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.
- Drug: Uproleselan
- Drug: Placebo
- ≥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
- 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