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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
388
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
Saline, 0.9% Sodium Chloride
Overall survival
Time from the date of randomization into the study to the date of death.
Time frame: 5 years
Rate of severe oral mucositis
Incidence of severe oral mucositis experienced in patients after treatment.
Time frame: up to 60 days
Overall response rate
Proportion of subjects who achieve a complete remission \[CR\] or CR with partial recovery \[CRh\] of blood counts
Time frame: Up to 60 days
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