Relapsed/Refractory AMLPhase 1NCT04839341
Study to Evaluate PK and Safety With Uproleselan Combined With Chemotherapy to Treat Chinese R/R AML Patients
A Phase 1 study testing Uproleselan in people with Relapsed/Refractory AML, run by Apollomics Inc. at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsed/Refractory AML
- What is being tested?
- Uproleselan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChina
- Study dates
- 24 Feb 2021to 28 Jun 2024
- Phase
- Phase 1
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
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
About this study
Official title: 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
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.
Read the 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
- Being tested
- Uproleselan
- 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
| Study group | Role | What they receive |
|---|---|---|
| A Phase I, open-labeled multicenter study | Experimental | Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) Receives: Drug: Uproleselan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration (Tmax)
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
Measured: 14 days
Peak plasma concentration (Cmax)
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
Measured: 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.
Measured: 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.
Measured: 14 days
The Incidence of Adverse Events
Number of participants with an AE.
Measured: Up to 10 months
The tolerance of participants with relapsed/refractory AML.
Number of participants could tolerate the Uproleselan combined with chemotherapy.
Measured: Up to 10 months
Secondary outcomes (3)
OS
Defined as the period from when the subject receives the first dose of the study drug to death from any cause;
Measured: 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;
Measured: 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.
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.
- First posted9 Apr 2021
- Study start24 Feb 2021
- Primary completion28 Jun 2024
- Study completion28 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed/Refractory AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apollomics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianxiang Wang, PhD, Principal investigator, Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839341
- Sponsor's protocol ID
- APL-106-01
- Status last verified
- Jun 2025
- First submitted
- 22 Mar 2021
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04839341
- Acronym / sponsor ID
- APL-106-01
- Conditions
- Relapsed/Refractory AML
- Keywords
- AML
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Apollomics Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Jun 2024 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A Phase I, open-labeled multicenter study | Experimental | Drug: UproleselanUproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- ≥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.
- ECOG performance status score is 0 to 2.
- Stable hemodynamics and good organ function.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UproleselanAlso: GMI-1271A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin | Drug | A Phase I, open-labeled multicenter study |
Primary outcome
Peak plasma concentration (Tmax)
Time frame: 14 days
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
Peak plasma concentration (Cmax)
Time frame: 14 days
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
Area under the plasma concentration-time curve from time zero to 12 hours (AUC0-12)
Time frame: 14 days
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
The area under the plasma concentration-time curve (AUC0-t) from time zero to the last measurable time point
Time frame: 14 days
To assess the pharmacokinetic profile in patients with relapsed/refractory AML.
The Incidence of Adverse Events
Time frame: Up to 10 months
Number of participants with an AE.
The tolerance of participants with relapsed/refractory AML.
Time frame: Up to 10 months
Number of participants could tolerate the Uproleselan combined with chemotherapy.
3 secondary outcomes
OS
Time frame: Up to 3 years
Remission rate (rate of CR, CR/CRi and CR/CRh)
Time frame: Up to 60 days
CTCAE grade 3 and 4 oral mucositis
Time frame: Up to 254 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Relapsed/Refractory AML
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Active, not recruitingPhase 3
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia
RecruitingPhase 1
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
R/R AML, R/R HR-MDS
RecruitingPhase 2
Olutasidenib in Relapsed IDH1 Mutated AML Patients Who Have Previously Received Venetoclax
IDH1 Mutation, Relapsed / Refractory AML
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianxiang Wang, PhD principal investigator
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 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 7 inclusion and 12 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: finished, 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Peak plasma concentration (Tmax) (time frame: 14 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.