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

Trial Status: Active

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 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.

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: IN_REVIEW
Contact: Bruck Habtemariam
Phone: 310-794-0242
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
Sacramento
University of California Davis Comprehensive Cancer Center
Status: ACTIVE
San Diego
University of California San Diego
Status: ACTIVE

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL

Massachusetts

Boston
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ACTIVE

New York

Buffalo
Roswell Park Cancer Institute
Status: ACTIVE
New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Martin S. Tallman
Phone: 646-608-2122

North Carolina

Durham
Duke University Medical Center
Status: ACTIVE
Winston-Salem
Wake Forest University Health Sciences
Status: APPROVED

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: ACTIVE
Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
GlycoMimetics Incorporated

  • Primary ID GMI-1271-301
  • Secondary IDs NCI-2018-02198
  • Clinicaltrials.gov ID NCT03616470