SWOG clinical trial number
S0535

A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients With Previously Untreated High-Risk Acute Promyelocytic Leukemia

Closed
Phase
Accrual
100%
Abbreviated Title
Phase II ATRA, Arsenic and Mylotarg for Untreated High-Risk APL
Activated
11/15/2007
Participants
NCORP, Members, Medical Oncologists, Pathologists, CTSU, Affiliates

Research committees

Leukemia

Treatment

6-Mercaptopurine All trans retinoic acid Daunomycin Methotrexate Arsenic Trioxide Gemtuzumab Ozogamicin

Eligibility Criteria Expand/Collapse

Morphologically confirmed diagnosis of high risk APL based on BM done within 14 days before reg. WBC confirming high risk must be done within 14 days before reg. Pts known to be PML-RARalpha negative by RT-PCR results are not eligible. 18 years of age or older. QTc </= 0.47 sec. Must not have received systemic chemo for acute leukemia. Hydroxyurea, corticosteroids or leukapheresis to control high cell count permitted. Up to 3 days ATRA permitted. SWOG pts must have local cytogenetics and must submit specimens for RT-PCR testing to a CLIA-approved laboratory; ECOG and CALGB pts must submit specimens as outlined. Pts must not be pregnant or nursing. No other prior malignancy except 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 years.

Publication Information Expand/Collapse

2020

A Phase II Study of ATRA, Arsenic Trioxide and Gemtuzumab Ozogamicin in Patients with Previously Untreated High-Risk Acute Promyelocytic Leukemia (SWOG S0535)

JE Lancet;AB Moseley;SE Coutre;DJ DeAngelo;M Othus;MS Tallman;MR Litzow;RS Komrokj;HP Erba;FR Appelbaum Blood Advances Apr 28;4(8):1683-1689

PMid: PMID32330241 | PMC number: PMC7189292

2017

Mutations in Acute Promyelocytic Leukemia are Similar at Diagnosis and Relapse and ETV6 may be a Molecular Biomarker of Decreased Disease Free Survival and High Risk Disease Independent of White Blood Count

E Stein;A Viny;S Devlin;E Paietta;F Appelbaum;J Lancet;R Larson;B Powell;P Wiernik;R Levine;M Tallman International Symposium on Acute Promyelocytic Leukemia (September 24-27, 2017, Rome, Italy), oral presentation

2016

ATRA, arsenic trioxide (ATO), and gemtuzumab ozogamicin (GO) is safe and highly effective in patients with previously untreated high-risk acute promyelocytic leukemia (APL): final results of the SWOG/Alliance/ECOG S0535 trial

JE Lancet;A Moseley;R Komrokji;S Coutre;D DeAngelo;M Tallman;M Litzow;M Othus;F Appelbaum Blood 128:896; American Society of Hematology Annual Meeting(December 3-6, 2016, San Diego, CA), oral

2015

Safety and tolerability of the combination of ATRA + Arsenic Trioxide (ATO) + Gemtuzumab Ozogamicin (GO) in high-risk acute promyelocytic leukemia (APL): initial report of the SWOG/Alliance/ECOG S0535 trial (NCT00551460)

J Lancet;M Othus;R Komrokji;S Coutre;D DeAngelo;M Tallman;M Litzow;F Appelbaum Journal of Clinical Oncology 33:5s (suppl; abstr 7016); American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), poster discussion;

2013

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;

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