Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
- Registration Number
- NCT03616470
- Lead Sponsor
- GlycoMimetics Incorporated
- 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
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 388
- โฅ18 years and โค75 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
- 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 โค4 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Uproleselan (GMI-1271) Uproleselan Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI) Placebo (Saline, 0.9% Sodium Chloride) Placebo Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
- Primary Outcome Measures
Name Time Method Overall survival 5 years Time from the date of randomization into the study to the date of death.
- Secondary Outcome Measures
Name Time Method Overall response rate Up to 60 days Proportion of subjects who achieve a complete remission \[CR\] or CR with partial recovery \[CRh\] of blood counts
Rate of severe oral mucositis up to 60 days Incidence of severe oral mucositis experienced in patients after treatment.
Trial Locations
- Locations (70)
Rush University Medical Center
๐บ๐ธChicago, Illinois, United States
Cleveland Clinic
๐บ๐ธCleveland, Ohio, United States
Seattle Cancer Care Alliance
๐บ๐ธSeattle, Washington, United States
Radcliffe Hospitals and University of Oxford
๐ฌ๐งOxford, England, United Kingdom
Galway University Hospital
๐ฎ๐ชGalway, Ireland
University of Rochester Medical Center
๐บ๐ธRochester, New York, United States
Columbia University Herbert Irving Comprehensive Cancer Center
๐บ๐ธNew York, New York, United States
Roswell Park Cancer Institute
๐บ๐ธBuffalo, New York, United States
The Leukemia/BMT Program of BC Vancouver General Hospital
๐จ๐ฆVancouver, British Columbia, Canada
Hudson Valley Cancer Center
๐บ๐ธHawthorne, New York, United States
Northside Hospital - Medical Tower
๐บ๐ธAtlanta, Georgia, United States
University Hospital Cleveland Medical Center
๐บ๐ธCleveland, Ohio, United States
Weill Cornell Medical College
๐บ๐ธNew York, New York, United States
Princess Alexandra Hospital
๐ฆ๐บWoolloongabba, Queensland, Australia
University Medical Center Groningen
๐ณ๐ฑGroningen, Netherlands
IRCCS Casa Sollievo della Sofferenza Hospital
๐ฎ๐นSan Giovanni Rotondo, FG, Italy
Clรญnica Universidad de Navarra
๐ช๐ธPamplona, Spain
The University of Kansas Cancer Center
๐บ๐ธWestwood, Kansas, United States
Tom Baker Cancer Center
๐จ๐ฆCalgary, Alberta, Canada
University of Alberta Princess Margaret Hospital
๐จ๐ฆEdmonton, Alberta, Canada
Saint-Louis Hospital
๐ซ๐ทParis, France
Cancer Clinical Trials Centre (CCTC)
๐ฆ๐บHeidelberg, Victoria, Australia
Hospital Universitario Fundaciรณn Jimรฉnez Diaz
๐ช๐ธMadrid, Spain
VU University Medical Center
๐ณ๐ฑAmsterdam, Netherlands
Universitร Cattolica del Sacro Cuore (UNICATT)
๐ฎ๐นRome, Italy
Hospital MDACC
๐ช๐ธMadrid, Spain
Centre Hospitalier Universitaire Grenoble Alpes
๐ซ๐ทLa Tronche, France
Hospital San Pedro De Alcantra
๐ช๐ธCรกceres, Spain
University Health Network (UHN) - Princess Margaret Cancer Centre
๐จ๐ฆToronto, Ontario, Canada
Unitรฉ d'Evaluation Thรฉrapeutique en Onco-Hรฉmatologie (ETHO)
๐ซ๐ทMarseille, France
Fondazione Policlinico Tor Vergata, U.O.C. Ematologia
๐ฎ๐นRoma, Italy
Cardiff University School of Medicine
๐ฌ๐งCardiff, United Kingdom
Hospital Universitario de Salamanca
๐ช๐ธSalamanca, Spain
Institute of Hematology and Medical Oncology "L. and A. Serร gnoli"
๐ฎ๐นBologna, Italy
Ca' Foncello Hospital
๐ฎ๐นTreviso, Italy
Washington University School of Medicine
๐บ๐ธSaint Louis, Missouri, United States
Hospital Virgen de la Victoria, Mรกlaga
๐ช๐ธMรกlaga, Spain
University Hospital of Hospital Marquรฉs de Valdecilla
๐ช๐ธSantander, Spain
Memorial Sloan Kettering Cancer Center
๐บ๐ธNew York, New York, United States
Flinders Medical Centre
๐ฆ๐บBedford Park, South Australia, Australia
UC San Diego Moore Cancer Center
๐บ๐ธLa Jolla, California, United States
University of California Irvine
๐บ๐ธOrange, California, United States
Stanford Cancer Institute
๐บ๐ธPalo Alto, California, United States
Emory Winship Cancer Institute
๐บ๐ธAtlanta, Georgia, United States
Dana Farber Cancer Institute
๐บ๐ธBoston, Massachusetts, United States
Townsville Hospital
๐ฆ๐บDouglas, Queensland, Australia
Centre Hospitalier Universitaire d'Angers
๐ซ๐ทAngers, France
Sir Charles Gairdner Hospital
๐ฆ๐บNedlands, Perth, Australia
The Ohio State University Wexner Medical Center and James Cancer Hospital
๐บ๐ธColumbus, Ohio, United States
Juravinski Cancer Centre
๐จ๐ฆHamilton, Ontario, Canada
Calvary Mater Newcastle
๐ฆ๐บWaratah, New South Wales, Australia
CancerCare Manitoba
๐จ๐ฆWinnipeg, Manitoba, Canada
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
๐ฎ๐นMeldola, Italy
Centre Hospitalier Lyon Sud
๐ซ๐ทPierre-Bรฉnite, France
Hospital of Ravenna
๐ฎ๐นRavenna, Italy
University Medical Centre Utrecht
๐ณ๐ฑUtrecht, Netherlands
Hospital Universitari i Politรจcnic La Fe
๐ช๐ธValencia, Spain
University of California, Los Angeles - UCLA
๐บ๐ธLos Angeles, California, United States
Charles A. Sammons Cancer Center at Dallas
๐บ๐ธDallas, Texas, United States
Centre Hospitalier Universitaire de Bordeaux
๐ซ๐ทBordeaux, France
Centre Hospitalier Universitaire de Poitiers
๐ซ๐ทPoitiers, France
UC Davis Comprehensive Cancer Center
๐บ๐ธSacramento, California, United States
Vanderbilt-Ingram Cancer Center Clinical Trials Office
๐บ๐ธNashville, Tennessee, United States
Huntsman Cancer Institute, University of Utah
๐บ๐ธSalt Lake City, Utah, United States
University of Michigan
๐บ๐ธAnn Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute
๐บ๐ธDetroit, Michigan, United States
Duke University Health System (DUHS)
๐บ๐ธDurham, North Carolina, United States
Stephenson Cancer Center
๐บ๐ธOklahoma City, Oklahoma, United States
Wake Forest Baptist Hospital
๐บ๐ธWinston-Salem, North Carolina, United States
The University of Texas MD Anderson Cancer Center
๐บ๐ธHouston, Texas, United States