  • Leukemia
  • MDS
  • Amonafide
  • Cytarabine
  • Daunorubicin
  • Lymphatic disorders
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 637 are open to participants now.

This study's planned enrollment of 420 is above the median of 38 across 4,248 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Antisoma Research is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
420 participants (estimated)

Study arms

  • Experimental
    Arm A

    Amonafide in Combination with Cytarabine

    Drug: Amonafide and Cytarabine

  • Active comparator
    Arm B

    Daunorubicin in Combination with Cytarabine

    Drug: Daunorubicin and Cytarabine

Interventions

  • DrugDaunorubicin and Cytarabine

    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)

  • DrugAmonafide and Cytarabine

    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)

06

What researchers measure

Primary outcomes

  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.

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

Secondary outcomes

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

    Time frame: Follow-up visits following post-remission therapy

07

Study locations

158 sites
  • UCLA Medical Center
    Los Angelas, California 90095, United States
  • Univ of Southern California Comprehensive Cancer Center
    Los Angeles, California 90033, United States
  • University of California San Francisco
    San Francisco, California 94143, United States
  • University of Colorado Health Sciences Center
    Aurora, Colorado 80045, United States
  • Rocky Mountain Blood and Marrow Transplant Program
    Denver, Colorado 80218, United States
  • Winship Cancer Institute, Emory University
    Atlanta, Georgia 30322, United States
  • The Blood and Marrow Transplant Group of GA
    Atlanta, Georgia 30342, United States
  • Northwestern University School of Medicine
    Chicago, Illinois 60611, United States
  • Rush University Medical Center
    Chicago, Illinois 60612, United States
  • University of Iowa Hospitals
    Iowa City, Iowa 52242, United States
  • James Graham Brown Cancer Center
    Louisville, Kentucky 40202, United States
  • LSU Health Sciences Center, Feist-Weiller Cancer Center
    Shreveport, Louisiana 71103, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02114, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • University of Michigan Cancer Center
    Ann Arbor, Michigan 48109, United States
  • Michigan State University
    Lansing, Michigan 48910, United States
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
  • Northshore Hospital - Monter Cancer Center
    Lake Success, New York 11042, United States
  • Duke University Medical Center
    Durham, North Carolina 27707, United States
  • Wake Forest University Health Sciences
    Winston-Salem, North Carolina 27157, United States
  • Taussig Cancer Center, Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • Penn State Hershey Medical Center
    Hershey, Pennsylvania 17036, United States
  • Thomas Jefferson University
    Philadelphia, Pennsylvania 19107, United States
  • Western Pennsylvania Hospital
    Pittsburgh, Pennsylvania 15224, United States
  • Roger Williams Medical Center
    Providence, Rhode Island 02908, United States
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Cancer Center of the Carolinas
    Greenville, South Carolina 29605, United States
  • Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
  • Intermountain Healthcare
    Salt Lake City, Utah 84103, United States
  • Hospital Italiano de La Plata
    Buenos Aires, B1900AXI, Argentina
  • Hospital General de Agudos "Dr. Teodoro Alvarez"
    Ciudad Autónoma de Bs. As., C1406FWY, Argentina
  • Clinical Hematology Service
    Ciudad Autónoma de Bs. As., C1437JCP, Argentina
  • Hospital Provincial de Cordoba
    Cordoba, Argentina
  • Sanatorio Parque
    Rosario - Santa Fe, S2000DSU, Argentina
  • The Canberra Hospital
    Garran, Australian Capital Territory 2605, Australia
  • Royal North Shore Hospital
    St Leonards, New South Wales 2065, Australia
  • Westmead Hospital
    Westmead, New South Wales 2145, Australia
  • Royal Adelaide Hospital
    Adelaide, South Australia 5000, Australia
  • Box Hill Hospital
    Box Hill, Victoria, Australia
  • Peter MacCallum Cancer Centre
    Melbourne, Victoria 3002, Australia
  • The Alfred Hospital
    Melbourne, Victoria 3004, Australia
  • Royal Perth Hospital
    Perth, Western Australia 6000, Australia
  • LKH-Universitats Klinikum Graz
    Graz, 8036, Austria
  • Landeskrankenhaus Salzburg
    Salzburg, 5020, Austria
  • Landesklinikum St. Polten
    St. Polten, 3100, Austria
  • Algemeen Ziekenhuis Sint-Jan
    Brugge, 8000, Belgium
  • Institut Jules Bordet
    Brussels, 1000, Belgium
  • University Hospital Gent
    Gent, 9000, Belgium
  • UCL de Mont-Godinne
    Yvoir, 5530, Belgium
  • London Health Sciences Centre
    London, Ontario N6A 4L6, Canada
  • QEII Center for Clinical Research
    Halifax, B3H 2Y9, Canada
  • The Ottawa Hospital - General Campus
    Ottawa, K1H 8L6, Canada
  • Hospital Santa Maria
    Santiago, 7530204, Chile
  • Hospital DIPRECA
    Santiago, 7571831, Chile
  • Hospital Dr. Gustavo Fricke
    Viña del Mar, 2570017, Chile
  • University Hospital Kralovske Vinohrady Prague
    Prague, 100 34, Czech Republic
  • General University Hospital Prague
    Prague, 128 08, Czech Republic
  • Institute of Haematology and Blood Transfusion Prague
    Prague, Czech Republic
  • Instituto Ecuatoriano de Seguridad Social Hospital Regional Teodoro Maldonado Carbó
    Guayaquil, Ecuador
  • Hospital Carlos Andrade Marin
    Quito, Ecuador
  • Hospital Militar
    Quito, Ecuador
  • North Estonia Medical Centre Foundation
    Tallinn, 13419, Estonia
  • Hopital de Versailles
    Versailles, Le Cheaney 78150, France
  • Hopital Sud
    Amiens, 80054, France
  • Hopital Edouard Herriot
    Lyon, 69437, France
  • Hopital-DIEU
    Paris, 75004, France
  • Hopital du Haut Leveque
    Pessac, 33604, France
  • Hopital Bretonneau - CHRU de Tours
    Tours, 37044, France
  • Charite - Campus Benjamin Franklin
    Berlin, 12200, Germany
  • Campus Virchow Klinikum
    Berlin, 13353, Germany
  • Evangelische Kliniken GmbH
    Bonn, 53113, Germany
  • St Antonius Hospital
    Eschweiler, 52249, Germany
  • Universitatsklinikum Essen
    Essen, 45122, Germany
  • Stadtische Kliniken Frankfurt
    Frankfurt, 65929, Germany
  • Asklepios Kliniken Altona
    Hamburg, 22763, Germany
  • Medizin Hochschule Hannover
    Hannover, 30625, Germany
  • Universitätsklinikum Schleswig-Holstein
    Kiel, 24116, Germany
  • Klinikum Leverkusen
    Leverkusen, 51375, Germany
  • Markische Kliniken GmbH Klinikim Ludenscheid
    Lüdenscheid, 58515, Germany
  • Universitätsmedizin Mannheim
    Mannheim, D-68167, Germany
  • Szent Istvan and Szent Laszlo Corporate Hospital - Out-patient Clinic of the Municipality Government
    Budapest, 1097, Hungary
  • Petz Aladar County Teaching Hospital
    Győr, 9024, Hungary
  • Kaposi Mór County Teaching Hospital
    Kaposvár, 7400, Hungary
  • University of Pecs
    Pecs, Hungary
  • Rambam Medical Center
    Haifa, 31096, Israel
  • Hadassah Medical Center
    Jerusalem, 91120, Israel
  • Chaim Sheba Medical Center
    Tel Hashomer, 52621, Israel
  • University of Brescia
    Brescia, 25123, Italy
  • A.O.U Careggi
    Firenze, 50134, Italy
  • A.O.U San Martino
    Genova, 16132, Italy
  • A.O. Cardarelli
    Napoli, 80131, Italy
  • A.O. San Salvatore
    Pesaro, 61100, Italy
  • A.O.U Pisana Santa Chiara
    Pisa, 56125, Italy
  • Università degli Studi di Roma "La Sapienza"
    Roma, 00161, Italy
  • Ospedale S. Eugenio
    Rome, 00144, Italy
  • Istituto Clinico Humanitas
    Rozzano, 20089, Italy
  • Inje University Busan Paik Hospital
    Busan, 614-735, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 110-799, Korea, Republic of
  • Severance Hospital in YUHS
    Seoul, 120-752, Korea, Republic of

Showing the first 100 of 158 sites across 23 countries.

08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00715637
Lead sponsor
Antisoma Research
First posted
Jul 15, 2008
Start date
Jun 2007
Primary completion
Jun 2010 (estimated)
Last update
Oct 13, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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