Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
NCT ID: NCT03616470
Last Updated: 2024-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
388 participants
INTERVENTIONAL
2018-10-15
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Uproleselan (GMI-1271)
Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
Uproleselan
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
Placebo (Saline, 0.9% Sodium Chloride)
Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
Placebo
Saline, 0.9% Sodium Chloride
Interventions
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Uproleselan
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
Placebo
Saline, 0.9% Sodium Chloride
Eligibility Criteria
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Inclusion Criteria
* Patients with relapsed or refractory AML
* No more than one prior stem cell transplant
* Has not received the chemotherapy regimen to be used for induction on this trial
* Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial
Exclusion Criteria
* Active signs or symptoms of CNS involvement by malignancy.
* Stem cell transplantation ≤4 months prior to dosing.
* Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing.
* Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.
* Inadequate organ function.
* Abnormal liver function.
* Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.
* Moderate kidney dysfunction (glomerular filtration rate \<45 mL/min).
* Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
* Clinically significant cardiovascular disease.
* Major surgery within 4 weeks of dosing.
18 Years
75 Years
ALL
No
Sponsors
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GlycoMimetics Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel J DeAngelo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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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
St 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
Countries
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Other Identifiers
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GMI-1271-301
Identifier Type: -
Identifier Source: org_study_id
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