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Brief Title: Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
Official Title: A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Study ID: NCT03616470
Brief Summary: This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UC San Diego Moore Cancer Center, La Jolla, California, United States
University of California, Los Angeles - UCLA, Los Angeles, California, United States
University of California Irvine, Orange, California, United States
Stanford Cancer Institute, Palo Alto, California, United States
UC Davis Comprehensive Cancer Center, Sacramento, California, United States
Emory Winship Cancer Institute, Atlanta, Georgia, United States
Northside Hospital - Medical Tower, Atlanta, Georgia, United States
Rush University Medical Center, Chicago, Illinois, United States
The University of Kansas Cancer Center, Westwood, Kansas, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Hudson Valley Cancer Center, Hawthorne, New York, United States
Columbia University Herbert Irving Comprehensive Cancer Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Weill Cornell Medical College, New York, New York, United States
University of Rochester Medical Center, Rochester, New York, United States
Duke University Health System (DUHS), Durham, North Carolina, United States
Wake Forest Baptist Hospital, Winston-Salem, North Carolina, United States
University Hospital Cleveland Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
The Ohio State University Wexner Medical Center and James Cancer Hospital, Columbus, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Vanderbilt-Ingram Cancer Center Clinical Trials Office, Nashville, Tennessee, United States
Charles A. Sammons Cancer Center at Dallas, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Calvary Mater Newcastle, Waratah, New South Wales, Australia
Sir Charles Gairdner Hospital, Nedlands, Perth, Australia
Townsville Hospital, Douglas, Queensland, Australia
Princess Alexandra Hospital, Woolloongabba, Queensland, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Cancer Clinical Trials Centre (CCTC), Heidelberg, Victoria, Australia
Tom Baker Cancer Center, Calgary, Alberta, Canada
University of Alberta Princess Margaret Hospital, Edmonton, Alberta, Canada
The Leukemia/BMT Program of BC Vancouver General Hospital, Vancouver, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
University Health Network (UHN) - Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Centre Hospitalier Universitaire d'Angers, Angers, , France
Centre Hospitalier Universitaire de Bordeaux, Bordeaux, , France
Centre Hospitalier Universitaire Grenoble Alpes, La Tronche, , France
Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO), Marseille, , France
Saint-Louis Hospital, Paris, , France
Centre Hospitalier Lyon Sud, Pierre-Bénite, , France
Centre Hospitalier Universitaire de Poitiers, Poitiers, , France
Galway University Hospital, Galway, , Ireland
IRCCS Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo, FG, Italy
Institute of Hematology and Medical Oncology "L. and A. Seràgnoli", Bologna, , Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), Meldola, , Italy
Hospital of Ravenna, Ravenna, , Italy
Fondazione Policlinico Tor Vergata, U.O.C. Ematologia, Roma, , Italy
Università Cattolica del Sacro Cuore (UNICATT), Rome, , Italy
Ca' Foncello Hospital, Treviso, , Italy
VU University Medical Center, Amsterdam, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
University Medical Centre Utrecht, Utrecht, , Netherlands
Hospital San Pedro De Alcantra, Cáceres, , Spain
Hospital MDACC, Madrid, , Spain
Hospital Universitario Fundación Jiménez Diaz, Madrid, , Spain
Hospital Virgen de la Victoria, Málaga, Málaga, , Spain
Clínica Universidad de Navarra, Pamplona, , Spain
Hospital Universitario de Salamanca, Salamanca, , Spain
University Hospital of Hospital Marqués de Valdecilla, Santander, , Spain
Hospital Universitari i Politècnic La Fe, Valencia, , Spain
Radcliffe Hospitals and University of Oxford, Oxford, England, United Kingdom
Cardiff University School of Medicine, Cardiff, , United Kingdom
Name: Daniel J DeAngelo, MD, PhD
Affiliation: Dana-Farber Cancer Institute
Role: PRINCIPAL_INVESTIGATOR