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 not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: Uproleselan
  • drug: Placebo

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

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amishi Jobanputra
650-723-8594
Not Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.