Protokol for udvidet adgang/compassionate use for recidiverende eller refraktær CD33-positive AML-patienter i USA uden adgang til sammenlignelig eller alternativ terapi (AML)
17. august 2019 opdateret af: Pfizer
GEMTUZUMAB OZOGAMICIN (MYLOTARG (REGISTERET)) UDVIDET ADGANGSPROTOKOL TIL BEHANDLING AF PATIENTER I USA MED GENTAGET/REFRAKTÆR AKUT MYELOGEN LEUKÆMI, SOM IKKE KAN GLÆDE ANDET AF KOMPLETTERENDE/
En udvidet adgangs-/compassionate use-protokol, der giver adgang til Mylotarg for recidiverende/refraktære AML CD33-positive patienter i USA.
Kontakt: B1761026@iconplc.com
Studieoversigt
Status
Ikke længere tilgængelig
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Kontakt:
B1761026@iconplc.com
Undersøgelsestype
Udvidet adgang
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alabama
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Birmingham, Alabama, Forenede Stater, 35233
- University of Alabama at Birmingham/Children's of Alabama
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Alaska
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Anchorage, Alaska, Forenede Stater, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, Forenede Stater, 99508
- Providence Cancer Center
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Anchorage, Alaska, Forenede Stater, 99508-2980
- Alaska Oncology & Hematology, LLC
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Arizona
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Mesa, Arizona, Forenede Stater, 85202
- Banner Pediatric Specialists Hematology/Oncology Clinic
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Mesa, Arizona, Forenede Stater, 85202
- Cardon Children's Medical Center.
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Phoenix, Arizona, Forenede Stater, 85016
- Phoenix Children's Hospital
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California
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Los Angeles, California, Forenede Stater, 90027
- Children's Hospital of Los Angeles - University of Southern California School of Medicine
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Oakland, California, Forenede Stater, 94611
- Kaiser Permanente - Oakland
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Oakland, California, Forenede Stater, 94611
- Kaiser Permanente - Oakland Medical Center
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Orange, California, Forenede Stater, 92868
- Children's Hospital of Orange County
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Roseville, California, Forenede Stater, 95661
- Kaiser Permanente - Roseville
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San Diego, California, Forenede Stater, 92123
- UCSD/ Rady Children's Hospital
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Santa Clara, California, Forenede Stater, 95051
- Kaiser Permanente - Santa Clara
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06520
- Yale University
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New Haven, Connecticut, Forenede Stater, 06510
- C/O Thomas Ferencz, RPh, BCOP, Smilow Cancer Hospital at Yale-New Haven
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New Haven, Connecticut, Forenede Stater, 06510
- Smilow Cancer Hospital at Yale-New Haven
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New Haven, Connecticut, Forenede Stater, 06510
- Yale New-Haven Hospital & Smilow Cancer Center
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Trumbull, Connecticut, Forenede Stater, 06611
- Yale Medical Group
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Delaware
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Wilmington, Delaware, Forenede Stater, 19803
- Nemours - A.I. duPont Hospital for Children
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20010
- Children's National Medical Center
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Florida
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Hollywood, Florida, Forenede Stater, 33021
- Memorial Regional Hospital
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Hollywood, Florida, Forenede Stater, 33021
- Joe DiMaggio Children's Hospital
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Hollywood, Florida, Forenede Stater, 33021
- JDCH pediatric Oncology and Hematology
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Jacksonville, Florida, Forenede Stater, 32207-8426
- Nemours Children's Clinic
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Jacksonville, Florida, Forenede Stater, 32207
- Baptist Medical Center/Wolfson Children's Hospital
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Orlando, Florida, Forenede Stater, 32804
- Florida Hospital Cancer Institute
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Orlando, Florida, Forenede Stater, 32827
- Nemours Children's Hospital
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Orlando, Florida, Forenede Stater, 32804
- Cancer Institute Of Florida
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Orlando, Florida, Forenede Stater, 32804
- Blood and Marrow Transplant Center
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Pembroke Pines, Florida, Forenede Stater, 33021
- Memorial Cancer Institute at Memorial Hospital West
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Pembroke Pines, Florida, Forenede Stater, 33021
- Memorial Hospital West
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Saint Petersburg, Florida, Forenede Stater, 33701
- Johns Hopkins All Children's Hospital
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Saint Petersburg, Florida, Forenede Stater, 33701
- Johns Hopkins All Children's Hospital IDS Pharmacy
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Saint Petersburg, Florida, Forenede Stater, 33701
- Johns Hopkins All Children's Outpatient Care Pediatric Hematology/Oncology Department
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Tampa, Florida, Forenede Stater, 33612
- H.Lee Moffitt Cancer Center and Research Institute
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Georgia
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Atlanta, Georgia, Forenede Stater, 30342
- Children's Healthcare of Atlanta at Scottish Rite
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Atlanta, Georgia, Forenede Stater, 30342
- Northside Hospital
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Atlanta, Georgia, Forenede Stater, 30322
- Children's Healthcare of Atlanta at Egleston
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Atlanta, Georgia, Forenede Stater, 30342-4790
- The Blood & Marrow Transplant Group Of Georgia
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Ann & Robert H. Lurie Children's Hospital of Chicago
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Chicago, Illinois, Forenede Stater, 60637
- University of Chicago Medical Center
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Chicago, Illinois, Forenede Stater, 60637
- The University of Chicago
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Chicago, Illinois, Forenede Stater, 60637
- The University of Chicago Medical Center
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Chicago, Illinois, Forenede Stater, 60637
- Investigational Drugs Service Pharmacy, Attn. Judy Pi, PharmD, Ami Patel, PharmD
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Medical Center
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Maywood, Illinois, Forenede Stater, 60153
- Cardinal Bernardin Cancer Center/Loyola University Medical Center
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Maywood, Illinois, Forenede Stater, 60153
- Loyola University Chicago, performing research at Loyola University Medical Center
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- IU Health Pharmacy
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Indianapolis, Indiana, Forenede Stater, 46237
- Indiana Blood and Marrow Transplantation
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Indianapolis, Indiana, Forenede Stater, 46202-5225
- Indiana University Riley Hospital for Children
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Indianapolis, Indiana, Forenede Stater, 46237
- Indiana Blood and Marrow Transplantation - Administrative Offices
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Indianapolis, Indiana, Forenede Stater, 46237
- St.Francis Hospital
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Kansas
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Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Hospital
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Westwood, Kansas, Forenede Stater, 66205
- University of Kansas Cancer Center
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Westwood, Kansas, Forenede Stater, 66205
- The University of Kansas Cancer Center and Medical Pavilion
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Westwood, Kansas, Forenede Stater, 66205
- The University of Kansas Cancer Center and Medical Pavillion
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40536
- UK Healthcare Markey Cancer Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins University
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Baltimore, Maryland, Forenede Stater, 21231
- Johns Hopkins University IDS Pharmacy
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic
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Mississippi
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Southaven, Mississippi, Forenede Stater, 38671
- The West Clinic, P.C. dba West Cancer Center
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Missouri
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Creve Coeur, Missouri, Forenede Stater, 63141
- Siteman Cancer Center - West County
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Kansas City, Missouri, Forenede Stater, 64108
- Children's Mercy Hospital
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Saint Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine
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Saint Louis, Missouri, Forenede Stater, 63110
- Barnes-Jewish Hospital
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Saint Louis, Missouri, Forenede Stater, 63129
- Siteman Cancer Center - South County
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Saint Louis, Missouri, Forenede Stater, 63110
- Washington University Infusion Center Pharmacy
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Saint Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine, Siteman Cancer Center
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New Jersey
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New Brunswick, New Jersey, Forenede Stater, 08903
- Rutgers Cancer Institute of New Jersey
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New Brunswick, New Jersey, Forenede Stater, 08901
- Robert Wood Johnson University Hospital
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New York
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Buffalo, New York, Forenede Stater, 14263
- Roswell Park Cancer Institute
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East Setauket, New York, Forenede Stater, 11733
- North Shore Hematology Oncology Associates, P.C.
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New York, New York, Forenede Stater, 10065
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forenede Stater, 10021
- Weill Cornell Medical College - New York-Presbyterian Hospital
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New York, New York, Forenede Stater, 10065
- Weill Cornell Medical College - New York-Presbyterian Hospital
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
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Rochester, New York, Forenede Stater, 14642
- University of Rochester Cancer Center Pharmacy
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North Carolina
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Greenville, North Carolina, Forenede Stater, 27834
- Vidant Medical Center
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Greenville, North Carolina, Forenede Stater, 27834
- Brody School of Medicine at ECU
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals of Cleveland Rainbow Babies & Children's Hospital
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Columbus, Ohio, Forenede Stater, 43205
- Nationwide Children's Hospital
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Pennsylvania
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Danville, Pennsylvania, Forenede Stater, 17822
- Geisinger Medical Center
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Hershey, Pennsylvania, Forenede Stater, 17033
- Milton Hershey Medical Center
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- The Children's Hospital of Philadelphia
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University
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Philadelphia, Pennsylvania, Forenede Stater, 19134
- St. Christopher's Hospital for Children
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Philadelphia, Pennsylvania, Forenede Stater, 19107-4215
- Thomas Jefferson University (Tju) - Jefferson University Physicians (Jup)
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University, Investigative Drug Service
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Clinical)
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Philadelphia, Pennsylvania, Forenede Stater, 19107
- Thomas Jefferson University, Sidney Kimmel Cancer Center, Clinical Trials Office (Regulatory)
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Pittsburgh, Pennsylvania, Forenede Stater, 15224
- Allegheny Health Network, Cancer Institute, West Penn Hospital
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- The West Clinic, P.C. dba West Cancer Center
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Knoxville, Tennessee, Forenede Stater, 37916
- East Tennessee Children's Hospital
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Memphis, Tennessee, Forenede Stater, 38105
- St. Jude Children's Research Hospital
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Memphis, Tennessee, Forenede Stater, 38120
- Baptist Memorial Hospital
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Memphis, Tennessee, Forenede Stater, 38120
- The West Clinic, P.C. dba West Cancer Center
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Nashville, Tennessee, Forenede Stater, 37203
- Sarah Cannon Research Institute
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Nashville, Tennessee, Forenede Stater, 37232
- Monroe Carell Jr. Children's Hospital at Vanderbilt
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Nashville, Tennessee, Forenede Stater, 37203
- Tennessee Oncology, PLLC
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Nashville, Tennessee, Forenede Stater, 37203
- The Children's Hospital at TriStar Centennial
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Nashville, Tennessee, Forenede Stater, 37203
- Tennessee Oncology - Nashville
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Nashville, Tennessee, Forenede Stater, 37203
- TriStar Centennial Medical Center
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Nashville, Tennessee, Forenede Stater, 34203
- Sarah Cannon Research Institute
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Nashville, Tennessee, Forenede Stater, 37203
- Sarah Cannon Center for Blood Cancer
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Nashville, Tennessee, Forenede Stater, 37203
- TriStar Centennial Medical Center/Sarah Cannon Cener for Blood Cancer
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Nashville, Tennessee, Forenede Stater, 37203
- TriStar Medical Group Children's Specialist
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Nashville, Tennessee, Forenede Stater, 37212
- VA Tennessee Valley Healthcare System - Nashville Campus
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University Medical Center - The Vanderbilt Clinic
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Texas
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Austin, Texas, Forenede Stater, 78723
- Dell Children's Medical Center of Central Texas
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Austin, Texas, Forenede Stater, 78723
- Dell Children's Medical Center
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Austin, Texas, Forenede Stater, 78723
- Children's Blood and Cancer Center
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El Paso, Texas, Forenede Stater, 79905
- El Paso Children's Hospital
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El Paso, Texas, Forenede Stater, 79905
- Texas Tech University Health Sciences Center
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Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Medical Center
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Fort Worth, Texas, Forenede Stater, 76104
- Cook Children's Hematology/Oncology Center
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Grapevine, Texas, Forenede Stater, 76051
- Cook Children's Hematology/Oncology Center - Grapevine
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Houston, Texas, Forenede Stater, 77030
- Texas Children's Hospital
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Houston, Texas, Forenede Stater, 77030
- Houston Methodist Hospital
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Houston, Texas, Forenede Stater, 77030
- Texas Children's Hospital Attn: Investigational Pharmacy Services
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Houston, Texas, Forenede Stater, 77584
- Houston Methodist Cancer Center
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Utah
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Salt Lake City, Utah, Forenede Stater, 84113
- Primary Children's Hospital
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Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Institute-University of Utah
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Salt Lake City, Utah, Forenede Stater, 84112
- Huntsman Cancer Hospital
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- UVA Health System
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Charlottesville, Virginia, Forenede Stater, 22903
- Emily Couric Clinical Cancer Center
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Charlottesville, Virginia, Forenede Stater, 22903
- Cancer Center IDS Pharmacy Attn: Lauren Benusa, Pharm D.
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Hampton, Virginia, Forenede Stater, 23666
- Virginia Oncology Associates
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Norfolk, Virginia, Forenede Stater, 23507
- Children's Hospital of The King's Daughters
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Virginia Beach, Virginia, Forenede Stater, 23456
- Virginia Oncology Associates
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Washington
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Seattle, Washington, Forenede Stater, 98105
- Seattle Children's
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Seattle, Washington, Forenede Stater, 98104
- Swedish Medical Center First Hill, IDS Pharmacy
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Seattle, Washington, Forenede Stater, 98105
- Seattle Children's IDS Pharmacy - Attn. Laura Winter
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Seattle, Washington, Forenede Stater, 98122
- Lisa Nakatsu, RPh
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Wisconsin
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Appleton, Wisconsin, Forenede Stater, 59413
- Fox Valley Hematology & Oncology, SC
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Green Bay, Wisconsin, Forenede Stater, 54311
- Aurora BayCare Medical Center
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Medical College of Wisconsin
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Milwaukee, Wisconsin, Forenede Stater, 53226
- Children's Hospital of Wisconsin
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Oshkosh, Wisconsin, Forenede Stater, 59404
- Fox Valley Hematology & Oncology, SC
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Wauwatosa, Wisconsin, Forenede Stater, 53226
- Aurora Health Care, Aurora Cancer Care
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West Allis, Wisconsin, Forenede Stater, 53227
- Aurora Health Care, Aurora Cancer Care
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
3 år og ældre (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inklusionskriterier:
- Bekræftet diagnose af recidiverende/refraktær AML (defineret som >=5 % marvblaster efter morfologi), inklusive MDS, med vedvarende stigende blaster og ingen anden sammenlignelig eller tilfredsstillende alternativ behandling tilgængelig. Hvis knoglemarv har <5 % blaster efter morfologi, men patienten har tegn på tilbagefald med ekstra-medullær sygdomsprogression. I udvalgte tilfælde med konvertering af MRD fra negativ til positiv, kan behandling med GO tillades, hvor ingen alternative behandlinger er mulige.
ELLER
- Bekræftet diagnose af recidiverende eller refraktær APL med vedvarende eller stigende leukæmibelastning (enten ved morfologi, cytogenetisk analyse eller ved molekylære teknikker), og ingen anden sammenlignelig eller tilfredsstillende alternativ behandling tilgængelig.
Dokumentation for, at maligne celler udtrykker CD33
4) Alder >=3 måneder
5) Tilstrækkelig ikke-hæmatologisk organfunktion
Ekskluderingskriterier:
- Ubehandlet AML og MDS eller AML og MDS i fuldstændig remission.
- Patienter med en kendt historie med VOD/SOS.
- Patienter med en kendt overfølsomhed over for Mylotarg eller dets dele: hP67.6-antistof, calicheamicin-derivater eller andre ingredienser.
- Deltagelse i andre undersøgelser, der involverer forsøgslægemidler (fase 1-4) under undersøgelsesdeltagelsen.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Datoer for studieregistrering
Først indsendt
4. december 2014
Først indsendt, der opfyldte QC-kriterier
4. december 2014
Først opslået (Skøn)
9. december 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. august 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. august 2019
Sidst verificeret
1. august 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- B1761026
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .