SWOG clinical trial number
S1203

A Randomized Phase III Study of Standard Cytarabine Plus Daunomycin (7+3) Therapy versus Idarubicin with High Dose Cytarabine (IA) with or without Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML)

Closed
Phase
III
Accrual
96%
Abbreviated Title
PIII 7+3 vs IA vs IA+vorinostat for AML
Status Notes
S1203 will permanently close to accrual on 11/4/15 at 11:59pm Pacific Time.
Activated
12/15/2012
Closed
11/04/2015
Participants
NCORP, Members, Medical Oncologists, Pathologists, CTSU, Affiliates

Research committees

Leukemia

Treatment

Cytosine Arabinoside Daunomycin Idarubicin HCL Suberoylanilide Hydroxamic Acid (SAHA; Vorinostat)

Eligibility Criteria Expand/Collapse

-Morphologically confirmed newly diagnosed AML (by WHO criteria)
-APL, FAB, M3 or blastic transformation of CML NOT ELIGIBLE
-Pts with known CBF or FLT3 related leukemias are eligible, but should preferentially be placed on NCI-sponsored protocols specific for these subtypes, if available.
-Diagnostic/pre-treatment specimens obtained </= 28 days prior to reg submitted to local CLIA-approved laboratory for cytogenetic (and FISH if possible) analysis for risk status; karyograms and cytogenetics/FISH analysis reports must be submitted for discipline review
Must be chemo-naïve (no prior Induction chemo for AML or MDS; temp prior measures such as apheresis or hydroxyurea allowed)
-Prior anthracycline therapy is allowed (</=200 mg/m2 daunorubicin or equivalent)
-Pts with prior MDS must not have received azacitidine, decitabine, lenalidomide or vorinostat.
-Pts must have blood/ marrow aspirate obtained </=28 days prior to reg submitted for TM (with patient consent, residuals will be banked)
->/= 18 and </=60 years of age
-Zubrod PS </=3
-ECHO or MUGA with ejection fraction >/= 45% </=28 days prior to reg
-No prolonged QTc interval (> 500 msec) by EKG </= 28 days prior to reg
-No cardiac disease (NYHA > Class II); no unstable angina (symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months
-No coexisting medical condition that is likely to interfere with study procedures or results; must be reasonable candidates for intensive chemotherapy
-HIV+ pts must have following </=28 days prior to reg: CD4 cells ≥ 500/mm3; Viral load of < 50 copies HIV mRNA/mm3 if on cART or < 25,000 copies HIV mRNA if not on cART; No zidovudine or stavudine as part of cART
- Hepatitis B/C+ pts must have viral load < 800,000 IU/L </=28 days prior to reg
-Must be able to take oral meds
-Must not be pregnant or nursing; must agree to effective contraception
-Prior malignancy is allowed if it does not require concurrent therapy (Exception: Active hormonal therapy is allowed)
-Must not be receiving valproic acid.

Publication Information Expand/Collapse

2019

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

2018

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

Predicting Non-Fatal Toxicities with 7+3 Induction Chemotherapy in Adult Acute Myeloid Leukemia: Analysis of SWOG Trial S1203

M Othus;G Garcia-Manero;F Appelbaum;HP Erba;R Walter Blood 132:1403; American Society of Hematology Annual Meeting (Dec 1-4, 2018, San Diego, CA), poster

2017

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

SWOG S1203: A randomized phase III study of standard cytarabine plus daunorubicin (7+3) therapy versus idarubicin with high dose cytarabine (IA) with or without vorinostat (IA+V) in younger patients with previously untreated acute myeloid leukemia (AML)

G Garcia-Manero;M Othus;J Pagel;J Radich;M Fang;DA Rizzieri;G Marcucci;S Strickland;MR Litzow;ML Savoie;B Medeiros;M Sekeres;T Lin;G Uy;BL Powell;J Kolitz;R Larson;RM Stone;D Claxton;J Essell;S Luger;S Mohan;A Moseley;FR Appelbaum;H Erba Blood 128:901; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), oral

Feasibility of allogeneic hematopoietic cell transplantation among high-risk AML patients in first complete remission: results of the transplant objective from the SWOG (S1203) randomized phase III study of induction therapy using standard 7+3 therapy or idarubicin with high-dose cytarabine (IA) versus IA plus vorinostat

J Pagel;G Garcia-Manero;M Fang;J Radich;DA Rizzieri;G Marcucci;S Strickland;MR Litzow;ML Savoie;S Spellman;D Confer;J Chell;M Brown;B Medeiros;M Sekeres;TL Lin;G Uy;BL Powell;J Kolitz;RA Larson;RM Stone;D Claxton;J Essell;S Luger;S Mohan;A Moseley;H Erba;F Appelbaum Blood 128:1166; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), oral

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

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