SWOG clinical trial number
S0112

S0112, A Phase II Study Of Daunomycin And Ara-C, Both Given By Continuous IV Infusion For Previously Untreated Non-M3 Acute Myeloid Leukemia (AML) In Patients Of Age 56 Or Older.

Closed
Phase
Accrual
100%
Published
Abbreviated Title
Elderly AML
Activated
08/01/2001
Closed
04/01/2003
Participants
NCORP, Members, Medical Oncologists, Pathologists

Research committees

Leukemia

Treatment

Cytosine Arabinoside Daunomycin Filgrastim GM-CSF

Eligibility Criteria Expand/Collapse

Must have morphologically confirmed diagnosis of AML with FAB class other than M3, based on bone marrow aspiration and biopsy performed within 14 days prior to registration. Patients with marked leukocytosis may be registered prior to the availability of biopsy results if the absolute blast count is >= 100,000 cells/µl; Patients must be >/=56 years old, Zubrod PS 0-3; no prior systemic chemotherapy for AML (hydroxyurea to control high cell counts prior to registration is permitted). A history of prior treatment of MDS with low dose cytosine arabinoside (i.e., < 100 mg/M2/day) is permitted; however, 30 days must have elapsed from prior treatment and all toxicities resolved. Patients must have adequate renal, liver, and cardiac function as outlined in protocol.

Publication Information Expand/Collapse

2023

Verification of prognostic expression biomarkers is improved by examining enriched leukemic blasts rather than mononuclear cells from acute myeloid leukemia patients

E Pogosova-Agadjanyan;X Hua;M Othus;F Appelbaum;T Chauncey;H Erba;M Fitzgibbon;J Godwin;I Jenkins;M Fang;A Moseley;J Naru;J Radich;B Willborg;C Willman;F Wu;S Meshichi;D Stirewalt Biomarker Research Mar 16;11(1):31. doi: 10.1186/s40364-023-00461-0

PMid: PMID36927800 | PMC number: PMC10022072

Long Non-coding RNA Expression Independently Predicts Outcome in Pediatric Acute Myeloid Leukemia

J Farrar;J Smith;M Othus;B Huang;Y Wang;R Ries;T Hylkema;E Pogosova-Agadjanyan;A Leonti;T Shaw;T Triche;A Gamis;R Aplenc;E Kolb;X Ma;D Stirewalt;T Alonzo;S Meshinchi Journal of Clinical Oncology Jun 1;41(16):2949-2962

PMid: PMID36795987 | PMC number: PMC10414715

Examining the impact of age on the prognostic value of ELN-2017 and ELN-2022 AML risk stratifications: A SWOG report

C Termini;A Moseley;M Othus;F Appelbaum;T Chauncey;H Erba;M Fang;S Lee;J Naru;E Pogosova- Agadjanyan;J Radich;C Willman;F Wu;S Meshinchi;D Stirewalt Haematologica. Apr 6. doi: 10.3324/haematol.2023.282733. Online ahead of print

PMid: PMID37021537 | PMC number: PMC Journal - In Process

2022

A Robust Long Non-Coding RNA Expression Classifier for Risk Stratification in Pediatric AML

J Farrar;J Smith;M Othus;B Huang;Y Wang;R Ries;T Hylkema;E Pogosova-Agadjanyan;A Leonti;T Shaw;T Triche;A Gamis;R Aplenc;E Kolb;X Ma;D Stirewalt;T Alonzo;S Meshinchi ASH Annual Meeting (Dec 10 thru 13, 2022, New Orleans, LA), poster

2020

AML Risk Stratification Models Utilizing ELN-2017 Guidelines and Additional Prognostic Factors: A SWOG Report

E Pogosova-Agadjanyan;A Moseley;M Othus;F Appelbaum;T Chauncey;I-M Chen;HP Erba;JE Godwin;I Jenkins;M Fang;M Huyhn;K Kopecky;A List;J Naru;G Pogosov;J Radich;E Stevens;B Willborg;C Willman;BL Wood;Q Zhang;S Meshinchi;D Stirewalt Biomarker Research Aug 12;8:29

PMid: PMID32817791 | PMC number: PMC7425159

2019

Development and Performance of Risk Stratification Models for AML Patients Utilizing ELN-2017 Guidelines and Additional Prognostic Factors: A SWOG Report

E Pogosova-Agadjanyan;A Moseley;F Appelbaum;T Chauncey;I-M Chen;H Erba;J Godwin;I Jenkins;M Fang;M Huynh;K Kopecky;A List;J Naru;J Radich;E Stevens;B Willborg;C Willman;B Wood;Q Zhang;S Meshinchi;D Stirewalt Blood (2019) 134 (Supplement_1): 2691; American Society of Hematology Annual Meeting (Dec 7-10, 2019, Orlando, FL), poster

2018

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

2017

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

2016

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

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

2013

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

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 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;

Alteration of cytogenetic risk stratification in new diagnosis of leukemia by FISH testing - the SWOG experience

M Fang;S McDonough;M Othus;L Zhuo;D Roulston;H Erba;F Appelbaum Blood 122:1383; American Society of Hematology annual meeting (Dec 7-10, 2013, New Orleans, LA), poster;

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

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

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

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;

2010

Sequential phase II Southwest Oncology Group studies (S0112 and S0301) of daunorubicin and cytarabine by continuous infusion, without and with cyclosporine, in older patients with previously untreated acute myeloid leukemia (AML) [PMID 19821823; PMC2967366]

TR Chauncey;H Gundacker;M Shadman;AF List;SR Dakhil;HP Erba;ML Slovak;I-M Chen;CL Willman;K Kopecky;FR Appelbaum British Journal of Haematology 148(1):48-58;

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

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

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