A Phase 1 interventional study of Uproleselan in Relapsed/Refractory AML, sponsored by Apollomics Inc.. Completed at 2 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by Apollomics Inc. · Phase 1, Interventional, and Treatment
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.
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).
2,971 studies on the registry are indexed under Leukemia, Myeloid, Acute; 745 are open to participants now.
This study's enrollment of 12 is below the median of 41 across 2,509 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →Apollomics Inc. is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
For refractory AML, only cytarabine/daunorubicin(or Idarubicin) as can be applied repeatedly(maximal twice) as induction, no other chemotherapy are allowed to be applied Venatoclax /hypomethylation drug [HMA] can be used before and after chemotherapy.
Exclusion Criteria:
Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC)
Drug: Uproleselan
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
Also known as: GMI-1271
Peak plasma concentration (Tmax)
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
Time frame: 14 days
Peak plasma concentration (Cmax)
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
Time frame: 14 days
Area under the plasma concentration-time curve from time zero to 12 hours (AUC0-12)
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
Time frame: 14 days
The area under the plasma concentration-time curve (AUC0-t) from time zero to the last measurable time point
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
Time frame: 14 days
The Incidence of Adverse Events
Number of participants with an AE.
Time frame: Up to 10 months
The tolerance of participants with relapsed/refractory AML.
Number of participants could tolerate the Uproleselan combined with chemotherapy.
Time frame: Up to 10 months
OS
Defined as the period from when the subject receives the first dose of the study drug to death from any cause;
Time frame: Up to 3 years
Remission rate (rate of CR, CR/CRi and CR/CRh)
Defined as the rate of subjects who reach CR, CR/CRi and CR/CRh;
Time frame: Up to 60 days
CTCAE grade 3 and 4 oral mucositis
The incidence of CTCAE grade 3 and 4 oral mucositis during the treatment duration.
Time frame: Up to 254 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Apollomics Inc.