Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
Where in United States
- Ann Arbor · University of MichiganUnknown status
- Atlanta · Emory Winship Cancer InstituteUnknown status
- Atlanta · Northside Hospital - Medical TowerUnknown status
- Boston · Dana-Farber Cancer InstituteUnknown status
- Buffalo · Roswell Park Cancer InstituteUnknown status
- Chicago · Rush University Medical CenterUnknown status
- Cleveland · Cleveland ClinicUnknown status
- Cleveland · University Hospital Cleveland Medical CenterUnknown status
- Columbus · The Ohio State University Wexner Medical Center and James Cancer HospitalUnknown status
- Dallas · Charles A. Sammons Cancer Center at DallasUnknown status
- Detroit · Barbara Ann Karmanos Cancer InstituteUnknown status
- Durham · Duke University Health System (DUHS)Unknown status
- Hawthorne · Hudson Valley Cancer CenterUnknown status
- Houston · The University of Texas MD Anderson Cancer CenterUnknown status
- La Jolla · UC San Diego Moore Cancer CenterUnknown status
- Los Angeles · University of California Los Angeles (UCLA).Unknown status
- Nashville · Vanderbilt-Ingram Cancer Center Clinical Trials OfficeUnknown status
- New York · Columbia University / Herbert Irving Comprehensive Cancer CenterUnknown status
- New York · Memorial Sloan-Kettering Cancer CenterUnknown status
- New York · Weill Cornell Medical CollegeUnknown status
- Oklahoma City · Stephenson Cancer CenterUnknown status
- Orange · University of California IrvineUnknown status
- Palo Alto · Stanford Cancer InstituteUnknown status
- Rochester · University of Rochester Medical CenterUnknown status
- Sacramento · UC Davis Comprehensive Cancer CenterUnknown status
- Salt Lake City · Huntsman Cancer Institute/University of UtahUnknown status
- Seattle · Seattle Cancer Care AllianceUnknown status
- St Louis · Washington University School of MedicineUnknown status
- Westwood · The University of Kansas Cancer CenterUnknown status
- Winston-Salem · Wake Forest Baptist HospitalUnknown status
Also in 8 other countries, 40 sites
Spain 8, France 7, Italy 7, Australia 6, Canada 6, Netherlands 3, United Kingdom 2, Ireland 1.
The registry text, word for word
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
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
Inclusion: ≥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: 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; Major surgery within 4 weeks of dosing; Active signs or symptoms of CNS involvement by malignancy; Known active infection with hepatitis A, B, or C, or human immunodeficiency virus; Uncontrolled acute life-threatening bacterial, viral, or fungal infection; Clinically significant cardiovascular disease; Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML; Inadequate organ function; Abnormal liver function; Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).