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NCT00658814Active, not recruitingPhase 2

Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia

A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia

Source: ClinicalTrials.gov · Last updated 22 Oct 2026

Brief summary (registry, in English)

This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab ozogamicin to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab ozogamicin may kill more cancer cells.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
133 (actual)
First submitted
12 Apr 2008
Start date
1 Dec 2008
Primary completion date
1 Jun 2013
Lead sponsor
National Cancer Institute (NCI)
NCT number
NCT00658814

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 133
  • From 1 Dec 2008 to the primary completion date, 1 Jun 2013
  • 177 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

  • Morphologically confirmed diagnosis of acute myeloid leukemia (AML) with classification other than WHO acute promyelocytic leukemia (FAB M3), based on bone marrow examination performed within 14 days prior to registration; patients with World Health Organization (WHO) acute promyelocytic leukemia (FAB M3) or blastic transformation of chronic myelogenous leukemia are not eligible
  • Zubrod performance status 0-3
  • No known hypersensitivity to azacitidine, mannitol, hydroxyurea, orgemtuzumab ozogamicin
  • No prior systemic chemotherapy for acute leukemia with the exception of hydroxyurea; administration of hydroxyurea to control high white blood cell (WBC) count prior to registration is permitted
  • Patients with a history of prior myelodysplastic syndrome (MDS) are eligible according to the following criteria:
    • No prior treatment of MDS with AML induction-type chemotherapy or high-dose chemotherapy with hematopoietic stem cell support
    • Prior cytarabine allowed if dose \< 100 mg/m\^2/day
    • Prior hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide, and signal transduction inhibitors for treatment of MDS allowed
    • No prior treatment with azacitidine, decitabine, or gemtuzumab ozogamicin
    • At least 30 days since prior therapy for MDS and recovered
  • Bilirubin =\< 2.0 x institutional upper limit of normal (IULN) within 14 days to registration, unless the elevation is believed to be due to hepatic infiltration by AML
    • Hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert syndrome or hemolysis is allowed
  • Serum glutamic oxaloacetic transaminase (SGOT) aspartate aminotransferase (AST) =\< 2 x IULN, or serum glutamic pyruvate transaminase (SGPT) alanine aminotransferase (ALT) =\< 2.0 x IULN , unless the elevation is believed to be due to hepatic infiltration by AML
  • Serum creatinine =\< 1.5 x IULN
  • Left ventricle ejection fraction (LVEF) \>= 40% by multi-gated acquisition scan (MUGA) or echocardiogram (ECHO) AND no clinical evidence of congestive heart failure within the past 56 days
  • Pretreatment cytogenetics must be performed on all patients; collection of pretreatment specimens must be completed within 14 days prior to registration to S0703; specimens must be submitted to the site's preferred cytogenetics laboratory
  • Patients must consent to submit specimens to the Southwest Oncology Group (SWOG) acute lymphoblastic leukemia (ALL)/chronic lymphocytic leukemia (CLL)/chronic myelogenous leukemia (CML) repository for cellular and molecular studies; collection of pretreatment blood and/or marrow specimens must be completed within 14 days prior to registration; if a marrow specimen is available, either from the diagnostic marrow or a repeat pre-registration marrow, then it must be submitted along with a peripheral blood specimen; otherwise peripheral blood alone must be submitted; residual specimens will only be banked if the patient provides separate consent; sites are required to offer patients the opportunity to participate in banking
  • No central nervous system (CNS) involvement; if central nervous involvement is clinically suspected, it must be ruled out by a lumbar puncture
  • Women of reproductive potential must have a pregnancy test within 28 days prior to registration; patients must not be pregnant or nursing because of the teratogenic potential of the drugs used in this study; women/men of reproductive potential must have agreed to use an effective contraceptive method
  • Patients not known to be human immunodeficiency virus positive (HIV+) must be tested for HIV infection within 14 days prior to registration
  • HIV-positive patients must meet the following criteria:
    • No history of acquired immunodeficiency syndrome (AIDS)-defining events
    • CD4 cells \>= 500/mm\^3
    • Viral load of \< 50 copies HIV messenger ribonucleic acid (mRNA)/mm\^3 if on cART or \< 25,000 copies HIV mRNA if not on cART
    • No zidovudine or stavudine as part of cART Patients who are HIV+ and do not meet all of these criteria will not be eligible for this study
  • No other prior malignancy except for a) adequately treated basal cell or squamous cell skin cancer or b) any diagnosis of malignancy made within the past 2 years earlier, of which there is no clinically evident cancer, and for which the patient has completed all chemotherapy and radiotherapy at least 6 months prior to study registration; prior treatment with AML induction-type chemotherapy is not allowed; concurrent hormonal therapy is allowed
  • All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
  • At the time of patient registration, the treating institution's name and identification (ID) number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base
  • Patients must have complete remission (CR) or CRi, documented by blood and marrow examinations performed within 42 days before this registration
  • Following completion of induction therapy, the blood counts must recover to absolute neutrophil count (ANC) \>= 1,000/mcL and platelets \>= 90,000/mcL (without transfusion), and must be maintained at these levels during the 7 days prior to registration
  • Patients must have serum creatinine =\< 1.5 x IULN and SGOT or SGPT =\< 1.5 x IULN within 28 days before registration
  • Patients must have recovered to =\< Grade 2 from any induction cycle non-hematologic toxicities

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

Full criteria on ClinicalTrials.gov

Sites (177)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Cleveland Clinic Akron General
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AkronUnited StatesUnknown status
University of New Mexico Cancer Center
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AlbuquerqueUnited StatesUnknown status
OSF Saint Anthony's Health Center
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AltonUnited StatesUnknown status
The Don and Sybil Harrington Cancer Center
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AmarilloUnited StatesUnknown status
Cancer Care Center at Island Hospital
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AnacortesUnited StatesUnknown status
AnMed Health Hospital
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AndersonUnited StatesUnknown status
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Ann ArborUnited StatesUnknown status
University of Michigan Rogel Cancer Center
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Ann ArborUnited StatesUnknown status
Michigan Cancer Research Consortium NCORP
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Ann ArborUnited StatesUnknown status
Hospital District Sixth of Harper County
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AnthonyUnited StatesUnknown status
Hematology/Oncology Clinic PLLC
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Baton RougeUnited StatesUnknown status
Bronson Battle Creek
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Battle CreekUnited StatesUnknown status
Franciscan Saint Francis Health-Beech Grove
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Beech GroveUnited StatesUnknown status
Mary Rutan Hospital
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BellefontaineUnited StatesUnknown status
PeaceHealth Saint Joseph Medical Center
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BellinghamUnited StatesUnknown status
Spectrum Health Big Rapids Hospital
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Big RapidsUnited StatesUnknown status
Montana Cancer Consortium NCORP
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BillingsUnited StatesUnknown status
Saint Vincent Healthcare
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BillingsUnited StatesUnknown status
Northern Rockies Radiation Oncology Center
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BillingsUnited StatesUnknown status
Billings Clinic Cancer Center
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BillingsUnited StatesUnknown status
Saint Vincent Frontier Cancer Center
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BillingsUnited StatesUnknown status
Saint Alphonsus Cancer Care Center-Boise
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BoiseUnited StatesUnknown status
Bozeman Health Deaconess Hospital
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BozemanUnited StatesUnknown status
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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BurbankUnited StatesUnknown status
Saint Anne Hospital
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BurienUnited StatesUnknown status
Saint James Community Hospital and Cancer Treatment Center
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ButteUnited StatesUnknown status
Saint Francis Medical Center
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Cape GirardeauUnited StatesUnknown status
Southeast Missouri Hospital
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Cape GirardeauUnited StatesUnknown status
Rocky Mountain Oncology
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CasperUnited StatesUnknown status
Cancer Center of Kansas - Chanute
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ChanuteUnited StatesUnknown status
Medical University of South Carolina
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CharlestonUnited StatesUnknown status
Novant Health Presbyterian Medical Center
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CharlotteUnited StatesUnknown status
Adena Regional Medical Center
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ChillicotheUnited StatesUnknown status
University of Cincinnati Cancer Center-UC Medical Center
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CincinnatiUnited StatesUnknown status
Clackamas Radiation Oncology Center
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ClackamasUnited StatesUnknown status
Mount Carmel Health Center West
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ColumbusUnited StatesUnknown status
Columbus NCI Community Oncology Research Program
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ColumbusUnited StatesUnknown status
Grant Medical Center
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ColumbusUnited StatesUnknown status
Doctors Hospital
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ColumbusUnited StatesUnknown status
Riverside Methodist Hospital
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ColumbusUnited StatesUnknown status
Dayton NCI Community Oncology Research Program
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DaytonUnited StatesUnknown status
Good Samaritan Hospital - Dayton
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DaytonUnited StatesUnknown status
Miami Valley Hospital
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DaytonUnited StatesUnknown status
Miami Valley Hospital North
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DaytonUnited StatesUnknown status
Grandview Hospital
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DaytonUnited StatesUnknown status
Corewell Health Dearborn Hospital
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DearbornUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Heartland Cancer Research NCORP
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DecaturUnited StatesUnknown status
Grady Memorial Hospital
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DelawareUnited StatesUnknown status
Henry Ford Health Saint John Hospital
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DetroitUnited StatesUnknown status
Wayne State University/Karmanos Cancer Institute
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DetroitUnited StatesUnknown status
Cancer Center of Kansas - Dodge City
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Dodge CityUnited StatesUnknown status
Cancer Center of Kansas - El Dorado
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El DoradoUnited StatesUnknown status
Advocate Sherman Hospital
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ElginUnited StatesUnknown status
Blanchard Valley Hospital
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FindlayUnited StatesUnknown status
Hurley Medical Center
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FlintUnited StatesUnknown status
Genesys Regional Medical Center-West Flint Campus
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FlintUnited StatesUnknown status
Cancer Center of Kansas - Fort Scott
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Fort ScottUnited StatesUnknown status
Atrium Medical Center-Middletown Regional Hospital
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FranklinUnited StatesUnknown status
Wayne Memorial Hospital
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GoldsboroUnited 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
Cancer Research Consortium of West Michigan NCORP
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Grand RapidsUnited StatesUnknown status
Benefis Sletten Cancer Institute
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Great FallsUnited StatesUnknown status
Berdeaux, Donald MD (UIA Investigator)
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Great FallsUnited StatesUnknown status
Great Falls Clinic
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Great FallsUnited StatesUnknown status
Wayne Hospital
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GreenvilleUnited StatesUnknown status
Legacy Mount Hood Medical Center
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GreshamUnited StatesUnknown status
Smilow Cancer Hospital Care Center at Saint Francis
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HartfordUnited StatesUnknown status
Northern Montana Hospital
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HavreUnited StatesUnknown status
Saint Peter's Community Hospital
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HelenaUnited StatesUnknown status
Margaret R Pardee Memorial Hospital
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HendersonvilleUnited StatesUnknown status
Cancer Center of Kansas-Independence
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IndependenceUnited StatesUnknown status
Swedish Cancer Institute-Issaquah
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IssaquahUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Allegiance Health
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JacksonUnited StatesUnknown status
Logan Health Medical Center
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KalispellUnited StatesUnknown status
Glacier Oncology PLLC
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KalispellUnited StatesUnknown status
Kalispell Medical Oncology
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KalispellUnited StatesUnknown status
Saint Joseph Health Center
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Kansas CityUnited StatesUnknown status
University Health Truman Medical Center
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Kansas CityUnited StatesUnknown status
North Kansas City Hospital
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Kansas CityUnited StatesUnknown status
Saint Luke's Hospital of Kansas City
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Kansas CityUnited StatesUnknown status
Heartland Hematology and Oncology Associates Incorporated
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Kansas CityUnited StatesUnknown status
Research Medical Center
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Kansas CityUnited StatesUnknown status
Kadlec Clinic Hematology and Oncology
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KennewickUnited StatesUnknown status
Kettering Medical Center
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KetteringUnited StatesUnknown status
Cancer Center of Kansas-Kingman
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KingmanUnited StatesUnknown status
Fairfield Medical Center
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LancasterUnited StatesUnknown status
University of Michigan Health - Sparrow Lansing
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LansingUnited StatesUnknown status
Lawrence Memorial Hospital
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LawrenceUnited StatesUnknown status
Saint Luke's East - Lee's Summit
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Lee's SummitUnited StatesUnknown status
University of Kentucky/Markey Cancer Center
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LexingtonUnited StatesUnknown status
Cancer Center of Kansas-Liberal
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LiberalUnited StatesUnknown status
Southwest Medical Center
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LiberalUnited StatesUnknown status
Liberty Hospital
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LibertyUnited StatesUnknown status
Trinity Health Saint Mary Mercy Livonia Hospital
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LivoniaUnited StatesUnknown status
Marietta Memorial Hospital
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MariettaUnited StatesUnknown status
Loyola University Medical Center
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MaywoodUnited StatesUnknown status
Providence Milwaukie Hospital
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MilwaukieUnited StatesUnknown status
Montana Cancer Specialists
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MissoulaUnited StatesUnknown status
Guardian Oncology and Center for Wellness
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MissoulaUnited StatesUnknown status
Community Medical Center
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MissoulaUnited StatesUnknown status
Saint Patrick Hospital - Community Hospital
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MissoulaUnited StatesUnknown status
Knox Community Hospital
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Mount VernonUnited StatesUnknown status
Skagit Valley Hospital
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Mount VernonUnited StatesUnknown status
SSM Health Good Samaritan
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Mount VernonUnited StatesUnknown status
Trinity Health Muskegon Hospital
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MuskegonUnited StatesUnknown status
Licking Memorial Hospital
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NewarkUnited StatesUnknown status
Providence Newberg Medical Center
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NewbergUnited StatesUnknown status
Tulane University School of Medicine
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New OrleansUnited StatesUnknown status
Cancer Center of Kansas - Newton
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NewtonUnited StatesUnknown status
Providence Willamette Falls Medical Center
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Oregon CityUnited StatesUnknown status
Menorah Medical Center
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Overland ParkUnited StatesUnknown status
Saint Luke's South Hospital
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Overland ParkUnited StatesUnknown status
Stanford Cancer Institute Palo Alto
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Palo AltoUnited StatesUnknown status
Cancer Center of Kansas - Parsons
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ParsonsUnited StatesUnknown status
Trinity Health Saint Joseph Mercy Oakland Hospital
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PontiacUnited StatesUnknown status
Lake Huron Medical Center
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Port HuronUnited StatesUnknown status
Adventist Medical Center
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PortlandUnited StatesUnknown status
Legacy Good Samaritan Hospital and Medical Center
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PortlandUnited 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
Legacy Emanuel Hospital and Health Center
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PortlandUnited StatesUnknown status
Southern Ohio Medical Center
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PortsmouthUnited StatesUnknown status
Harrison HealthPartners Hematology and Oncology-Poulsbo
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PoulsboUnited StatesUnknown status
Kansas City NCI Community Oncology Research Program
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Prairie VillageUnited StatesUnknown status
Cancer Center of Kansas - Pratt
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PrattUnited StatesUnknown status
Reid Health
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RichmondUnited StatesUnknown status
University of Rochester
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RochesterUnited StatesUnknown status
Rutherford Hospital
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RutherfordtonUnited StatesUnknown status
University of California Davis Comprehensive Cancer Center
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SacramentoUnited StatesUnknown status
MyMichigan Medical Center Saginaw
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SaginawUnited StatesUnknown status
Heartland Regional Medical Center
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Saint JosephUnited StatesUnknown status
Salem Hospital
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SalemUnited StatesUnknown status
Salina Regional Health Center
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SalinaUnited StatesUnknown status
Cancer Center of Kansas - Salina
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SalinaUnited StatesUnknown status
Kaiser Permanente Washington
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SeattleUnited StatesUnknown status
Swedish Medical Center-First Hill
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SeattleUnited StatesUnknown status
Minor and James Medical PLLC
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SeattleUnited StatesUnknown status
University of Washington Medical Center - Montlake
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SeattleUnited StatesUnknown status
Harborview Medical Center
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SeattleUnited StatesUnknown status
Fred Hutchinson Cancer Center
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SeattleUnited StatesUnknown status
PeaceHealth United General Medical Center
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Sedro-WoolleyUnited StatesUnknown status
AdventHealth Shawnee Mission
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Shawnee MissionUnited StatesUnknown status
Welch Cancer Center
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SheridanUnited StatesUnknown status
Saint Joseph Medical Center Hematology and Oncology - Silverdale
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SilverdaleUnited StatesUnknown status
Henry Ford Health Providence Southfield Hospital
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SouthfieldUnited StatesUnknown status
Spartanburg Medical Center
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SpartanburgUnited StatesUnknown status
Evergreen Hematology and Oncology PS
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SpokaneUnited StatesUnknown status
Cancer Care Northwest - Spokane South
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SpokaneUnited StatesUnknown status
Springfield Memorial Hospital
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SpringfieldUnited StatesUnknown status
Springfield Regional Medical Center
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SpringfieldUnited StatesUnknown status
Mercy Hospital Saint Louis
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St LouisUnited StatesUnknown status
Saint Louis-Cape Girardeau CCOP
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St LouisUnited StatesUnknown status
Mercy Infusion Center - Chippewa
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St LouisUnited StatesUnknown status
Cotton O'Neil Cancer Center / Stormont Vail Health
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TopekaUnited StatesUnknown status
Munson Medical Center
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Traverse CityUnited StatesUnknown status
Upper Valley Medical Center
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TroyUnited StatesUnknown status
Legacy Meridian Park Hospital
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TualatinUnited StatesUnknown status
PeaceHealth Southwest Medical Center
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VancouverUnited StatesUnknown status
Henry Ford Health Warren Hospital
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WarrenUnited StatesUnknown status
Cancer Center of Kansas - Wellington
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WellingtonUnited StatesUnknown status
Wenatchee Valley Hospital and Clinics
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WenatcheeUnited StatesUnknown status
Saint Ann's Hospital
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WestervilleUnited StatesUnknown status
Ascension Via Christi Hospitals Wichita
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WichitaUnited StatesUnknown status
Cancer Center of Kansas-Wichita Medical Arts Tower
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WichitaUnited StatesUnknown status
Cancer Center of Kansas - Wichita
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WichitaUnited StatesUnknown status
Wesley Medical Center
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WichitaUnited StatesUnknown status
Associates In Womens Health
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WichitaUnited StatesUnknown status
Wichita NCI Community Oncology Research Program
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WichitaUnited StatesUnknown status
Clinton Memorial Hospital/Foster J Boyd Regional Cancer Center
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WilmingtonUnited StatesUnknown status
Cancer Center of Kansas - Winfield
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WinfieldUnited StatesUnknown status
Southeast Clinical Oncology Research Consortium NCORP
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Winston-SalemUnited StatesUnknown status
University of Michigan Health - West
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WyomingUnited StatesUnknown status
Greene Memorial Hospital
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XeniaUnited StatesUnknown status
Genesis Healthcare System Cancer Care Center
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ZanesvilleUnited StatesUnknown status

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