SWOG clinical trial number
S0301

A Phase II Study of Induction With Daunorubicin, Cytarabine, and Cyclosporine All 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
Phase II Previously Untreated Non-M3 AML in Patients of Age 56 or Older
Activated
10/01/2003
Closed
12/15/2006
Participants
NCORP, Members, Medical Oncologists, Pathologists

Research committees

Leukemia

Treatment

Cytosine Arabinoside Cyclosporine Daunomycin Filgrastim GM-CSF

Eligibility Criteria Expand/Collapse

Initial Registration: Pts must have a morphologically confirmed diagnosis of AML with FAB classification other than M3, based on bone marrow and biopsy performed within 14 days prior to registration. Pts with M3 AML or blastic transformation of CML are not eligible. Pts must have reached their 56th birthday. Pts must have a Zubrod PS of 0-3 if less than age 61, Zubrod PS of 0-2 if age 61-70, and Zubrod PS of 0-1 if age 71 or older. Pts must have a bilirubin less than or equal to 2 x IULN, within 7 days prior to this registration, unless the elevation is due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis, and not to liver dysfunction. Pts must also have SGOT (AST) less than or equal to 4 x IULN, or SGPT (ALT) less than or equal to 4 x IULN, within 7 days prior to this registration. Serum creatinine less than or equal to 1.5 x IULN or a creatinine clearance greater than 40 cc/min, or both. Pts must have a normal left ventricular function with an ejection fraction greater than or equal to 50% as measured by MUGA scan or 2-D ECHO. Pts with unstable cardiac arrhythmias or unstable angina are not eligible. Pts must not have received prior systemic chemotherapy for acute leukemia. Administration of hydroxyurea to control high cell counts prior to registration is permitted. A history of prior treatment of MDS with low dose cytosine arabinoside or with azacitidine is permitted; however, 30 days must have elapsed from prior treatment and all toxicities resolved. If indicated, a single dose of intrathecal chemotherapy may also be given before or concurrent with induction chemotherapy. Pts must be registered on SWOG-9007 and on S9910. Pts must agree to submit blood and plasma for PK studies per the protocol. Pts must not be pregnant or nursing. Women/men 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 years.

Publication Information Expand/Collapse

2018

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

2016

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

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

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

2013

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;

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

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;

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;