Trial Search Results

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

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

Stanford is currently accepting patients for this trial.

Lead Sponsor:

GlycoMimetics Incorporated

Stanford Investigator(s):

Intervention(s):

  • Drug: Uproleselan
  • Drug: Placebo

Phase:

Phase 3

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.

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amishi Jobanputra
650-723-8594
Recruiting