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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Acute Myeloid Leukemia

In brief

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

Key facts

Study ID

NCT03616470

Run by

GlycoMimetics Incorporated

People needed

388

Starts

2018-10-15

Expected to finish

2024-03-31

Last updated by the study team

2024-07-29

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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.

Where it is running

• 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
• UC San Diego Moore Cancer Center — La Jolla, California, United States

Full record on ClinicalTrials.gov

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