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

NCT05054543 | Terminated Phase 3 DMC

• 1 other identifier: APL-106-02
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Relapsed/Refractory AML

Keywords

AML

Outcome Measures

Primary Outcomes (1)

• Overall survival

  Time from the date of randomization into the study to the date of death.

  3 years

Secondary Outcomes (4)

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

  Up to 60 days

• Duration of remission

  Up to 3 years

• Event-free survival

  Up to 3 years

• Rate of severe oral mucositis

  Up to 254 days

Study Arms (2)

Uproleselan

EXPERIMENTAL

Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) during induction; Uproleselan in combination with HiDAC/IDAC during consolidation

Drug: Uproleselan

Placebo (Saline, 0.9% Sodium Chloride)

PLACEBO COMPARATOR

Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) during induction; Placebo in combination with HiDAC/IDAC during consolidation

Drug: Placebo

Interventions

Uproleselan DRUG

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

Also known as: GMI-1271

Uproleselan

Placebo DRUG

0.9% Sodium Chloride

Also known as: Saline

Placebo (Saline, 0.9% Sodium Chloride)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years and ≤75 years in age
• AML diagnosed with ≥20% myeloid marrow blasts or peripheral blood blasts per WHO criteria(2008) at the time of initial diagnosis
• For subjects with primary refractory AML:
• Refractory disease is defined as persistent disease (≥5% blasts in the bone marrow) at least 28 days after initiation of anthracycline-containing induction therapy or relapse from a first remission (CR, CRi, complete remission with incomplete platelet recovery \[CRp\], CRh) lasting for \<90 days. Isolated extramedullary disease is not allowed.
• Persistent disease (≥5% blasts in the bone marrow): Must have received 1 (and only 1) prior anthracycline-containing induction regimen. Except as defined below, a second induction with intent to induce remission is not allowed.
• Re-induction within 28 days with a comparable regimen containing the same chemotherapy agents (e.g., cytarabine/daunorubicin '7+3' and '5+2'; or cytarabine/daunorubicin '7+3' and '7+3') is allowed.
• Re-induction within 28 days with a comparable regimen using an alternative anthracycline (e.g., cytarabine/daunorubicin in the first induction and cytarabine/idarubicin in the second) is allowed.
• Previous induction with certain regimens (venetoclax/hypomethylating agent \[HMA\], venetoclax/LDAC, single agent HMA) followed by an anthracycline induction regimen is allowed. May have achieved remission with certain regimens (venetoclax/HMA, venetoclax/LDAC, single agent HMA) and then experience relapse now refractory to anthracycline-containing induction.
• Relapse from first remission (CR, CRi, CRp, CRh) lasting \<90 days: 1) After achieving first remission from any induction regimen, may have received consolidation before experiencing relapse.
• No more than one prior stem cell transplant.
• Has not received the chemotherapy regimen to be used for induction on this trial.
• Is considered medically eligible to receive the chemotherapy regimen to be used for induction on this trial.
• Peripheral absolute blast count (ABC) ≤40.0 x 109/L (ABC = total white blood cells \[WBC\] x blast % in peripheral blood). Hydroxyurea to control absolute blast count is allowed prior to uproleselan/placebo dosing.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

You may not qualify if:

• Patients with acute promyelocytic leukemia
• Acute leukemia of ambiguous lineage (biphenotypic leukemia)
• Chronic myeloid leukemia with myeloid blast crisis
• Active signs or symptoms of CNS involvement by malignancy (No lumbar puncture required)
• Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.
• Allogeneic HSCT ≤ 4 months, autologous HSCT ≤ 3 months or donor lymphocyte infusion (DLI) ≤ 6 weeks prior to Uproleselan/placebo dosing.
• Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other experimental therapy or chemotherapy within 14 days of dosing
• Inadequate organ function.
• Abnormal liver function.
• Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.
• Creatinine clearance \<45 mL/min (Cockcroft-Gault method) or creatinine \>1.5x ULN (any assessed must be within eligibility limit).
• Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
• Myocardial infarction within 6 months of uproleselan/placebo dosing, or subject has current significant cardiovascular disease.
• Major surgery within 4 weeks before uproleselan/placebo 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; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 23, 2021
• Study Start: November 17, 2021
• Primary Completion: August 22, 2024
• Study Completion: August 22, 2024
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)