For Healthcare Professionals

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

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About the study

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
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. ≥18 years and ≤75 years in age
  2. Patients with relapsed or refractory AML
  3. No more than one prior stem cell transplant
  4. Has not received the chemotherapy regimen to be used for induction on this trial
  5. Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial

EXCLUSION CRITERIA

  1. Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML.
  2. Active signs or symptoms of CNS involvement by malignancy.
  3. Stem cell transplantation ≤4 months prior to dosing.
  4. Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing.
  5. Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.
  6. Inadequate organ function.
  7. Abnormal liver function.
  8. Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.
  9. Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).
  10. Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
  11. Clinically significant cardiovascular disease.
  12. Major surgery within 4 weeks of dosing.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 240-243-1201Email iconEmail Study Center

Study’s details


Contition

Acute Myeloid Leukemia

Age (in years)

18 - 75

Phase

Phase 3

Participants needed

388

Est. Completion Date

Dec 2023

Treatment type

Interventional


Sponsor

GlycoMimetics Incorporated

ClinicalTrials.gov identifier

NCT03616470

Study number

GMI-1271-301

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