Study to Evaluate the Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With R/R AML

This trial will enroll approximately 140 randomized subjects 18 through 75 years of age at the time of randomization with primary refractory AML or relapsed AML (first or second untreated relapse) and eligible to receive induction chemotherapy as described.

Randomization will be done at trial entry at a 1:1 ratio, and will be stratified by age (\<60, ≥60 years) and disease status (primary refractory/early relapse ≤6 months, late relapse\>6 months) and prior HSCT status. Treatment assignment received at randomization will be maintained during all induction and consolidation cycles.

This trial will have the following sequential phases: screening, baseline, induction treatment and count recovery, response assessment, consolidation treatment (if remission is achieved), and follow-up for relapse and survival assessment. Subjects not achieving remission will continue to be followed for long-term trial endpoints such as disease progression and survival. Blinding will be maintained until database lock. This study will carry out long-term follow-up for all subjects for a maximum of 3 years or death of subjects or withdrawal of consent.