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Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
Not Recruiting
Trial ID: NCT03616470
Purpose
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
Official Title
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
Stanford Investigator(s)
Gabriel Mannis
Associate Professor of Medicine (Hematology)
Eligibility
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.
Intervention(s):
drug: Uproleselan
drug: Placebo
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Amishi Jobanputra
650-723-8594