Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia

July 26, 2024 updated by: GlycoMimetics Incorporated

A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered With Chemotherapy Versus Chemotherapy Alone in Patients With Relapsed/Refractory Acute Myeloid Leukemia

This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be investigated in patients with relapsed/refractory AML

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
388

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Waratah, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
    • Perth
      • Nedlands, Perth, Australia, 6009
        • Sir Charles Gairdner Hospital
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Townsville Hospital
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Cancer Clinical Trials Centre (CCTC)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Tom Baker Cancer Center
      • Edmonton, Alberta, Canada
        • University of Alberta Princess Margaret Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada
        • The Leukemia/BMT Program of BC Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E0V9
        • CancerCare Manitoba
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Juravinski Cancer Centre
      • Toronto, Ontario, Canada, M5G 2MG
        • University Health Network (UHN) - Princess Margaret Cancer Centre
  • France
      • Angers, France, 49933
        • Centre Hospitalier Universitaire d'Angers
      • Bordeaux, France, 33604
        • Centre Hospitalier Universitaire De Bordeaux
      • La Tronche, France, 38700
        • Centre Hospitalier Universitaire Grenoble Alpes
      • Marseille, France, 13273
        • Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO)
      • Paris, France, 75010
        • Saint-Louis Hospital
      • Pierre-Bénite, France, 75010
        • Centre Hospitalier LYON SUD
      • Poitiers, France, 86021
        • Centre Hospitalier Universitaire de Poitiers
  • Ireland
      • Galway, Ireland, H91 TK33
        • Galway University Hospital
  • Italy
      • Bologna, Italy, 40138
        • Institute of Hematology and Medical Oncology "L. and A. Seragnoli"
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
      • Ravenna, Italy, 48121
        • Hospital of Ravenna
      • Roma, Italy, 00133
        • Fondazione Policlinico Tor Vergata, U.O.C. Ematologia
      • Rome, Italy, 00168
        • Università Cattolica del Sacro Cuore (UNICATT)
      • Treviso, Italy, 31100
        • Ca' Foncello Hospital
    • FG
      • San Giovanni Rotondo, FG, Italy
        • IRCCS Casa Sollievo della Sofferenza Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU University Medical Center
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen
      • Utrecht, Netherlands, 3584
        • University Medical Centre Utrecht
  • Spain
      • Cáceres, Spain, 10003
        • Hospital San Pedro De Alcantra
      • Madrid, Spain, 28040
        • Hospital Universitario Fundación Jiménez Díaz
      • Madrid, Spain, 28033
        • Hospital MDACC
      • Málaga, Spain, 29010
        • Hospital Virgen de la Victoria, Málaga
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
      • Salamanca, Spain, 37007
        • Hospital Universitario De Salamanca
      • Santander, Spain, 39008
        • University Hospital of Hospital Marqués de Valdecilla
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XN
        • Cardiff University School of Medicine
    • England
      • Oxford, England, United Kingdom, OX3 7LJ
        • Radcliffe Hospitals and University of Oxford
  • United States
    • California
      • La Jolla, California, United States, 92093
        • UC San Diego Moore Cancer Center
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles - UCLA
      • Orange, California, United States, 92868
        • University of California Irvine
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Institute
      • Sacramento, California, United States, 95817
        • UC Davis Comprehensive Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Winship Cancer Institute
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital - Medical Tower
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
    • Kansas
      • Westwood, Kansas, United States, 66205
        • The University of Kansas Cancer Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Barbara Ann Karmanos Cancer Institute
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • Hawthorne, New York, United States, 10532
        • Hudson Valley Cancer Center
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10032
        • Columbia University Herbert Irving Comprehensive Cancer Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Health System (DUHS)
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Hospital
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospital Cleveland Medical Center
      • Columbus, Ohio, United States, 43210
        • The Ohio State University Wexner Medical Center and James Cancer Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Stephenson Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt-Ingram Cancer Center Clinical Trials Office
    • Texas
      • Dallas, Texas, United States, 75246
        • Charles A. Sammons Cancer Center at Dallas
      • Houston, Texas, United States, 77030
        • The University of Texas MD Anderson Cancer Center
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Huntsman Cancer Institute, University of Utah
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥18 years and ≤75 years in age
  • Patients with relapsed or refractory AML
  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Uproleselan (GMI-1271)
Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
Drug: Uproleselan
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
Placebo Comparator: Placebo (Saline, 0.9% Sodium Chloride)
Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
Drug: Placebo
Saline, 0.9% Sodium Chloride

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 5 years
Time from the date of randomization into the study to the date of death.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of severe oral mucositis
Time Frame: up to 60 days
Incidence of severe oral mucositis experienced in patients after treatment.
up to 60 days
Overall response rate
Time Frame: Up to 60 days
Proportion of subjects who achieve a complete remission [CR] or CR with partial recovery [CRh] of blood counts
Up to 60 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: up to 5 months
Frequency, severity, and relatedness of adverse events.
up to 5 months
Pharmacokinetic exposure (amount of uproleselan in the blood)
Time Frame: up to 6 days
The amount of uproleselan in the blood over time.
up to 6 days
Event-free survival
Time Frame: 5 years
Time from date of randomization into the study to the date of treatment failure, relapse, or death from any cause; whichever occurs first.
5 years
Duration of remission
Time Frame: 5 years
Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first.
5 years
Event-free survival
Time Frame: 1 year
Landmark analysis: Time from date of randomization into the study to the date of relapse or death from any cause; whichever occurs first.
1 year
Overall survival
Time Frame: 2 years
Landmark analysis: Time from the date of randomization into the study to the date of death.
2 years
Overall survival
Time Frame: 3 years
Landmark analysis: Time from the date of randomization into the study to the date of death.
3 years
Overall survival
Time Frame: 4 years
Landmark analysis: Time from the date of randomization into the study to the date of death.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlycoMimetics Incorporated

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel J DeAngelo, MD, PhD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GMI-1271-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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