NCT04839341

Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML Patients

A Phase I, Open-labeled Multicenter Study to Determine Pharmacokinetics, Safety, Tolerability and Efficacy of Uproleselan in Combination With Chemotherapy in Chinese Patients With Relapsed/Refractory Acute Myeloid Leukemia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Apollomics Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and tolerability of uproleselan(GMI-1271), a specific E-selectin antagonist, and characterize the pharmacokinetic (PK) profile of uproleselan, in combination with chemotherapy to treat Chinese relapsed/refractory AML patients.

Detailed description

This study is a multicenter open-labelled study conducted in subjects with relapsed or refractory AML in China. The study includes the following phases: screening phase, induction phase, consolidation phase baseline, consolidation phase and follow-up period. Screening phase: This study will enroll 12 subjects, who are 18 to 60 years (inclusive) at the time of signing the Informed Consent Form (ICF), and with the diagnosis as relapsed or refractory AML. Screening is conducted 21 days to 2 days before administration, and signed ICF by the subject must be obtained before screening. Baseline period: The baseline period is 1 day before study drug administration. Induction treatment: During the induction phase, subjects will receive 8 consecutive days of uproleselan treatment and 5 consecutive days of MEC (mitoxantrone, etoposide, and cytarabine combined regimen) chemotherapy. Consolidation baseline: The baseline of the consolidation phase is 1 day before the treatment administration of the consolidation phase. Consolidation treatment: Subjects who met the criteria for consolidation treatment started the consolidation period at the 29th day of the previous treatment cycle at the earliest and the 65th day at the latest. Follow-up period: Each subject should complete the following follow-up stage: (1) Response evaluation to determine remission to the induction treatment (induction period); (2) EOT assessment after completing the last consolidation treatment cycle; (3) Death. Survival and long-term follow-up, including initiation of new anti-leukemia treatment (within 6 months after the last uproleselan/placebo administration), recurrence, HSCT and survival events, monthly (±14 days) for 2 years after the end of treatment, and afterwards quarterly (±14 days). The longest survival follow-up time is 3 years (calculated from the start of treatment).

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

Timeline

• Start date: 2021-02-24
• Primary completion: 2024-06-28
• Completion: 2024-06-28
• First posted: 2021-04-09
• Last updated: 2025-06-27

Locations

2 sites across 1 country: China