NCT05054543

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

A Phase 3 Randomized, Double-Blinded Bridging Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Chinese Patients With Relapsed/Refractory Acute Myeloid Leukemia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Apollomics Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This bridging study will evaluate the efficacy of uproleselan, a specific E-selectin antagonist, in combination with chemotherapy to treat Chinese relapsed/refractory AML patients, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML

Detailed description

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.

Conditions

• Relapsed/Refractory AML

Interventions

Type	Name	Description
DRUG	Uproleselan	A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
DRUG	Placebo	0.9% Sodium Chloride

Timeline

• Start date: 2021-11-17
• Primary completion: 2024-08-22
• Completion: 2024-08-22
• First posted: 2021-09-23
• Last updated: 2025-06-27

Locations

2 sites across 1 country: China