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

NCT04839341 | Completed Phase 1

• 1 other identifier: APL-106-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Relapsed/Refractory AML

Keywords

AML

Outcome Measures

Primary Outcomes (6)

• Peak plasma concentration (Tmax)

  To assess the pharmacokinetic profile in patients with relapsed/refractory AML.

  14 days

• Peak plasma concentration (Cmax)

  To assess the pharmacokinetic profile in patients with relapsed/refractory AML.

  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.

  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.

  14 days

• The Incidence of Adverse Events

  Number of participants with an AE.

  Up to 10 months

• The tolerance of participants with relapsed/refractory AML.

  Number of participants could tolerate the Uproleselan combined with chemotherapy.

  Up to 10 months

Secondary Outcomes (3)

• OS

  Up to 3 years

• Remission rate (rate of CR, CR/CRi and CR/CRh)

  Up to 60 days

• CTCAE grade 3 and 4 oral mucositis

  Up to 254 days

Study Arms (1)

A Phase I, open-labeled multicenter study

EXPERIMENTAL

Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC)

Drug: Uproleselan

Interventions

Uproleselan DRUG

A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin

Also known as: GMI-1271

A Phase I, open-labeled multicenter study

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ≥18 years and ≤60 years in age
• AML (including secondary AML) diagnosed as per WHO standards (2008).
• 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.
• For relapse AML, it must be the first or second relapse, and remain untreated.
• Certain regimens (Venatoclax/HMA, Venetoclax/LDAC, HMA single agent) and FLT3 inhibitors, tyrosine kinase inhibitors, IDH1/IDH2 inhibitors or similar targeted inhibitors used alone are not considered cytotoxic chemotherapy are allowed.
• ECOG performance status score is 0 to 2.
• Stable hemodynamics and good organ function.

You may not qualify if:

• Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage (biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or secondary refractory AML.
• Active signs or symptoms of CNS involvement by malignancy.
• Stem cell transplantation ≤4 months prior to dosing.
• Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing.
• Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.
• Inadequate organ function.
• Abnormal liver function.
• Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.
• Moderate kidney dysfunction (glomerular filtration rate \<45 mL/min).
• Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
• Clinically significant cardiovascular disease.
• Major surgery within 4 weeks of dosing.

Sponsors & Collaborators

• Apollomics Inc.: lead

Study Sites (2)

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Tianjin, Tianjin Municipality, 300020, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

uproleselan

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Jianxiang Wang, PhD

  Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 9, 2021
• Study Start: February 24, 2021
• Primary Completion: June 28, 2024
• Study Completion: June 28, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)