SWOG clinical trial number
S0106

A Phase III Study of the Addition of Gemtuzumab Ozogamicin (Mylotarg�) Induction Therapy Versus Standard Induction With Daunomycin and Cytosine Arabinoside Followed by Consolidation and Subsequent Randomization to Post-Consolidation Therapy With Gemtuzumab Ozogamicin (Mylotarg�) or No Additional Therapy for Patients Under Age 61 With Previously Untreated De Novo Acute Myeloid Leukemia (AML)

Closed
Phase
Accrual
93%
Published
Abbreviated Title
Phase III Starndard + Mylotarg vs. Standard + Daunomycin/Ara-C for AML Under Age 61
Activated
05/15/2004
Closed
08/20/2009
Participants
NCORP, Members, Medical Oncologists, Pathologists, CTSU

Research committees

Leukemia

Treatment

Cytosine Arabinoside Daunomycin Gemtuzumab Ozogamicin rhGM-CSF G-CSF

Eligibility Criteria Expand/Collapse

Pts must have a morphologically confirmed diagnosis of AML with FAB classification other than M3, based on bone marrow aspiration and biopsy performed within 14 days prior to registration. Pts with M3 AML or blastic transformation of CML are not eligible. Pts with preexisting hematologic disorder evolving to AML such as myelodysplasia or secondary leukemia are not eligible. Pts must have reached their 18th birthday but not reached their 61st birthday. Zubrod PS of 0-3. Pt must have a bilirubin less than or equal to 2 x IULN. Pt must also have SGOT (AST) less than or equal to 3 x IULN and SGPT (ALT) less than or equal to 3 x IULN. Studies must be performed within 14 days prior to registration. Pts must have a normal left ventricular function with an ejection fraction less than or equal to 50% as measured by MUGA scan or 2-D ECHO within 42 days prior to registration. Pts with unstable cardiac arrhythmias or unstable angina are not eligible. Pts must not have received systemic chemotherapy or more than one dose of intrathecal chemotherapy for acute leukemia. Administration of hydroxyurea to control high cell counts prior to registration is permitted. Pretreatment pathology materials must be submitted for morphologic review as per the protocol. Pts must participate in cytogenetics studies as detailed in Section 5.1h. Collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration. SWOG pts (and other pts not affiliated with CALGB or NCIC) must be registered on protocol S9910, "Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary." Collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration. CALGB pts are encouraged to register to C9665. NCIC pts are encouraged to register to S9910. Specimens collected within 14 days prior to reg must be submitted for studies of FLT3 and flow cytometric MRD detection. Pts must not be pregnant or nursing. Pts of reproductive potential must have agreed to use an effective contraceptive method. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the pt is currently in complete remission, or any other cancer from which the pt has been disease-free for 5 yrs. Pts who have known liver disease or known Hepatitis B(HbsAg positive) or active Hepatitis C infection are not eligible. If viral status is not known, pts are eligible for study.

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

Improved outcomes with 7+3 induction chemotherapy for acute myeloid leukemia over the past four decades: Analysis of SWOG trial data

M Othus;G Garcia-Manero;J Godwin;J Weick;F Appelbaum;H Erba;E Estey Haematologica Jan 1;108(1):42-47

PMid: PMID35833298 | PMC number: PMC9827148

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

Quantification of measurable residual disease using duplex sequencing in adults with acute myeloid leukemia.

L Dillon;J Higgins;H Nasif;M Othus;L Beppu;T Smith;E Schmidt;C Valentine;J Salk;B Wood;J Radich;C Hourigan Haematologica Aug 3; doi: 10.3324/haematol.2023.283520 Online ahead of print

PMid: PMID:37534515 | PMC number: PMC10081409

Whole Genome Sequencing Informed Patient Personalized Measurable Residual Disease Assays for Acute Myeloid Leukemia (SWOG S0106)

N Ravindra;L Dillon;J Lack;C Dalgard;E vanCollenburg;A Corner;L Beppu;H Erba;M Othus;J Radich;C Hourigan Journal of Molecular Diagnotics Volume 25;Issue 11, SupplementS1-S186; Association for Molecular Pathology (AMP) 2023 Conference (Nov 14-18, 2023, Salt Lake City, UT), poster

Characteristics and prognostic impact of IDH mutations in AML: a COG, SWOG, ECOG analysis

S Zarnegar-Lumley;T Alonzo;R Gerbing;M Othus;Z Sun;R Ries;J Wang;A Leonti;M Kutny;F Ostronoff;J Radich;F Appelbaum;E Pogosova-Agadjanyan;K O'Dwyer;M Tallman;M Litzow;E Atallah;T Cooper;R Aplenc;O Abdel-Wahab;A Gamis;S Luger;H Erba;R Levine;E Kolb;D Stirewalt;S Meshinchi;K Tarlock Blood Adv. Oct 10;7(19):5941-5953

PMid: PMID37267439 | PMC number: PMC10562769

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

2021

Associations Between Complete Remission and 2-3 Year Survival Following 7+3 Induction for Acute Myeloid Leukemia

M Othus;G Garcia-Manero;J Godwin;J Weick;D Stirewalt;F Appelbaum;H Erba;E Estey Leukemia & Lymphoma, Aug;62(8):1967-1972; Mar 10;1-6. doi: 10.1080/10428194.2021.1885663. Online ahead of print.2021

PMid: PMID3719833

Predicting Severe Toxicities with Intensive Induction Chemotherapy for Adult Acute Myeloid Leukemia: Analysis of SWOG Trials S0106 and S1203

A Moseley;M Othus;G Garcia-Manero;F Appelbaum;H Erba;R Walter Leukemia and Lymphoma Jul;62(7):1774-1777

PMid: PMID33560164 | PMC number: PMC8282671

Proteogenomic Characterization of Highly Enriched Viable Leukemic Blasts in Acute Myeloid Leukemia: A SWOG Report

J Naru;M Othus;C Lin;A Moseley;A List;C Willman;E Pogosova-Agadjanyan;F Wu;F Appelbaum;H Erba;I-M Chen;I Jenkins;J Kennedy;J Delrow;J Whiteaker;J Radich;J Godwin;L Beppu;M Fitzbiggon;M Fang;P Wang;P Gafken;R Ivey;S Meshinchi;T Chauncey;T Lorentzen;U Voytovich;A Paulovich;D Stirewalt American Society of Hematology (Dec 11-14, 2021, Atlanta, GA), oral, #522

Global Proteomic Profiling Identifies Novel Prognostic Biomarkers in Undifferentiated Leukemia Blasts from Patients with NPM1 Mutations: A First-Of-Its-Kind Report Form the Fred Hutch and SWOG

D Stirewalt;M Othus;Y Naru;J Kennedy;E Pogosova-Agadjanyan;F Appelbaum;L Beppu;T Chauncey;J Delrow;H Erba;P Gafken;J Godwin;M Fitzgibbons;X Hua;I Jenkins;M Fang;R Ivey;C Lin;T Lorentzen;A Moseley;J Radich;J Voytovich;P Wang;J Whiteaker;C Willman;F Wu;S Meshinchi;A Paulovich American Society of Hematology (Dec 11-14, 2021, Atlanta, GA), oral, #799

Duplex Sequencing for Ultra-Low Frequency Measurable Residual Disease Detection in Adult Acute Myeloid Leukemia

J Higgins;M Othus;L Dillon;T Smith;E Schmidt;J Yaplee;F Lo;C Valentine;J Salk;C Hourigan;J Radich American Society of Hematology (Dec 11-14, 2021, Atlanta, GA), poster, #3457

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

Bias in mean survival from fitting cure models with limited follow-up

M Othus;A Bansal;H Erba;S Ramsey Value in Health Aug;23(8):1034-1039

PMid: PMID32828215 | PMC number: PMC7446760

Characteristics and Prognostic Effects of IDH Mutations across the Age Spectrum in AML: A Collaborative Analysis from COG, SWOG, and ECOG

S Zarnegar-Lumley;T Alonzo;M Othus;Z Sun;R Ries;Y Wang;A Leonti;M Kutney;D Stirewalt;J Radich;F Appelbaum;E Pogosova-Agadjanyan;K O'Dwyer;H Erba;O Abdel-Wahab;M Tallman;M Litzow;E Atallah;S Luger;R Levine;T Cooper;A Gamis;R Aplenc;A Kolb;S Meshinchi;K Tarlock American Society of Hematology (December 5-8, 2020, San Diego, CA), oral, abst #388

2019

The relationship between clinical trial accrual volume and outcomes in acute myeloid leukemia: A SWOG/ ECOG-ACRIN Study (S0106 and E1900)

B Medeiros;M Othus;MS Tallman;Z Sun;HF Fernandez;JM Rowe;HM Lazarus;F Appelbaum;SM Luger;MR Litzow;H Erba Leukemia Research Mar;78:29-33

PMid: PMID30673620 | PMC number: PMC6615032

Second Cycle Remission Achievement with 7+3 and Survival in Adults with Newly Diagnosed Acute Myeloid Leukemia: Analysis of Recent SWOG Trials

M Othus;E Estey;G Garcia-Manero;BL Wood;D Stirewalt;J Godwin;J Weick;J Anderson;F Appelbaum;H Erba;R Walter Leukemia Feb;33(2):554-558; Oct 12. doi: 10.1038/s41375-018-0274-y. [Epub ahead of print]

PMid: PMID30315233 | PMC number: PMC6367002

Relative survival following response to 7+3 versus azacytidine is similar in acute myeloid leukemia and high-risk myelodysplastic syndromes: An analysis of four SWOG studies

M Othus;M Sekeres;S Nand;G Garcia-Manero;F Appelbaum;HP Erba;E Estey Leukemia Feb;33(2):371-378; Oct 12. doi: 10.1038/s41375-018-0275-x. [Epub ahead of print]

PMid: PMID30315234 | PMC number: PMC6367029

Karyotype gender mismatch: a novel method of identifying transgender patients in large cohorts of patients with leukemia

A Alpert;M Othus;H Erba;K O'Dwyer Acute Leukemia Forum (April 11- 12, 2019, Newport Beach, accepted poster

Increasing lengths of first complete remission with 7+3 induction chemotherapy for acute myeloid leukemia over the past four decades: Analysis of SWOG trial data

M Othus;G Garcia-Manero;JE Godwin;JK Weick;F Appelbaum;H Erba;E Estey Blood (2019) 134 (Supplement_1): 291, abst 613 (American Society of Hematology Annual Meeting (Dec 7-10, 2019, Orlando, FL), oral

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

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

Comparable Outcomes of Patients Eligible versus Ineligible for SWOG Leukemia Studies

A Statler;M Othus;H Erba;T Chauncey;J Radich;S Coutre;A Advani;S Nand;F Ravandi;S Mukherjee;M Sekeres Blood Jun 21;131(25):2782-2788; Apr 4 [Epub ahead of print]

PMid: PMID29618479 | PMC number: PMC6014358

Phase 1/2 Trial of GCLAM with Dose-Escalated Mitoxantrone for Newly Diagnosed AML or Other High-Grade Myeloid Neoplasms

A Halpern;M Othus;E Huebner;BL Scott;P Becker;M Percival;P Hendrie;KM Gardner;TL Chen;S Buckley;KF Orlowski;A Anwar;F Appelbaum;H Erba;E Estey;R Walter Leukemia Nov;32(11):2352-2362; Apr 17 [Epub ahead of print]

PMid: PMID29720734 | PMC number: PMC6192860

2nd Cycle Remission Achievement with 7+3 is Associated with Shorter Survival in Adults with Newly Diagnosed Acute Myeloid Leukemia: Analysis of Recent SWOG Trials

M Othus;E Estey;G Garcia-Manero;B Wood;DL Stirewalt;J Godwin;J Weick;J Anderson;F Appelbaum;H Erba;R Walter Blood 132:3978; American Society of Hematology Annual Meeting (Dec 1-4, 2018, San Diego, CA), poster

Event-free Survival as a Surrogate Endpoint for Overall Survival in Previously Untreated Acute Myeloid Leukemia: An Individual Patient-level Analysis of Multiple Randomized Trials (Alliance A151614)

J Yin;B Laplant;E Storrick;J Uy;G Marcucci;H Fernandez;X Sun;S Petersdorf;F Appelbaum;M Othus;RA Larson;S Stone Blood 132:1386; American Society of Hematology Annual Meeting (Dec 1-4, 2018, San Diego, CA), accepted, poster

Value of Anti-Cancer Drugs in SWOG Phase III Clinical Trials: Evidence from Multiple Evaluation Mechanisms

V Nghiem;R Vaidya;M Banegas;D Hershman;J Unger AcademyHealth Annual Research Meeting (June 23-26, 2018, Seattle, WA), poster #B-335

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

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

End points and statistical considerations in immuno-oncology trials: impact on multiple myeloma.

A Hoering;BGM Durie;H Wang;J Crowley Future Oncology Jun;13(13):1181-1193

PMid: PMID28395525 | PMC number: PMC5705823

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

Relation between event-free survival and overall survival in acute myeloid leukemia: A report from SWOG, HOVN/SAKK, and MRC/NCRI

M Othus;W van Putten;B Lowenberg;S Petersdorf;S Nand;H Erba;F Appelbaum;R Hills;N Russell;A Burnett;E Estey Haematologica Jul;101(7):e284-286; 2016 Mar 24 [Epub ahead of print]

PMid: PMID27013652 | PMC number: PMC5004473

Effect of measurable ("minimal") residual disease (MRD) information on prediction of relapse and survival in adult acute myeloid leukemia

M Othus;B Wood;D Stirewalt;E Estey;S Petersdorf;F Appelbaum;H Erba;R Walter Leukemia Oct;30(10):2080-2083; 2016 May 2 [Epub ahead of print]

PMid: PMID27133827 | PMC number: PMC5053842

A Phase 1/2 Study of G-CSF, cladribine, cytarabine, and dose-escalated mitoxantrone (G-CLAM) in adults with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS): final results from a phase 1/2 study

A Halpern;E Estey;EM Huebner;M Othus;KF Orlowski;BL Scott;HA Smith;PS Becker;M-B M Percival;PC Hendrie;AM Perdue;T Chen;S Buckley;H Erba;R Walter Blood 128:1068; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), oral

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

Complete remissions (CRs) with azacitidine regimens compared to CRs with 7+3 induction chemotherapy and the effect on overall survival

M Othus;M Sekeres;S Nand;G Garcia-Manero;F Appelbaum;H Erba;E Estey Blood 128:1613; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), poster

Comparable outcomes of patients eligible versus ineligible for SWOG leukemia studies

A Statler;M Othus;H Erba;T Chauncey;J Radich;S Coutre;A Advani;S Nand;F Ravandi;S Mukherjee;M Sekeres Blood 128:4002; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), poster

Genomic subtypes of nucleophosmin (NPM1) mutations are associated with clinical outcome in AML – A COG and SWOG intergroup collaboration

D Selim;T Alonzo;M Othus;R Gerbing;F Ostronoff;K Tarlock;E Kutny;R Aplenc;A Kolb;J Radich;F Appelbaum;A Gamis;D Stirewalt;S Meshinchi Blood 128:285; American Society of Hematology Annual Meeting (December 3-6, 2016,San Diego, CA), oral

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

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

The fate of patients with newly diagnosed acute myeloid leukemia who fail primary induction therapy

M Othus;F Appelbaum;S Petersdorf;K Kopecky;M Slovak;T Nevill;J Brandwein;RA Larson;R Walter;M Tallman;L Stenke;H Erba Biology of Blood and Marrow Transplantation Mar;21(3):559-564

PMid: PMID25536215 | PMC number: PMC4386840

Phase 1 Trial of G-CSF, cladribine, cytarabine, and dose-escalated mitoxantrone (G-CLAM) in adults with newly diagnosed AML or high-risk MDS

A Anwar;A Halpern;BL Scott;PS Becker;M Othus;PC Hendrie;EM Ranker;A Perdue;TL Chen;SA Buckley;KF Orlowski;MA Powell;E Estey;RB Walter European Hematology Association Annual Meeting (June 11-14, 2015, Vienna, Austria), poster;

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

Empiric definition of eligibility criteria for clinical trials in relapsed/refractory acute myeloid leukemia: analysis of 1,892 patients from HOVON/SAKK and SWOG

R Walter;M Othus;B Lowenberg;G Ossenkoppele;S Petersdorf;T Pabst;M-C Vekemans;F Appelbaum;H Erba;E Estey Haematologica Oct;100(10):e409-11

PMid: PMID26160876 | PMC number: PMC4591777

Effect of minimal residual disease (MRD) information on prediction of relapse and survival in adult acute myeloid leukemia (SWOG S0106)

M Othus;B Wood;E Estey;S Petersdorf;F Appelbaum;H Erba;R Walter Blood 126(23):2569; American Society of Hematology Annual Meeting (Dec 5-8, 2015, Orlando, FL), poster;

Defining the genomic make up of acute myeloid leukemia in adolescents and young Adults (AYA) – report from COG AAML03P1, AAML531 and SWOG S0106

F Ostronoff;TA Alonzo;M Othus;M Kutny;RB Gerbing;JP Radich;H Erba;F Appelbaum;AS Gamis;EA Kolb;D Stirewalt;S Meshinchi Blood 126(23):2576; American Society of Hematology Annual Meeting (Dec 5-8, 2015, Orlando, FL), poster;

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

Addition of gemtuzumab ozogamicin to induction chemotherapy improves survival in acute myeloid leukaemia by reducing relapse risk: A source data meta-analysis of randomised trials in adults

R Hills;S Castaigne;F Appelbaum;J Delaunay;S Petersdorf;M Othus;E Estey;H Dombret;S Chevret;N Ifrah;J-Y Cahn;C Recher;L Chilton;A Moorman;A Burnett Lancet Oncology 15(9):986-996

PMid: PMID25008258 | PMC number: PMC4137593

NUP98/NSD1 and FLT3/ITD coexpression is more prevalent in younger AML patients and leads to induction failure: a COG and SWOG report

F Ostronoff;M Othus;RB Gerbing;MR Loken;SC Raimondi;BA Hirsch;BJ Lange;S Petersdorf;J Radich;F Appelbaum;AS Gamis;T Alonzo;S Meshinchi Blood 124(15):2400-2407;

PMid: PMID25145343 | PMC number: PMC4192751

Empiric definition of eligibility criteria for clinical trials in relapsed/refractory AML: analysis of 1,892 patients from HOVON/SAKK and SWOG

R Walter;M Othus;B Lowenberg;G Ossenkoppele;S Petersdorf;T Pabst;MC Vekemans;F Appelbaum;H Erba;E Estey Blood 124(21):3676; American Society for Hematology (December 6-9, 2014, San Francisco, CA), poster;

2013

Outcome of adolescents and young adults with acute myeloid leukemia treated on COG trials compared to CALGB and SWOG trials

WG Woods;AR Franklin;TA Alonzo;RB Gerbing;KA Donohue;M Othus;J Horan;FR Appelbaum;EH Estey;CD Bloomfield;RA Larson Cancer 119(23):4170-4179;

PMid: PMID24104597 | PMC number: PMC3833872

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 phase III study of of gemtuzumab ozogamicin during induction and post-consolidation therapy in younger patients with acute myeloid leukemia (AML): SWOG intergroup trial S0106

S Petersdorf;K Kopecky;M Slovak;C Willman;T Nevill;J Brandwein;RA Larson;H Erba;P Stiff;RK Stuart;M Tallman;L Stenke;F Appelbaum Blood 121(24):4854-4860;

PMid: PMID23591789 | PMC number: PMC3682338

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

Evaluation of which patients get a second course of 3+7 on cooperative group trials for newly diagnosed acute myeloid leukemia: a report from SWOG

M Othus;F Appelbaum;S Petersdorf;HP Erba;E Estey Blood 122:3925; American Society of Hematology annual meeting (Dec 7-10, 2013, New Orleans, LA), poster;

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;

The addition of gemtuzumab ozogamicin (GO) to induction chemotherapy reduces relapse and improves survival in patients without adverse risk karyotype: results of an individual patient meta-analysis of the five randomised trials

R Hills;S Petersdorf;E Estey;M Othus;F Appelbaum;S Castaigne;H Dombret;S Chevert;J Delaunay;N Ifrah;J-Y Chan;C Recher;AK Burnett Blood 122:356, 2013; American Society of Hematology annual meeting (Dec 7-10, 2013, New Orleans, LA), oral;

PMid: n/a | PMC number: n/a

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;

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;

NUP98/NSD1 translocation further risk-stratifies patients with FLT3/ITD in acute myeloid leukemia: A report from Children’s Oncology Group and SWOG

F Ostronoff;M Othus;RB Gerbing;MR Loken;S Raimondi;B Hirsch;BJ Lange;S Petersdorf;J Radich;F Appelbaum;AS Gamis;TA Alonzo;S Meshinchi Blood 122:488; American Society of Hematology annual meeting (Dec 7-10, 2013, New Orleans, LA), oral;

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;

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 significance of FLT3 and NPM1 mutations in adults of age 18-60 with de novo acute myeloid leukemia (AML): a study by FHCRC and SWOG

EL Pogosova-Agadjanyan;K Kopecky;S Petersdorf;H Erba;RM Stone;S Mehinchi;TJ Nevill;J Radich;L Stenke;M Slovak;RK Stuart;M Tallman;C Willman;A Brumbaugh;M Cronk;C Cummings;J Engel;R Mortensen;A Suchanek;F Appelbaum;D Stirewalt Blood 118(21):abst 2520; American Society of Hematology Annual Meeting, 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;

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

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

Outcome of adolescents and young adults (AYAs) with non-M3 acute myeloid leukemia (AML) treated on Children's Oncology Group (COG) trials compared to Cancer and Leukemia Group B (CALGB) and Southwest Oncology Group (SWOG) trials

A Franklin;T Alonzo;RB Gerbing;K Donohue;M Othus;J Horan;E Estey;RA Larson;WG Woods Blood 116:Abstract 183; 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

Preliminary results of Southwest Oncology Group study S0106: an international intergroup phase 3 randomized trial comparing the addition of gemtuzumab ozogamicin to standard induction therapy versus standard induction therapy followed by a second randomization to no additional therapy versus post-consolidation gemtuzumab ozogamicin for previously untreated acute myeloid leukemia

SH Petersdorf;KJ Kopecky;RK Stuart;TJ Nevill;R Larson;L Stenke;M Tallman;M Slovak;C Willman;H Erba;F Appelbaum Blood 114:abst. #790

Other Clinical Trials

SWOG Clinical Trial Number
CTSU/A042001

A Randomized Phase II Study Comparing Inotuzumab Plus Chemotherapy Versus Standard Chemotherapy in Older Adults with Philadelphia-Chromosome-Negative B-Cell Acute Lymphoblastic Leukemia
Research Committee(s)
Leukemia
Activated
02/27/2023
Open
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SWOG Clinical Trial Number
S1925

A Randomized, Phase III Study of Early Intervention with Venetoclax and Obinutuzumab versus Delayed Therapy with Venetoclax and Obinutuzumab in Newly Diagnosed Asymptomatic High-Risk Patients with Chronic Lymphocytic Leukemia (CLL): EVOLVE CLL Study.
Research Committee(s)
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Lymphoma
Symptom Control and Quality of Life
Activated
12/14/2020
Accrual
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Open
Phase
SWOG Clinical Trial Number
CTSU/AALL1821

A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination with Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old with First Relapse
Research Committee(s)
Leukemia
Activated
12/04/2020
Open