Acute Myeloid Leukemia Clinical Trial

Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia

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

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

≥18 years and ≤75 years in age
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:

Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML.
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.

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

388

Study ID:

NCT03616470

Recruitment Status:

Active, not recruiting

Sponsor:

GlycoMimetics Incorporated

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There are 65 Locations for this study

See Locations Near You

UC San Diego Moore Cancer Center
La Jolla California, 92093, United States
University of California, Los Angeles - UCLA
Los Angeles California, 90095, United States
University of California Irvine
Orange California, 92868, United States
Stanford Cancer Institute
Palo Alto California, 94304, United States
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States
Emory Winship Cancer Institute
Atlanta Georgia, 30322, United States
Northside Hospital - Medical Tower
Atlanta Georgia, 30342, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
The University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Hudson Valley Cancer Center
Hawthorne New York, 10532, United States
Columbia University Herbert Irving Comprehensive Cancer Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Weill Cornell Medical College
New York New York, 10065, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
Duke University Health System (DUHS)
Durham North Carolina, 27710, United States
Wake Forest Baptist Hospital
Winston-Salem North Carolina, 27157, United States
University Hospital Cleveland Medical Center
Cleveland Ohio, 44106, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
The Ohio State University Wexner Medical Center and James Cancer Hospital
Columbus Ohio, 43210, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Vanderbilt-Ingram Cancer Center Clinical Trials Office
Nashville Tennessee, 37203, United States
Charles A. Sammons Cancer Center at Dallas
Dallas Texas, 75246, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Huntsman Cancer Institute, University of Utah
Salt Lake City Utah, 84112, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Calvary Mater Newcastle
Waratah New South Wales, 2298, Australia
Sir Charles Gairdner Hospital
Nedlands Perth, 6009, Australia
Townsville Hospital
Douglas Queensland, 4814, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Flinders Medical Centre
Bedford Park South Australia, 5042, Australia
Cancer Clinical Trials Centre (CCTC)
Heidelberg Victoria, 3084, Australia
Tom Baker Cancer Center
Calgary Alberta, T2N 4, 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, R3E0V, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Centre Hospitalier Universitaire d'Angers
Angers , 49933, France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux , 33604, France
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche , 38700, France
Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO)
Marseille , 13273, France
Saint-Louis Hospital
Paris , 75010, France
Centre Hospitalier Lyon Sud
Pierre-Bénite , 75010, France
Centre Hospitalier Universitaire de Poitiers
Poitiers , 86021, France
Galway University Hospital
Galway , H91 T, Ireland
IRCCS Casa Sollievo della Sofferenza Hospital
San Giovanni Rotondo FG, , Italy
Institute of Hematology and Medical Oncology "L. and A. Seràgnoli"
Bologna , 40138, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola , 47014, Italy
Hospital of Ravenna
Ravenna , 48121, Italy
Fondazione Policlinico Tor Vergata, U.O.C. Ematologia
Roma , 00133, Italy
Università Cattolica del Sacro Cuore (UNICATT)
Rome , 00168, Italy
Ca' Foncello Hospital
Treviso , 31100, Italy
VU University Medical Center
Amsterdam , 1081 , Netherlands
University Medical Center Groningen
Groningen , 9713 , Netherlands
University Medical Centre Utrecht
Utrecht , 3584, Netherlands
Hospital San Pedro De Alcantra
Cáceres , 10003, Spain
Hospital MDACC
Madrid , 28033, Spain
Hospital Universitario Fundación Jiménez Diaz
Madrid , 28040, Spain
Hospital Virgen de la Victoria, Málaga
Málaga , 29010, Spain
Clínica Universidad de Navarra
Pamplona , 31008, Spain
Hospital Universitario de Salamanca
Salamanca , 37007, Spain
University Hospital of Hospital Marqués de Valdecilla
Santander , 39008, Spain
Hospital Universitari i Politècnic La Fe
Valencia , 46026, Spain
Radcliffe Hospitals and University of Oxford
Oxford England, OX3 7, United Kingdom
Cardiff University School of Medicine
Cardiff , CF14 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 3

Estimated Enrollment:

388

Study ID:

NCT03616470

Recruitment Status:

Active, not recruiting

Sponsor:


GlycoMimetics Incorporated

How clear is this clinincal trial information?

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