Acute Myeloid LeukemiaPhase 3NCT03616470
Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
A Phase 3 study testing Uproleselan in people with Acute Myeloid Leukemia, run by GlycoMimetics Incorporated at 70 sites in 9 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Uproleselan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 70 sitesin 9 countries
- Study dates
- 15 Oct 2018to 31 Mar 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
- 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
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
70 sites in 9 countries.
70 sites in 9 countries
United States30 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Northside Hospital - Medical Tower
Atlanta, Georgia, 30342
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Roswell Park Cancer Institute
Buffalo, New York, 14263
Rush University Medical Center
Chicago, Illinois, 60612
University Hospital Cleveland Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
The Ohio State University Wexner Medical Center and James Cancer Hospital
Columbus, Ohio, 43210
Charles A. Sammons Cancer Center at Dallas
Dallas, Texas, 75246
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
Duke University Health System (DUHS)
Durham, North Carolina, 27710
Hudson Valley Cancer Center
Hawthorne, New York, 10532
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
UC San Diego Moore Cancer Center
La Jolla, California, 92093
University of California, Los Angeles - UCLA
Los Angeles, California, 90095
Vanderbilt-Ingram Cancer Center Clinical Trials Office
Nashville, Tennessee, 37203
Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical College
New York, New York, 10065
Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
University of California Irvine
Orange, California, 92868
Stanford Cancer Institute
Palo Alto, California, 94304
University of Rochester Medical Center
Rochester, New York, 14642
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Seattle Cancer Care Alliance
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
The University of Kansas Cancer Center
Westwood, Kansas, 66205
Wake Forest Baptist Hospital
Winston-Salem, North Carolina, 27157
Spain8 sites
Hospital San Pedro De Alcantra
Cáceres, 10003
Hospital MDACC
Madrid, 28033
Hospital Universitario Fundación Jiménez Diaz
Madrid, 28040
Hospital Virgen de la Victoria, Málaga
Málaga, 29010
Clínica Universidad de Navarra
Pamplona, 31008
Hospital Universitario de Salamanca
Salamanca, 37007
University Hospital of Hospital Marqués de Valdecilla
Santander, 39008
Hospital Universitari i Politècnic La Fe
Valencia, 46026
France7 sites
Centre Hospitalier Universitaire d'Angers
Angers, 49933
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, 33604
Centre Hospitalier Universitaire Grenoble Alpes
La Tronche, 38700
Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO)
Marseille, 13273
Saint-Louis Hospital
Paris, 75010
Centre Hospitalier Lyon Sud
Pierre-Bénite, 75010
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021
Italy7 sites
Institute of Hematology and Medical Oncology "L. and A. Seràgnoli"
Bologna, 40138
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, 47014
Hospital of Ravenna
Ravenna, 48121
Fondazione Policlinico Tor Vergata, U.O.C. Ematologia
Roma, 00133
Università Cattolica del Sacro Cuore (UNICATT)
Rome, 00168
IRCCS Casa Sollievo della Sofferenza Hospital
San Giovanni Rotondo, FG
Ca' Foncello Hospital
Treviso, 31100
Australia6 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Townsville Hospital
Douglas, Queensland, 4814
Cancer Clinical Trials Centre (CCTC)
Heidelberg, Victoria, 3084
Sir Charles Gairdner Hospital
Nedlands, Perth, 6009
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Canada6 sites
Tom Baker Cancer Center
Calgary, Alberta, T2N 4N2
University of Alberta Princess Margaret Hospital
Edmonton, Alberta
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
University Health Network (UHN) - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2MG
The Leukemia/BMT Program of BC Vancouver General Hospital
Vancouver, British Columbia
CancerCare Manitoba
Winnipeg, Manitoba, R3E0V9
Netherlands3 sites
VU University Medical Center
Amsterdam, 1081 HV
University Medical Center Groningen
Groningen, 9713 GZ
University Medical Centre Utrecht
Utrecht, 3584
United Kingdom2 sites
Cardiff University School of Medicine
Cardiff, CF14 4XN
Radcliffe Hospitals and University of Oxford
Oxford, England, OX3 7LJ
About this study
Official title: 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
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Uproleselan, Placebo
- Keywords
- acute myeloid leukemia, AML, Relapsed AML, Refractory 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
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
PlaceboDrug
Saline, 0.9% Sodium Chloride
| Study group | Role | What they receive |
|---|---|---|
| Uproleselan (GMI-1271) | Experimental | Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI) Receives: Drug: Uproleselan |
| Placebo (Saline, 0.9% Sodium Chloride) | Placebo comparator | Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from the date of randomization into the study to the date of death.
Measured: 5 years
Secondary outcomes (2)
Rate of severe oral mucositis
Incidence of severe oral mucositis experienced in patients after treatment.
Measured: up to 60 days
Overall response rate
Proportion of subjects who achieve a complete remission [CR] or CR with partial recovery [CRh] of blood counts
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start15 Oct 2018
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Why it stopped: Trial failed to meet primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 388 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoMimetics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel J DeAngelo, MD, PhD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616470
- Sponsor's protocol ID
- GMI-1271-301
- Status last verified
- Jul 2024
- First submitted
- 26 Jul 2018
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03616470
- Acronym / sponsor ID
- GMI-1271-301
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia, AML, Relapsed AML, Refractory AML
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial failed to meet primary endpoint.
- Enrolment
- 388 participants (actual)
- Lead sponsor
- GlycoMimetics IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 6 Aug 2018 (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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uproleselan (GMI-1271) | Experimental | Drug: UproleselanUproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI) |
| Placebo (Saline, 0.9% Sodium Chloride) | Placebo comparator | Drug: PlaceboPlacebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥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
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 |
|---|---|---|
| UproleselanA rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin | Drug | Uproleselan (GMI-1271) |
| PlaceboSaline, 0.9% Sodium Chloride | Drug | Placebo (Saline, 0.9% Sodium Chloride) |
Primary outcome
Overall survival
Time frame: 5 years
Time from the date of randomization into the study to the date of death.
2 secondary outcomes
Rate of severe oral mucositis
Time frame: up to 60 days
Overall response rate
Time frame: Up to 60 days
Results and safety
The study was stopped early (reason given: Trial failed to meet primary endpoint.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
Related trials for Acute Myeloid Leukemia
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Daniel J DeAngelo, MD, PhD principal investigator
Dana-Farber Cancer Institute
70 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Uproleselan in people with Acute Myeloid Leukemia, run by GlycoMimetics Incorporated at 70 sites in 9 countries.
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 5 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: stopped early, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 70 sites in United States, Spain, France, Italy, Australia and 4 more countries. 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: Trial failed to meet primary endpoint.). 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: 5 years). 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 29 Jul 2024.