Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
Trial ID or NCT#
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
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
- - ≥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.
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