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


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
Gabriel Mannis

Associate Professor of Medicine (Hematology)


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.


drug: Uproleselan

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amishi Jobanputra

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