SWOG clinical trial number
SWOG-9333

A Randomized Controlled Trial of Mitoxantrone and Etoposide versus Daunomycin and Cytosine Arabinoside as Induction Therapy in Patients Over Age 55 With Previously Untreated Acute Myeloid Leukemia, Phase III

Closed
Phase
III
Accrual
84%
Published
Abbreviated Title
Mito/VP-16 vs DNR/Ara-C for Elderly AML
Activated
01/15/1995
Closed
12/01/1998
Participants

Research committees

Leukemia

Treatment

Cytosine Arabinoside Daunomycin GM-CSF Mitoxantrone VP-16

Eligibility Criteria Expand/Collapse

Morphologically confirmed diagnosis AML (FAB class M3 not allowed), >= 56 years of age, bilirubin = 50 cc/min; eject. fraction >= 50%, must not have unstable cardiac arrhythmias or unstable angina; no prior chemo. for acute leukemia; prior hydroxyurea permitted for control of blood count; prior low dose Ara-C permitted for MDS (> 30 days must have elapsed and toxicities resolved); Slides for pathology and specimens for cytogenetics and cellular and molecular studies must be submitted.

Publication Information Expand/Collapse

2018

Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials

M Chavez-MacGregor;J Unger;A Moseley;S Ramsey;DL Hershman Cancer Apr 15;124(8):1760-1769; Jan 25 [Epub ahead of print]

PMid: PMID29370458 | PMC number: PMC5963502

Impact of specimen heterogeneity on biomarkers in repository samples from patients with AML: a SWOG report

E Pogosova-Agadjanyan;A Moseley;M Othus;F Appelbaum;T Chauncey;I-M Chen;HP Erba;J Godwin;M Fang;K Kopecky;AF List;G Pogosov;J Radich;C Willman;BL Wood;S Meshinchi;D Stirewalt Biopreservation and Biobanking Feb;16(1):42-52; Nov 27 [Epub ahead of print]

PMid: PMID29172682 | PMC number: PMC5808392

The association between ASCO Value framework and scientific and clinical impact of SWOG phase III clinical trials

V Nghiem;R Vaidya;M Banegas;D Hershman;J Unger AcademyHealth Annual Research Meeting (June 23-26, 2018, Seattle, WA), poster

Survival by Hispanic Ethnicity Among Cancer Patients participating in SWOG Clinical Trials

A Moseley;M Chavez-MacGregor;J Unger;S Ramsey;D Hershman Society for Clinical Trials Annual Meeting (May 20-23 2018, Portland, OR), oral presentation

2017

Association between body mass index and cancer survival in a pooled analysis of 22 clinical trials

H Greenlee;J Unger;M Leblanc;S Ramsey;D Hershman Cancer Epidemiology Biomarkers & Prevention 2017 Jan;26(1):21-29; 2016 Dec 16. [Epub ahead of print]

PMid: PMID27986655 | PMC number: PMC5370550

Prognostic methylation markers for survival in cytogenetically normal AML patients treated on SWOG trials

X Qu;M Othus;J Davison;Y Wu;L Yan;E Estey;J Radich;H Erba;F Appelbaum;M Fang Cancer Jul 1;123(13):2472-2481; 2017 Feb 21[Epub ahead of print]

PMid: PMID28222251; PMC5705230

Associations between Complete Remissions (CRs) with 7+3 Induction Chemotherapy for Acute Myeloid Leukemia and 2-3 Year Survival (“Potential Cure”) Over the Past Four Decades: Analysis SWOG Trial Data

M Othus;G Garcia-Manero;JE Godwin;J Weick;JE Anderson;DL Stirewalt;F Appelbaum;HP Erba;EH Estey Blood 2017 130:1301; American Society of Hematology Annual Meeting (December 9-12, 2017, Atlanta, GA), poster

2016

Prediction of CR following a second course of "7+3" in patients with newly diagnosed acute myeloid leukemia not in CR after a first course

M Othus;S Mukherjee;MA Sekeres;JE Godwin;SH Petersdorf;F Appelbaum;H Erba;E Estey Leukemia Aug;30(8):1779-1780; 2016 Feb 29 [Epub ahead of print]

PMid: PMID27055872 | PMC number: PMC4980556

Improved prognostic significance genomic and transcriptional prognostic biomarkers by examining enriched populations of AML blasts: a SWOG report

EL Pogosova-Agadjanyan;A Moseley;BL Wood;F Appelbaum;TR Chauncey;H Erba;J Godwin;M Fang;Kopecky;AF List;M Othus;J Radich;I-M Chen;CL Willman;S Meshinchi;D Stirewalt Blood 128:2890; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), poster

2015

Prognostic significance of NPM1 mutations in the absence of FLT3-Internal Tandem Duplication in older patients with acute myeloid leukemia: a SWOG and UK National Cancer Research Institute/Medical Research Council report

F Ostronoff;M Othus;A Burnett;E Estey;FR Appelbaum;A Evans;J Godwin;A Gilkes;K Kopecky;M Lazenby;AF List;M Fang;V Oehler;S Petersdorf;E Pogosova-Agadjanyan;J Radich;C Willman;S Meshinchi;DL Stirewalt Journal of Clinical Oncology, Apr 1;33(10):1157-1164

PMid: PMID25713434 | PMC number: PMC437285

Cell signalling-based classifier predicts response to induction therapy in elderly patients with acute myeloid leukemia

A Cesano;C Willman;K Kopecky;U Geyko;S Putta;B Louie;M Westfall;N Purvis;D Spellmeyer;C Marimpietri;J Hackett;J Shi;M Walker;X Sun;E Paietta;M Tallman;L Cripe;S Atwater;F Appelbaum;J Radich PLOS ONE 2015 Apr 17;10(4):e0118485. doi: 10.1371/journal.pone.0118485

PMid: PMID25884949 | PMC number: PMCID4401549

Resistance prediction in AML: analysis of 4,601 patients from MRC/NCRI, HOVON/SAKK, SWOG, and MD Anderson Cancer Center

R Walter;M Othus;AK Burnett;B Lowenberg;H Kantarjian;G Ossenkoppele;R Hills;F Ravandi;A Evans;SA Pierce;F Appelbaum;E Estey Leukemia 29(2):312-320

PMid: PMID25113226 | PMC number: PMC4318722

Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia

B Medeiros;M Othus;M Fang;F Appelbaum;H Erba Haematololgica Mar;100(3):331-335

PMid: PMID25527568 | PMC number: PMC4349271

Prognostic methylation markers for survival in cytogenetically normal AML patients treated on SWOG trials

X Qu;M Othus;J Davison;L Yan;E Estey;J Radich;H Erba;F Appelbaum;M Fang Blood 126(23):688; American Society of Hematology Annual Meeting (Dec 5-8, 2015, Orlando, FL), oral presentation;

2014

Unsuccessful cytogenetic analysis is a poor prognostic feature in acute myeloid leukemia

B Medeiros;M Othus;E Estey;M Fang;F Appelbaum British Journal of Haematology 28(2):245-250;

PMid: PMID24383844 | PMC number: PMC4117470

Declining rates of treatment-related mortality in patients with newly-diagnosed AML given "intense" induction regimens: a report from SWOG and MD Anderson

M Othus;H Kantarjian;S Petersdorf;F Ravandi;J Godwin;J Cortes;S Pierce;H Erba;S Faderl;F Appelbaum;E Estey Leukemia 28(2):289-292;

PMid: PMID23760400 | PMC number: PMC4457325

Comparison of survival outcomes among cancer patients treated in and out of clinical trials

J Unger;W Barlow;DP Martin;S Ramsey;M Leblanc;R Etzioni;D Hershman Journal of the National Cancer Institute 106(3):dju002; 2014 Mar 13 [Epub ahead of print];

PMid: PMID24627276 | PMC number: PMC3982777

Association between BMI at treatment initiation and cancer survival across multiple SWOG trials

H Greenlee;J Unger;M Leblanc;D Hershman AACR Research International Conference on Frontiers on Cancer Research Prevention (Sept 28-Oct 1, 2014, New Orleans, LA; poster

2013

The prognostic significance of IRF8 transcripts in adult patients with acute myeloid leukemia

E Pogosova-Agadjanyan;K Kopecky;S Meshinchi;F Appelbaum;J Anderson;J Godwin;H Lee;A List;V Oehler;S Petersdorf;J Radich;C Willman;D Stirewalt PlosOne 8(8):e70812;

PMid: PMID23967110 | PMC number: PMC3743845

Mutations in the DNMT3A exon 23 independently predict poor outcome in older AML patients: a SWOG report [Letter to the Editor]

F Ostronoff;M Othus;P Ho;DE Geraghty;SH Petersdorf;J Anderson;J Godwin;C Willman;G Radich;F Appelbaum;K Kopecky;DL Stirewalt;S Meshinchi Leukemia 27(1):238-241;

PMid: PMID22722750 | PMC number: PMC4457316

Significance of FAB subclassification of "acute myeloid leukemia, not otherwise specified" in the 2008 WHO classification: analysis of 5,848 newly diagnosed patients

RB Walter;M Othus;A Burnett;B Lowenberg;H Kantarjian;GJ Ossenkoppele;RK Hills;K van Montfort;F Ravandi;A Evans;SA Pierce;F Appelbaum;EH Estey Blood 121(13):2424-2431;

PMid: PMID23325837 | PMC number: PMC3612855

A model for prediction of FLT3-ITD and NPM1 (without FLT-3-ITD) positivity in patients with newly diagnosed acute myeloid leukemia [correspondence]

F Ostronoff;M Othus;HM Kantarjian;S Meshinchi;F Ravandi;P Hendrie;S Faderl;P Becker;JE Cortes;JM Pagel;SH Petersdorf;JE Godwin;C Willman;SA Pierce;AF List;RK Sandhu;R Walter;D Stirewalt;FR Appelbaum;EH Estey British Journal of Haematology 163(1):130-132;

PMid: PMID23829510 | PMC number: PMC4128010

Deregulation of stem cell factor (SCF)-AKT-S6 pathway in diagnostic AML samples is associated with disease-free survival: results of a verification study

A Cesano;C Willman;K Kopecky;S Putta;A Cohen;MC Marimpietri;S Atwater;F Appelbaum;G Radich Haematologica 98(suppl.1):abstr. #P956, p.396; European Hematology Association 18th Congress ( June 13-16, 2013, Stockholm, Sweden), poster presentation;

Prediction of CR on reinduction in patients with newly diagnosed acute myeloid leukemia given intensive induction regimens: a report from SWOG and Cleveland Clinic

M Othus;S Mukherjee;MA Sekeres;J Godwin;J Anderson;S Petersdorf;F Appelbaum;HP Erba;E Estey Blood 122:2686; American Society of Hematology meeting (Dec 7-10, 2013, New Orleans, LA), poster presentation;

Prediction of therapeutic resistance in adult acute myeloid leukemia: analysis of 4,550 newly diagnosed patients from MRC/NCRI, HOVON, SWOG, and MD Anderson Cancer Center

R Walter;M Othus;AK Burnett;AK Burnett;B Lowenberg;H Kantarjian;GJ Ossenkoppele;RK Hills;F Ravandi;A Evans;SA Pierce;F Appelbaum;E Estey Blood 122:64; American Society of Hematology annual meeting (Dec 7-10, 2013), oral;

Impact of cytarabine dose in the induction regimen on the outcome of patients with newly diagnosed acute myeloid leukemia with or without NPM1 and/or FLT3 mutations: A SWOG and MD Anderson Cancer Center Report

M Othus;F Ravandi;S Faderl;D Stirewalt;S Pierce;G Borthakur;J Godwin;J Anderson;S Petersdorf;J Cortes;F Ostronoff;E Pogosova-Agadijanyan;F Appelbaum;H Kantarjian;E Estey Blood 122:2686; American Society of Hematology annual meeting (Dec 7-10, 2013, New Orleans, LA), poster;

Prognostic significance of NPM1 mutations in the absence of FLT3-ITD in older patients with AML: a SWOG report

F Ostronoff;M Othus;S Meshinchi;J Godwin;K Kopecky;A List;V Oehler;S Petersdorf;E Pogosolva-Agadjanyan;J Radich;CL Willman;F Appelbaum;D Stirewalt Blood 122:1315; American Society of Hematology annual meeting (Dec 7-10, New Orleans, LA), poster;

Novel long-term co-culture approach identifies prognostically important heterogeneity of stem/progenitor cell involvement in human acute myeloid leukemia

GS Laszlo;JM Lionberger;BS Harrington;CJ Gudgeon;M Othus;F Appelbaum;ID Bernstein;R Walter Blood 122:1318; ASH annual meeting, poster presentaton

2012

Impact of residual normal metaphases in core binding factor acute myeloid leukemia

B Medeiros;M Othus;M Fang;F Appelbaum;E Estey Cancer 118(9):2420-2423;

PMid: PMID21928314 | PMC number: PMC3490403

Impact of body-mass index in the outcome of adult patients with acute myeloid leukemia

B Medeiros;M Othus;EH Estey;M Fang;F Appelbaum Haematologica 97(9):1401-1404

PMid: PMID22315487 | PMC number: PMCID3436242

A scoring system of prediction of FLT3-ITD positivity in patients with newly diagnosed acute myeloid leukemia: a SWOG, Fred Hutchinson and M.D. Anderson Cancer Center study

F Ostronoff;M Othus;S Meshinchi;F Appelbaum;E Estey Blood 120(21):abst. 2590; American Society of Hematology Annual Meeting, poster;

Declining rates of treatment-related mortality recent in patients with newly-diagnosed AML given "intense" induction regimens: a report from SWOG and MD Anderson

M Othus;H Kantarjian;S Petersdorf;F Ravandi;J Godwin;J Cortes;S Pierce;H Erba;S Faderl;F Appelbaum;E Estey Blood 120(21):abst. 129; American Society of Hematology Annual Meeting, oral;

Single-cell network profiling (SCNP)-based classifier to predict response to induction therapy in elderlly patients with acute myeloid leukemia (AML): validation in two independent sample sets from ECOG and SWOG trials

A Cesano;C Willman;K Kopecky;U Gayko;S Putta;B Louie;M Westfall;N Purvis;D Spellmeyer;C Marimpietri;J Hackett;J Shi;E Paietta;M Tallman;L Cripe;S Atwater;F Appelbaum;J Radich Blood 120(21):abst.2489; American Society of Hematology Annual Meeting, poster;

Prognostic significance of the French-American-British (FAB) morphologic subclassification of "acute myeloid leukemia, not otherwise specified" in the 2008 WHO classification: analysis of 5,848 newly diagnosed patients from HOVON, MRC, SWOG, and MD Anderson Cancer Center

R Walter;M Othus;AK Burnett;B Lowenberg;H Kantarjian;G Ossenkoppele;RK Hills;K van Montfort;F Ravandi;S Pierce;F Appelbaum;E Estey Blood 120(21)abst. 540; American Society of Hematology Annual Meeting, oral;

2011

Expression of topoisomerase II isoforms a and B in adult patients with acute myeloid leukemia (AML): relationship to immunophenotype and treatment outcome

A Michelson;K Kopecky;E Koegle;J Anderson;J Godwin;S Petersdorf;A List;C Willman;F Appelbaum;J Radich;M Ganapathi;R Ganapathi;A Advani Journal of Clinical Oncology 29:(suppl; abstr 6564) ASCO 2011 meeting, general poster presentation

Influence of residual normal metaphases in acute myeloid leukemia patients with monosomal karyotype [PMID21330329; PMC3069244]

B Xie;M Othus;B Medeiros;M Fang;F Appelbaum;E Estey Haematologica 96(4):631-632

Outcome of patients with acute myeloid leukemia with monosomal karyotype who undergo hematopoietic cell transplantation [PMID21680797;PMC3156042]

M Fang;B Storer;E Estey;M Othus;L Zhang;B Sandmaier;F Appelbaum Blood 118(6):1490-1494

Cytarabine dose for acute myeloid leukemia. (Letter to the Editor) [PMID21631340]

B Medeiros;M Othus;F Appelbaum New England Journal of Medicine 364(11):2167-2168

KIT mutations are very uncommon among elderly AML patients: a SWOG report

F Ostronoff;M Othus;PA Ho;S Petersdorf;JE Anderson;JE Godwin;CL Willman;JP Radich;F Appelbaum;D Stirewalt;S Meshinchi Blood 118(21):abstract 2510; American Society of Hematology (poster presentation);

DNMT3A mutations independently predict poor outcome in older AML patients: a SWOG report

F Ostronoff;M Othus;PA Ho;S Petersdorf;JE Anderson;JE Godwin;C Willman;J Radich;F Appelbaum;D Stirewalt;S Meshinchi Blood 118(210:abstract 3519); American Society of Hematology, poster presentation;

Prognostic import of French-American-British (FAB) system as embedded in 2008 revision of World Health Organization classification of AML

L Newell;M Othus;R Walter;E Petersdorf;T Chauncey;JE Anderson;JE Godwin;K Kopecky;F Appelbaum;E Estey Blood 118(21):abstract 1446; American Society of Hematology, poster presentation;

Prevalence and clinical implications of IDH1 R140 and R172 mutations in older adults with AML: a report from SWOG

PA Ho;M Othus;K Kopecky;F Ostronoff;S Petersdorf;JE Anderson;JE Godwin;CL Willman;JP Radich;F Appelbaum;D Stirewalt;S Meshinchi Blood 118(21):abstract 3516; American Society of Hematology, poster presenation;

Prediction of early death following induction therapy for newly diagnosed acute leukemia with pretreatment risk scores: a novel paradigm for treatment assignment

R Walter;M Othus;G Borthakur;F Ravandi;J Cortes;S Pierce;F Appelbaum;H Kantarjian;E Estey Journal of Clinical Oncology, 29(33):4417-23;

PMid: PMID21969499 | PMC number: PMC3221524

2010

Molecular alterations of the IDH1 gene in AML: a Children's Oncology Group and Southwest Oncology Group study[PMID20376086; PMC2944692]

PA Ho;TA Alonzo;KJ Kopecky;KL Miller;J Kuhn;R Gerbing;S Raimondi;B Hirsch;V Oehler;C Hurwitz;J Franklin;A Gamis;S Petersdorf;J Anderson;GH Reaman;LH Baker;C Willman;I Bernstein;G Radich;F Appelbaum;D Stirewalt;S Meshinchi Leukemia 24(5):909-913;

The effect of complete remission (CR) and CR with incomplete platelet recovery (CRp) on outcome in acute myeloid leukemia: a combined eastern cooperative oncology group (ECOG), Southwest Oncology Group (SWOG), and M.D. Anderson Cancer Center study

Journal of Clinical Oncology 28(10):1766-1771;

Prognostic impact of monosomal karyotype in young adults and elderly acute myeloid leukemia: the Southwest Oncology Group experience [PMID: 20562328; NIHMSID244631]

BC Medeiros;M Othus;M Fang;D Roulston;FR Appelbaum Blood 116(13):2224-2228

PMid: PMID20562328 | PMC number: PMC3709629

Over-expression of novel IRF8 splice variants is associated with a significant decrease in relapse-free survival in adult AML patients

E Porosova-Agadjanyan;K Kopecky;H Lee;J Anderson;J Godwin;A List;S Meshinchi;V Oehler;S Petersdorf;C Willman;F Appelbaum;JP Radich;D Stirewalt Blood 116:Abstract 1679; American Society of Hematology Annual Meeting; poster

Influence of residual normal metaphases in patients with monosomal karyotype

B Xie;M Othus;B Medeiros;M Fang;F Appelbaum;E Estey Blood 116:Abstract 1671; ASH 2010 meeting; poster presentation

2009

Very late antigen-4 (VLA-4) function of myeloblasts correlates with improved overall survival for patients with acute myeloid leukemia [PMC2630271; PMID18927435]

PS Becker;KJ Kopecky;AN Wilks;JM Harlan;CL Willman;SH Petersdorf;T Papayannopoulou;FR Appelbaum Blood 113(4):866-874

2007

Polymorphisms in DNA repair genes and therapeutic outcomes of AML patients from SWOG clinical trials [PMID17197435]

N Kuptsova;KJ Kopecky;J Godwin;J Anderson;A Hoque;CL Willman;ML Slovak;CB Ambrosone Blood 109(9):3936-3944

2006

Age and acute myeloid leukemia

FR Appelbaum;H Gundacker;DR Head;ML Slovak;CL Willman;JE Godwin;JE Anderson;SH Petersdorf Blood 107(9):3481-3485

Gene expression profiling of adult acute myeloid leukemia identifies novel biologic clusters for risk classification and outcome prediction.

CS Wilson;GS Davidson;SB Martin;E Andries;J Potter;R Harvey;K Ar;Y Xu;KJ Kopecky;DP Ankerst;H Gundacker;ML Slovak;M Mosquera-Caro;IM Chen;DL Stirewalt;M Murphy;FA Schultz;H Kang;X Wang;JP Radich;FR Appelbaum;SR Atlas;J Godwin;CL Willman Blood 108(2):685-696

Size of FLT3 internal tandem duplication has prognostic significance in patients with acute myeloid leukemia.

DL Stirewalt;KJ Kopecky;S Meshinchi;JH Engel;EL Pogosova-Agadjanyan;J Linsley;ML Slovak;CL Willman;JP Radich Blood 107(9):3724-3726

PMid: PMID16368883 | PMC number: PMC1895777

The clinical spectrum of adult acute myeloid leukaemia associated with core binding factor translocations.

FR Appelbaum;KJ Kopecky;MS Tallman;ML Slovak;HM Gundacker;HT Kim;GW Dewald;HM Kantarjian;SR Pierce;EH Estey British Journal of Haematology 135:165-173

Glutathione S-transferase (GSTM1, GSTT1 and GSTA1) polymorphisms and outcomes after treatment for acute myeloid leukemia: pharmacogenetics in Southwest Oncology Group (SWOG) clinical trials.

JR Weiss;KJ Kopecky;J Godwin;J Anderson;CL Willman;KB Moysich;ML Slovak;A Hoque;CB Ambrosone Leukemia 20:2169-2171

PMid: PMID17008887

2002

Outcome after induction chemotherapy for older patients with acute myeloid leukemia is not improved with mitoxantrone and etoposide compared to cytarabine and daunorubicin: a Southwest Oncology Group study

JE Anderson;KJ Kopecky;CL Willman;D Head;MR O'Donnell;FW Luthardt;TH Norwood;IM Chen;SP Balcerzak;DB Johnson;FR Appelbaum Blood 100(12):3869-3876

2001

The significance of trisomy 8 in myeloid leukemia: a Southwest Oncology Group (SWOG) study.

ML Slovak;H Gundacker;SR Wolman;FR Appelbaum American Journal of Human Genetics 69(4):232(#285)

2000

Acute myelogenous leukemia and aging. Clinical interactions.

JE Lancet;CL Willman;JM Bennett Hematology/Oncology Clinics of North America 14(1):251-267

1999

A randomized, phase III trial of mitoxantrone (M) + etoposide (E) versus daunomycin (D) + cytarabine (A) as induction therapy in pts over age 55 with previously untreated acute myeloid leukemia (AML): Southwest Oncology Group Study 9333

JE Anderson;KJ Kopecky;D Head;MR O'Donnell;FW Luthardt;TH Norwood;CL Willman;SP Balcerzak;DB Johnson;FR Appelbaum Blood 94(10)Suppl.1:383a(#1702)part_1_of_2

Other Clinical Trials

SWOG Clinical Trial Number
SWOG-148

Combination L-Asparaginase and Daunomycin Therapy of Adult Acute Leukemia

Research Committee(s)
Leukemia
Activated
02/08/1971
Closed
Phase
I
SWOG Clinical Trial Number
SWOG-7823/24/25/26

ROAP-AdOAP in Acute Adult Leukemia

Research Committee(s)
Leukemia
Activated
08/04/1978
Closed
09/10/1982
Closed
Phase
III
Published