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NCT03701308Active, not recruitingPhase 2/3

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

A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Source: ClinicalTrials.gov · Last updated 21 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
267 (actual)
First submitted
8 Oct 2018
Start date
28 Mar 2019
Primary completion date
1 Oct 2024
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT03701308

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 267
  • From 28 Mar 2019 to the primary completion date, 1 Oct 2024
  • 188 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • 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 central nervous system (CNS) involvement of AML.
  • No prior chemotherapy for myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MPN) or AML including hypomethylating agents (e.g. azacitidine and decitabine), ruxolitinib 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.
  • Age \>= 60 years.
  • 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

Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (188)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hickman Cancer Center
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AdrianUnited StatesUnknown status
Mary Greeley Medical Center
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AmesUnited StatesUnknown status
McFarland Clinic - Ames
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AmesUnited StatesUnknown status
Community Hospital of Anaconda
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AnacondaUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Baker City
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Baker CityUnited StatesUnknown status
Eastern Maine Medical Center
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BangorUnited StatesUnknown status
Billings Clinic Cancer Center
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BillingsUnited StatesUnknown status
Sanford Bismarck Medical Center
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BismarckUnited StatesUnknown status
Illinois CancerCare-Bloomington
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BloomingtonUnited StatesUnknown status
Saint Luke's Cancer Institute - Boise
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BoiseUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Boise
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BoiseUnited StatesUnknown status
Parkland Health Center-Bonne Terre
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Bonne TerreUnited StatesUnknown status
McFarland Clinic - Boone
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BooneUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Bozeman Health Deaconess Hospital
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BozemanUnited StatesUnknown status
Lafayette Family Cancer Center-EMMC
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BrewerUnited StatesUnknown status
Fairview Ridges Hospital
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BurnsvilleUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Caldwell
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CaldwellUnited StatesUnknown status
Illinois CancerCare-Canton
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CantonUnited StatesUnknown status
Saint Francis Medical Center
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Cape GirardeauUnited StatesUnknown status
Mercy Cancer Center - Cape Girardeau
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Cape GirardeauUnited StatesUnknown status
Memorial Hospital of Carbondale
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CarbondaleUnited StatesUnknown status
SIH Cancer Institute
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CartervilleUnited StatesUnknown status
Illinois CancerCare-Carthage
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CarthageUnited StatesUnknown status
Centralia Oncology Clinic
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CentraliaUnited StatesUnknown status
UNC Lineberger Comprehensive Cancer Center
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Chapel HillUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Northwestern University
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ChicagoUnited StatesUnknown status
University of Chicago Comprehensive Cancer Center
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ChicagoUnited StatesUnknown status
University of Illinois
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ChicagoUnited StatesUnknown status
Siteman Cancer Center at Saint Peters Hospital
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City of Saint PetersUnited StatesUnknown status
Case Western Reserve University
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ClevelandUnited StatesUnknown status
MetroHealth Medical Center
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ClevelandUnited StatesUnknown status
Community Cancer Institute
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ClovisUnited StatesUnknown status
Billings Clinic-Cody
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CodyUnited StatesUnknown status
Kootenai Health - Coeur d'Alene
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Coeur d'AleneUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
Mercy Hospital
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Coon RapidsUnited StatesUnknown status
Siteman Cancer Center at West County Hospital
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Creve CoeurUnited StatesUnknown status
Geisinger Medical Center
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DanvilleUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
Essentia Health Cancer Center
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DuluthUnited StatesUnknown status
Duke University Medical Center
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DurhamUnited StatesUnknown status
Marshfield Medical Center-EC Cancer Center
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Eau ClaireUnited StatesUnknown status
Fairview Southdale Hospital
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EdinaUnited StatesUnknown status
Crossroads Cancer Center
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EffinghamUnited StatesUnknown status
Walter Knox Memorial Hospital
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EmmettUnited StatesUnknown status
Illinois CancerCare-Eureka
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EurekaUnited StatesUnknown status
NorthShore University HealthSystem-Evanston Hospital
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EvanstonUnited StatesUnknown status
Sanford Roger Maris Cancer Center
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FargoUnited StatesUnknown status
Sanford Broadway Medical Center
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FargoUnited StatesUnknown status
Parkland Health Center - Farmington
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FarmingtonUnited StatesUnknown status
McFarland Clinic - Trinity Cancer Center
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Fort DodgeUnited StatesUnknown status
Unity Hospital
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FridleyUnited StatesUnknown status
Western Illinois Cancer Treatment Center
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GalesburgUnited StatesUnknown status
Illinois CancerCare-Galesburg
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GalesburgUnited StatesUnknown status
NorthShore University HealthSystem-Glenbrook Hospital
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GlenviewUnited StatesUnknown status
Trinity Health Grand Rapids Hospital
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Grand RapidsUnited StatesUnknown status
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
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Grand RapidsUnited StatesUnknown status
Benefis Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
Great Falls Clinic
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Great FallsUnited StatesUnknown status
Saint Francis Cancer Center
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GreenvilleUnited StatesUnknown status
Prisma Health Cancer Institute - Eastside
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GreenvilleUnited StatesUnknown status
Saint Francis Hospital
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GreenvilleUnited StatesUnknown status
East Carolina University
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GreenvilleUnited StatesUnknown status
Smilow Cancer Hospital Care Center at Saint Francis
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HartfordUnited StatesUnknown status
Saint Peter's Community Hospital
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HelenaUnited StatesUnknown status
NorthShore University HealthSystem-Highland Park Hospital
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Highland ParkUnited StatesUnknown status
Indiana University/Melvin and Bren Simon Cancer Center
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IndianapolisUnited StatesUnknown status
University of Iowa/Holden Comprehensive Cancer Center
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Iowa CityUnited StatesUnknown status
McFarland Clinic - Jefferson
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JeffersonUnited StatesUnknown status
MU Health Care Goldschmidt Cancer Center
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Jefferson CityUnited StatesUnknown status
Bronson Methodist Hospital
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KalamazooUnited StatesUnknown status
West Michigan Cancer Center
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KalamazooUnited StatesUnknown status
Beacon Kalamazoo Cancer Center
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KalamazooUnited StatesUnknown status
Logan Health Medical Center
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KalispellUnited StatesUnknown status
University of Kansas Cancer Center
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Kansas CityUnited StatesUnknown status
Kadlec Clinic Hematology and Oncology
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KennewickUnited StatesUnknown status
Illinois CancerCare-Kewanee Clinic
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KewaneeUnited StatesUnknown status
UC San Diego Moores Cancer Center
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La JollaUnited StatesUnknown status
Northwell Health/Center for Advanced Medicine
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Lake SuccessUnited StatesUnknown status
OptumCare Cancer Care at Charleston
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Las VegasUnited StatesUnknown status
OptumCare Cancer Care at Fort Apache
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Las VegasUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada - Central Valley
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Las VegasUnited StatesUnknown status
Lawrence Memorial Hospital
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LawrenceUnited StatesUnknown status
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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LebanonUnited StatesUnknown status
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Loma Linda University Medical Center
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Loma LindaUnited StatesUnknown status
Cedars-Sinai Medical Center
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Los AngelesUnited StatesUnknown status
Illinois CancerCare-Macomb
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MacombUnited StatesUnknown status
North Shore University Hospital
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ManhassetUnited StatesUnknown status
Fairview Clinics and Surgery Center Maple Grove
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Maple GroveUnited StatesUnknown status
Saint John's Hospital - Healtheast
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MaplewoodUnited StatesUnknown status
Minnesota Oncology Hematology PA-Maplewood
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MaplewoodUnited StatesUnknown status
McFarland Clinic - Marshalltown
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MarshalltownUnited StatesUnknown status
Marshfield Medical Center-Marshfield
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MarshfieldUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Idaho Urologic Institute-Meridian
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MeridianUnited StatesUnknown status
Health Partners Inc
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MinneapolisUnited StatesUnknown status
Abbott-Northwestern Hospital
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MinneapolisUnited StatesUnknown status
Hennepin County Medical Center
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MinneapolisUnited StatesUnknown status
Marshfield Medical Center - Minocqua
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MinocquaUnited StatesUnknown status
Saint Patrick Hospital - Community Hospital
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MissoulaUnited StatesUnknown status
Community Medical Center
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MissoulaUnited StatesUnknown status
Toledo Clinic Cancer Centers-Monroe
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MonroeUnited StatesUnknown status
Monticello Cancer Center
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MonticelloUnited StatesUnknown status
Morristown Medical Center
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MorristownUnited StatesUnknown status
Trinity Health Muskegon Hospital
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MuskegonUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Nampa
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NampaUnited StatesUnknown status
Vanderbilt University/Ingram Cancer Center
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NashvilleUnited StatesUnknown status
Helen F Graham Cancer Center
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NewarkUnited StatesUnknown status
Christiana Care Health System-Christiana Hospital
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NewarkUnited StatesUnknown status
Medical Oncology Hematology Consultants PA
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NewarkUnited StatesUnknown status
Delaware Clinical and Laboratory Physicians PA
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NewarkUnited StatesUnknown status
Yale University
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New HavenUnited StatesUnknown status
Long Island Jewish Medical Center
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New Hyde ParkUnited StatesUnknown status
UC Comprehensive Cancer Center at Silver Cross
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New LenoxUnited StatesUnknown status
Ochsner Medical Center Jefferson
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New OrleansUnited StatesUnknown status
Cancer Center of Western Wisconsin
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New RichmondUnited StatesUnknown status
New Ulm Medical Center
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New UlmUnited StatesUnknown status
Mount Sinai Hospital
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New YorkUnited StatesUnknown status
Cancer and Hematology Centers of Western Michigan - Norton Shores
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Norton ShoresUnited StatesUnknown status
Cancer Care Center of O'Fallon
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O'FallonUnited StatesUnknown status
University of Oklahoma Health Sciences Center
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Oklahoma CityUnited StatesUnknown status
Nebraska Methodist Hospital
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OmahaUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Ontario
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OntarioUnited StatesUnknown status
University of Chicago Medicine-Orland Park
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Orland ParkUnited StatesUnknown status
Illinois CancerCare-Ottawa Clinic
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OttawaUnited StatesUnknown status
Illinois CancerCare-Pekin
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PekinUnited StatesUnknown status
Illinois CancerCare-Peoria
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PeoriaUnited StatesUnknown status
Methodist Medical Center of Illinois
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PeoriaUnited StatesUnknown status
Mercy Health - Perrysburg Hospital
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PerrysburgUnited StatesUnknown status
Illinois CancerCare-Peru
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PeruUnited StatesUnknown status
Valley Radiation Oncology
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PeruUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Providence Saint Vincent Medical Center
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PortlandUnited StatesUnknown status
Kootenai Clinic Cancer Services - Post Falls
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Post FallsUnited StatesUnknown status
Illinois CancerCare-Princeton
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PrincetonUnited StatesUnknown status
Rhode Island Hospital
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ProvidenceUnited StatesUnknown status
Corewell Health Reed City Hospital
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Reed CityUnited StatesUnknown status
Marshfield Medical Center-Rice Lake
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Rice LakeUnited StatesUnknown status
North Memorial Medical Health Center
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RobbinsdaleUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
Coborn Cancer Center at Saint Cloud Hospital
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Saint CloudUnited StatesUnknown status
Sainte Genevieve County Memorial Hospital
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Sainte GenevieveUnited StatesUnknown status
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
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Saint JosephUnited StatesUnknown status
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesUnknown status
United Hospital
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Saint PaulUnited StatesUnknown status
Regions Hospital
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Saint PaulUnited StatesUnknown status
Kootenai Clinic Cancer Services - Sandpoint
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SandpointUnited StatesUnknown status
Saint Francis Regional Medical Center
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ShakopeeUnited StatesUnknown status
Welch Cancer Center
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SheridanUnited StatesUnknown status
Siouxland Regional Cancer Center
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Sioux CityUnited StatesUnknown status
Sanford USD Medical Center - Sioux Falls
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Sioux FallsUnited StatesUnknown status
Sanford Cancer Center Oncology Clinic
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Sioux FallsUnited StatesUnknown status
Springfield Memorial Hospital
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SpringfieldUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Springfield Clinic
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SpringfieldUnited StatesUnknown status
Marshfield Medical Center-River Region at Stevens Point
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Stevens PointUnited StatesUnknown status
Lakeview Hospital
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StillwaterUnited StatesUnknown status
Missouri Baptist Medical Center
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St LouisUnited StatesUnknown status
Washington University School of Medicine
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St LouisUnited StatesUnknown status
Siteman Cancer Center-South County
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St LouisUnited StatesUnknown status
Siteman Cancer Center at Christian Hospital
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St LouisUnited StatesUnknown status
Missouri Baptist Sullivan Hospital
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SullivanUnited StatesUnknown status
Overlook Hospital
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SummitUnited StatesUnknown status
BJC Outpatient Center at Sunset Hills
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Sunset HillsUnited StatesUnknown status
Southwest Illinois Health Services LLP
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SwanseaUnited StatesUnknown status
Toledo Clinic Cancer Centers-Toledo
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ToledoUnited StatesUnknown status
Mercy Health - Saint Anne Hospital
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ToledoUnited StatesUnknown status
Munson Medical Center
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Traverse CityUnited StatesUnknown status
Ridgeview Medical Center
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WaconiaUnited StatesUnknown status
Marshfield Medical Center - Weston
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WestonUnited StatesUnknown status
Cancer Center of Kansas-Wichita Medical Arts Tower
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WichitaUnited StatesUnknown status
Wesley Medical Center
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WichitaUnited StatesUnknown status
Cancer Center of Kansas - Wichita
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WichitaUnited StatesUnknown status
Ascension Via Christi Hospitals Wichita
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WichitaUnited StatesUnknown status
Geisinger Wyoming Valley/Henry Cancer Center
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Wilkes-BarreUnited StatesUnknown status
Wake Forest Baptist Health - Wilkes Medical Center
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WilkesboroUnited StatesUnknown status
Rice Memorial Hospital
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WillmarUnited StatesUnknown status
Wake Forest University Health Sciences
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Winston-SalemUnited StatesUnknown status
Minnesota Oncology Hematology PA-Woodbury
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WoodburyUnited StatesUnknown status
University of Michigan Health - West
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WyomingUnited StatesUnknown status
Fairview Lakes Medical Center
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WyomingUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.