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Relapsed/Refractory AMLPhase 3NCT05054543

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

A Phase 3 study testing Uproleselan in people with Relapsed/Refractory AML, run by Apollomics Inc. at 2 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Relapsed/Refractory AML
What is being tested?
Uproleselan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
140 participants
Where
2 sitesChina
Study dates
17 Nov 2021to 22 Aug 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The First Affiliated Hospital of Zhejiang University

    Hangzhou

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

    Tianjin, Tianjin Municipality, 300020

Other trials in China

About this study

Official title: 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

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

Read the 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.

Being tested
Uproleselan, Placebo
Keywords
AML
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UproleselanDrug

    Also called GMI-1271

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

  • PlaceboDrug

    Also called Saline

    0.9% Sodium Chloride

Study groups in NCT05054543
Study groupRoleWhat they receive
UproleselanExperimentalUproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) during induction; Uproleselan in combination with HiDAC/IDAC during consolidation
Receives: Drug: Uproleselan
Placebo (Saline, 0.9% Sodium Chloride)Placebo comparatorPlacebo in combination with mitoxantrone, etoposide and cytarabine (MEC) during induction; Placebo in combination with HiDAC/IDAC during consolidation
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

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

    Measured: 3 years

Secondary outcomes (4)

  1. Remission rate(rate of CR, CR/CRi and CR/CRh)

    Defined as the rate of subjects who reach CR, CR/CRi and CR/CRh

    Measured: Up to 60 days

  2. Duration of remission

    Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first.

    Measured: Up to 3 years

  3. Event-free survival

    Time from date of randomization into the study to the date of treatment failure, relapse, or death from any cause; whichever occurs first.

    Measured: Up to 3 years

  4. Rate of severe oral mucositis

    Incidence of severe oral mucositis experienced in patients after treatment.

    Measured: Up to 254 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2021
  2. Study start17 Nov 2021
  3. Primary completion22 Aug 2024
  4. Study completion22 Aug 2024

Why it stopped: In light of the strategic realignment of the company's development focus, it has been determined to discontinue the further development of Uproleselan Injection.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05054543
Sponsor's protocol ID
APL-106-02
Status last verified
Jun 2025
First submitted
14 Sep 2021
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Uproleselan in people with Relapsed/Refractory AML, run by Apollomics Inc. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: In light of the strategic realignment of the company's development focus, it has been determined to discontinue the further development of Uproleselan Injection.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05054543.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.

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