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

Primary Purpose

Acute Myeloid Leukemia

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Uproleselan
Placebo
Sponsored by
GlycoMimetics Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring acute myeloid leukemia, AML, Relapsed AML, Refractory AML

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UC San Diego Moore Cancer Center
  • University of California, Los Angeles - UCLA
  • University of California Irvine
  • Stanford Cancer Institute
  • UC Davis Comprehensive Cancer Center
  • Emory Winship Cancer Institute
  • Northside Hospital - Medical Tower
  • Rush University Medical Center
  • The University of Kansas Cancer Center
  • Dana Farber Cancer Institute
  • University of Michigan
  • Barbara Ann Karmanos Cancer Institute
  • Washington University School of Medicine
  • Roswell Park Cancer Institute
  • Hudson Valley Cancer Center
  • Columbia University Herbert Irving Comprehensive Cancer Center
  • Memorial Sloan Kettering Cancer Center
  • Weill Cornell Medical College
  • University of Rochester Medical Center
  • Duke University Health System (DUHS)
  • Wake Forest Baptist Hospital
  • University Hospital Cleveland Medical Center
  • Cleveland Clinic
  • The Ohio State University Wexner Medical Center and James Cancer Hospital
  • Stephenson Cancer Center
  • Vanderbilt-Ingram Cancer Center Clinical Trials Office
  • Charles A. Sammons Cancer Center at Dallas
  • The University of Texas MD Anderson Cancer Center
  • Huntsman Cancer Institute, University of Utah
  • Seattle Cancer Care Alliance
  • Calvary Mater Newcastle
  • Sir Charles Gairdner Hospital
  • Townsville Hospital
  • Princess Alexandra Hospital
  • Flinders Medical Centre
  • Cancer Clinical Trials Centre (CCTC)
  • Tom Baker Cancer Center
  • University of Alberta Princess Margaret Hospital
  • The Leukemia/BMT Program of BC Vancouver General Hospital
  • CancerCare Manitoba
  • Juravinski Cancer Centre
  • University Health Network (UHN) - Princess Margaret Cancer Centre
  • Centre Hospitalier Universitaire d'Angers
  • Centre Hospitalier Universitaire de Bordeaux
  • Centre Hospitalier Universitaire Grenoble Alpes
  • Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO)
  • Saint-Louis Hospital
  • Centre Hospitalier Lyon Sud
  • Centre Hospitalier Universitaire de Poitiers
  • Galway University Hospital
  • IRCCS Casa Sollievo della Sofferenza Hospital
  • Institute of Hematology and Medical Oncology "L. and A. Seràgnoli"
  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
  • Hospital of Ravenna
  • Fondazione Policlinico Tor Vergata, U.O.C. Ematologia
  • Università Cattolica del Sacro Cuore (UNICATT)
  • Ca' Foncello Hospital
  • VU University Medical Center
  • University Medical Center Groningen
  • University Medical Centre Utrecht
  • Hospital San Pedro De Alcantra
  • Hospital MDACC
  • Hospital Universitario Fundación Jiménez Diaz
  • Hospital Virgen de la Victoria, Málaga
  • Clínica Universidad de Navarra
  • Hospital Universitario de Salamanca
  • University Hospital of Hospital Marqués de Valdecilla
  • Hospital Universitari i Politècnic La Fe
  • Radcliffe Hospitals and University of Oxford
  • Cardiff University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Uproleselan (GMI-1271)

Placebo (Saline, 0.9% Sodium Chloride)

Arm Description

Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)

Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Rate of severe oral mucositis
Incidence of severe oral mucositis experienced in patients after treatment.
Overall response rate
Proportion of subjects who achieve a complete remission [CR] or CR with partial recovery [CRh] of blood counts

Full Information

First Posted
July 26, 2018
Last Updated
July 21, 2023
Sponsor
GlycoMimetics Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT03616470
Brief Title
Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlycoMimetics Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
acute myeloid leukemia, AML, Relapsed AML, Refractory AML

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Uproleselan (GMI-1271)
Arm Type
Experimental
Arm Description
Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
Arm Title
Placebo (Saline, 0.9% Sodium Chloride)
Arm Type
Placebo Comparator
Arm Description
Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
Intervention Type
Drug
Intervention Name(s)
Uproleselan
Intervention Description
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Saline, 0.9% Sodium Chloride
Primary Outcome Measure Information:
Title
Overall survival
Description
Time from the date of randomization into the study to the date of death.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Rate of severe oral mucositis
Description
Incidence of severe oral mucositis experienced in patients after treatment.
Time Frame
up to 60 days
Title
Overall response rate
Description
Proportion of subjects who achieve a complete remission [CR] or CR with partial recovery [CRh] of blood counts
Time Frame
Up to 60 days
Other Pre-specified Outcome Measures:
Title
Event-free survival
Description
Time from date of randomization into the study to the date of treatment failure, relapse, or death from any cause; whichever occurs first.
Time Frame
5 years
Title
Duration of remission
Description
Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first.
Time Frame
5 years
Title
Adverse events
Description
Frequency, severity, and relatedness of adverse events.
Time Frame
up to 5 months
Title
Pharmacokinetic exposure (amount of uproleselan in the blood)
Description
The amount of uproleselan in the blood over time.
Time Frame
up to 6 days
Title
Event-free survival
Description
Landmark analysis: Time from date of randomization into the study to the date of relapse or death from any cause; whichever occurs first.
Time Frame
1 year
Title
Overall survival
Description
Landmark analysis: Time from the date of randomization into the study to the date of death.
Time Frame
2 years
Title
Overall survival
Description
Landmark analysis: Time from the date of randomization into the study to the date of death.
Time Frame
3 years
Title
Overall survival
Description
Landmark analysis: Time from the date of randomization into the study to the date of death.
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel J DeAngelo, MD, PhD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego Moore Cancer Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California, Los Angeles - UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Stanford Cancer Institute
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
UC Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Emory Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northside Hospital - Medical Tower
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Hudson Valley Cancer Center
City
Hawthorne
State/Province
New York
ZIP/Postal Code
10532
Country
United States
Facility Name
Columbia University Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Health System (DUHS)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest Baptist Hospital
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospital Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
The Ohio State University Wexner Medical Center and James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center Clinical Trials Office
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Charles A. Sammons Cancer Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
The University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Huntsman Cancer Institute, University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Seattle Cancer Care Alliance
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Calvary Mater Newcastle
City
Waratah
State/Province
New South Wales
ZIP/Postal Code
2298
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Perth
ZIP/Postal Code
6009
Country
Australia
Facility Name
Townsville Hospital
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4814
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Flinders Medical Centre
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Cancer Clinical Trials Centre (CCTC)
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Tom Baker Cancer Center
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
University of Alberta Princess Margaret Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
The Leukemia/BMT Program of BC Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E0V9
Country
Canada
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
University Health Network (UHN) - Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2MG
Country
Canada
Facility Name
Centre Hospitalier Universitaire d'Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Bordeaux
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Universitaire Grenoble Alpes
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO)
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Saint-Louis Hospital
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre-Bénite
ZIP/Postal Code
75010
Country
France
Facility Name
Centre Hospitalier Universitaire de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Galway University Hospital
City
Galway
ZIP/Postal Code
H91 TK33
Country
Ireland
Facility Name
IRCCS Casa Sollievo della Sofferenza Hospital
City
San Giovanni Rotondo
State/Province
FG
Country
Italy
Facility Name
Institute of Hematology and Medical Oncology "L. and A. Seràgnoli"
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
Hospital of Ravenna
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Facility Name
Fondazione Policlinico Tor Vergata, U.O.C. Ematologia
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Università Cattolica del Sacro Cuore (UNICATT)
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Ca' Foncello Hospital
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
VU University Medical Center
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
University Medical Centre Utrecht
City
Utrecht
ZIP/Postal Code
3584
Country
Netherlands
Facility Name
Hospital San Pedro De Alcantra
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Hospital MDACC
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Fundación Jiménez Diaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Virgen de la Victoria, Málaga
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
University Hospital of Hospital Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Radcliffe Hospitals and University of Oxford
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
Cardiff University School of Medicine
City
Cardiff
ZIP/Postal Code
CF14 4XN
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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