Daunorubicin and Cytarabine with or without Uproleselan in Treating Older Adult Patients with Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Status: Active

Description

This phase II / III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of acute myeloid leukemia (AML) based on 2017 World Health Organization (WHO) criteria excluding acute promyelocytic leukemia with PML-RARA. * Note: Patients with myeloid sarcoma without bone marrow involvement, acute leukemia of ambiguous lineage or blast transformation of chronic myelogenous leukemia (CML) are not eligible.
  • No activating mutation in the Fms-like tyrosine kinase-3 (FLT3) defined as a ratio of mutant to wild-type allele >= 0.05 by capillary electrophoresis or a variant allele fraction of >= 5% by next generation sequencing from either bone marrow or peripheral blood.
  • No evidence of CNS involvement of AML.
  • No prior chemotherapy for myelodysplastic syndrome (MDS) or AML including hypomethylating agents (e.g. azacitidine and decitabine) or lenalidomide with the following exceptions: * Emergency leukapheresis. * Hydroxyurea. * Growth factor/cytokine support. * All-trans retinoic acid (ATRA). * Single dose of intrathecal cytarabine and/or methotrexate for patients undergoing lumbar puncture to evaluate for CNS involvement.
  • Total bilirubin =< 3 x upper limit of normal (ULN)
  • Creatinine < 3 x upper limit of normal (ULN) OR creatinine clearance >= 30 mL/min/1.73m^2

Locations & Contacts

Arkansas

Little Rock
University of Arkansas for Medical Sciences
Status: Active
Contact: Site Public Contact
Phone: 501-686-8274

California

Clovis
Community Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 559-387-1827
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 858-822-5354
Email: cancercto@ucsd.edu

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Delaware Clinical and Laboratory Physicians PA
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Helen F Graham Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org
Medical Oncology Hematology Consultants PA
Status: Active
Contact: Site Public Contact
Phone: 302-623-4450
Email: KDempsey@christianacare.org

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact
Phone: 208-381-2774
Email: eslinget@slhs.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Kootenai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Emmett
Walter Knox Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Meridian
Idaho Urologic Institute-Meridian
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Nampa
Saint Alphonsus Medical Center-Nampa
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Post Falls
Kootenai Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Carbondale
Memorial Hospital of Carbondale
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 618-457-5200
Email: clinical.research@sih.net
Carterville
SIH Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 618-985-3333
Email: clinical.research@sih.net
Carthage
Illinois CancerCare-Carthage
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Centralia
Centralia Oncology Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Chicago
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
University of Chicago Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
University of Illinois
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Decatur Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Effingham
Crossroads Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Eureka
Illinois CancerCare-Eureka
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Western Illinois Cancer Treatment Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-344-2831
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Macomb
Illinois CancerCare-Macomb
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
New Lenox
UC Comprehensive Cancer Center at Silver Cross
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Orland Park
University of Chicago Medicine-Orland Park
Status: Active
Contact: Site Public Contact
Phone: 773-702-8222
Email: cancerclinicaltrials@bsd.uchicago.edu
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Pekin
Illinois CancerCare-Pekin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Methodist Medical Center of Illinois
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Valley Radiation Oncology
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 815-664-4141
Princeton
Illinois CancerCare-Princeton
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 309-243-3605
Email: andersonj@illinoiscancercare.com
Springfield
Memorial Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-788-3528
Southern Illinois University School of Medicine
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-545-7929
Springfield Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-444-7541
Swansea
Cancer Care Specialists of Illinois-Swansea
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 217-876-4740
Email: rhamrick@dmhhs.org
Southwest Illinois Health Services LLP
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 618-236-1000
Email: lynns@thecancercenter.com

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 317-278-5632
Email: iutrials@iu.edu

Iowa

Ames
Mary Greeley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: Active
Contact: Site Public Contact
Phone: 515-239-4734
Email: ksoder@mcfarlandclinic.com
Boone
McFarland Clinic PC-Boone
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Iowa City
University of Iowa / Holden Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-237-1225
Jefferson
McFarland Clinic PC-Jefferson
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Sioux City
Siouxland Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 712-252-9326
Email: HoopingarnerT@jencc.com

Kansas

Kansas City
University of Kansas Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 913-945-7552
Email: ctnursenav@kumc.edu
Lawrence
Lawrence Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Wichita
Ascension Via Christi Hospitals Wichita
Status: Active
Contact: Site Public Contact
Phone: 800-362-0070
Email: Keisha.humphries@ascension.org
Cancer Center of Kansas - Wichita
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: Active
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org
Wesley Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 316-268-5374
Email: Keisha.humphries@ascension.org

Kentucky

Lexington
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 859-257-3379

Louisiana

New Orleans
Ochsner Medical Center Jefferson
Status: Active
Contact: Site Public Contact
Phone: 504-703-8712
Email: Gregory.Johnstone@ochsner.org

Maine

Bangor
Eastern Maine Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 207-973-4274
Brewer
Lafayette Family Cancer Center-EMMC
Status: Active
Contact: Site Public Contact
Phone: 800-987-3005

Massachusetts

Boston
Dana-Farber Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 877-442-3324

Michigan

Adrian
Hickman Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 517-265-0116
Detroit
Henry Ford Hospital
Status: Active
Contact: Site Public Contact
Phone: 313-916-3721
Email: CTOResearch@hfhs.org
Grand Rapids
Mercy Health Saint Mary's
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Spectrum Health at Butterworth Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Kalamazoo
West Michigan Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Monroe
Toledo Clinic Cancer Centers-Monroe
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-444-3561
Muskegon
Mercy Health Mercy Campus
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: connie.szczepanek@crcwm.org
Reed City
Spectrum Health Reed City Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Saint Joseph
Marie Yeager Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Traverse City
Munson Medical Center
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org
Wyoming
Metro Health Hospital
Status: Active
Contact: Site Public Contact
Phone: 616-391-1230
Email: crcwm-regulatory@crcwm.org

Minnesota

Burnsville
Fairview Ridges Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Edina
Fairview-Southdale Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Fridley
Unity Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maple Grove
Fairview Maple Grove Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Minneapolis
Abbott-Northwestern Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Health Partners Inc
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Monticello
Monticello Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
New Ulm
New Ulm Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Robbinsdale
North Memorial Medical Health Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Cloud
Coborn Cancer Center at Saint Cloud Hospital
Status: Active
Contact: Site Public Contact
Phone: 877-229-4907
Email: coborncancercenter@centracare.com
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
United Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Shakopee
Saint Francis Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Stillwater
Lakeview Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Waconia
Ridgeview Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Willmar
Rice Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Wyoming
Fairview Lakes Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Missouri

Bonne Terre
Parkland Health Center-Bonne Terre
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569
Cape Girardeau
Saint Francis Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-334-2230
Email: sfmc@sfmc.net
Southeast Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-651-5550
Creve Coeur
Siteman Cancer Center at West County Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Jefferson City
Capital Region Southwest Campus
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 573-632-4814
Email: swooden@mail.crmc.org
Saint Louis
Missouri Baptist Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569
Siteman Cancer Center at Christian Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Siteman Cancer Center-South County
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Washington University School of Medicine
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Saint Peters
Siteman Cancer Center at Saint Peters Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-600-3606
Email: info@siteman.wustl.edu
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569
Sullivan
Missouri Baptist Sullivan Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569
Sunset Hills
Missouri Baptist Outpatient Center-Sunset Hills
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 314-996-5569

Montana

Anaconda
Community Hospital of Anaconda
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Bozeman
Bozeman Deaconess Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls Clinic
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Helena
Saint Peter's Community Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Nebraska

Omaha
Nebraska Methodist Hospital
Status: Active
Contact: Site Public Contact
Phone: 402-354-5144

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: Active
Contact: Site Public Contact
Phone: 800-639-6918
Email: cancer.research.nurse@dartmouth.edu

New York

Lake Success
Northwell Health / Center for Advanced Medicine
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896
Manhasset
North Shore University Hospital
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896
New Hyde Park
Long Island Jewish Medical Center
Status: Active
Contact: Site Public Contact
Phone: 516-734-8896
New York
Mount Sinai Hospital
Status: Active
Contact: Site Public Contact
Phone: 212-824-7309
Email: CCTO@mssm.edu
Rochester
University of Rochester
Status: Active
Contact: Site Public Contact
Phone: 585-275-5830

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Durham
Duke University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-275-3853
Winston-Salem
Wake Forest University Health Sciences
Status: Active
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Fargo
Sanford Broadway Medical Center
Status: Active
Contact: Site Public Contact
Phone: 701-323-5760
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Roger Maris Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 701-234-6161
Email: OncologyClinicalTrialsFargo@sanfordhealth.org

Ohio

Cleveland
MetroHealth Medical Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 216-778-8526
Email: dstrater@metrohealth.org
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-293-5066
Email: Jamesline@osumc.edu
Perrysburg
Mercy Health Perrysburg Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 419-479-5605
Email: pshoup@toledoclinic.com
Toledo
Mercy Saint Anne Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-407-1160
Toledo Clinic Cancer Centers-Toledo
Status: Active
Contact: Site Public Contact
Phone: 800-444-3561

Oklahoma

Oklahoma City
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Ontario
Saint Alphonsus Medical Center-Ontario
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Portland
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org

South Carolina

Greenville
Prisma Health Cancer Institute - Eastside
Status: Active
Contact: Site Public Contact
Phone: 864-522-2066
Email: kim.williams3@prismahealth.org
Saint Francis Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org
Saint Francis Hospital
Status: Active
Contact: Site Public Contact
Phone: 864-603-6213
Email: meissa_beckman@bshsi.org

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicTrialsSF@sanfordhealth.org
Sanford USD Medical Center - Sioux Falls
Status: Active
Contact: Site Public Contact
Phone: 605-312-3320
Email: OncologyClinicalTrialsSF@SanfordHealth.org

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-811-8480

Wisconsin

New Richmond
Cancer Center of Western Wisconsin
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Wyoming

Cody
Billings Clinic-Cody
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Sheridan
Welch Cancer Center
Status: Temporarily closed to accrual
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Compare the event-free survival (EFS) of daunorubicin, cytarabine plus uproleselan versus daunorubicin and cytarabine in subjects >= age 60 with previously untreated acute myeloid leukemia. (Phase II)

II. Compare the overall survival (OS) of the daunorubicin, cytarabine plus uproleselan to daunorubicin and cytarabine in this patient population. (Phase III)

SECONDARY OBJECTIVES:

I. Determine the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), complete remission with incomplete hematopoietic recovery (CRh) and cytogenetic complete remission (CCyR) for each chemotherapy regimen.

II. Determine the overall survival (OS), and remission duration of patients for each chemotherapy regimen.

III. Describe the frequency and severity of adverse events for patients for each chemotherapy regimen.

IV. Describe the interaction of pretreatment disease and patient characteristics including morphology, cytogenetics, molecular genetic features, white blood cell (WBC) count and hemogram, and performance status on clinical outcomes.

CORRELATIVE SCIENCE OBJECTIVES:

I. Correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters and with response rates, response duration, survival and cure in patients treated with various induction and post-induction regimens.

II. Correlate specific karyotype groups with selected molecular abnormalities and with measurable residual disease.

III. To determine karyotype changes at end of consolidation and the influence of the type of change (or no change) in karyotype at the end of consolidation on subsequent clinical course.

IV. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse on subsequent clinical course.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1: INDUCTION: Patients receive daunorubicin intravenously (IV) on days 1-3 and cytarabine via continuous intravenous infusion (CIVI) over 168 hours on days 1-7. Patients with residual disease indicated by bone marrow examination receive a second induction including daunorubicin IV on days 1-3 and cytarabine CIVI over 12 hours on days 1-5.

CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

GROUP 2: INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168 hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow examination receive a second induction including uprleselan IV QD on day 1 and then every 12 hours on days 2-10, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days 2-6.

CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every 12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 1 year, every 3 months in year 2, and then every 6 months for up to 5 years.

Trial Phase & Type

Trial Phase

Phase II/III

Trial Type

Treatment

Lead Organization

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Geoffrey L. Uy

Trial IDs

Primary ID A041701
Secondary IDs NCI-2018-02130
Clinicaltrials.gov ID NCT03701308