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

GlycoMimetics Incorporated (Industry)
Overall Status
Active, not recruiting ID

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Actual Enrollment :
388 participants
Intervention Model:
Parallel Assignment
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
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
Actual Study Start Date :
Oct 15, 2018
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Overall survival [5 years]

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

Secondary Outcome Measures

  1. Rate of severe oral mucositis [up to 60 days]

    Incidence of severe oral mucositis experienced in patients after treatment.

  2. Overall response rate [Up to 60 days]

    Proportion of subjects who achieve a complete remission [CR] or CR with partial recovery [CRh] of blood counts

Other Outcome Measures

  1. Event-free survival [2 years]

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

  2. Duration of remission [2 years]

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

  3. Adverse events [up to 5 months]

    Frequency, severity, and relatedness of adverse events.

  4. Pharmacokinetic exposure (amount of uproleselan in the blood) [up to 6 days]

    The amount of uproleselan in the blood over time.

Eligibility Criteria


Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Accepts 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.

Contacts and Locations


Site City State Country Postal Code
1 UC San Diego Moore Cancer Center La Jolla California United States 92093
2 University of California, Los Angeles - UCLA Los Angeles California United States 90095
3 University of California Irvine Orange California United States 92868
4 Stanford Cancer Institute Palo Alto California United States 94304
5 UC Davis Comprehensive Cancer Center Sacramento California United States 95817
6 Emory Winship Cancer Institute Atlanta Georgia United States 30322
7 Northside Hospital - Medical Tower Atlanta Georgia United States 30342
8 Rush University Medical Center Chicago Illinois United States 60612
9 The University of Kansas Cancer Center Westwood Kansas United States 66205
10 Dana Farber Cancer Institute Boston Massachusetts United States 02215
11 University of Michigan Ann Arbor Michigan United States 48109
12 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201
13 Washington University School of Medicine Saint Louis Missouri United States 63110
14 Roswell Park Cancer Institute Buffalo New York United States 14263
15 Hudson Valley Cancer Center Hawthorne New York United States 10532
16 Columbia University Herbert Irving Comprehensive Cancer Center New York New York United States 10032
17 Memorial Sloan Kettering Cancer Center New York New York United States 10065
18 Weill Cornell Medical College New York New York United States 10065
19 University of Rochester Medical Center Rochester New York United States 14642
20 Duke University Health System (DUHS) Durham North Carolina United States 27710
21 Wake Forest Baptist Hospital Winston-Salem North Carolina United States 27157
22 University Hospital Cleveland Medical Center Cleveland Ohio United States 44106
23 Cleveland Clinic Cleveland Ohio United States 44195
24 The Ohio State University Wexner Medical Center and James Cancer Hospital Columbus Ohio United States 43210
25 Stephenson Cancer Center Oklahoma City Oklahoma United States 73104
26 Vanderbilt-Ingram Cancer Center Clinical Trials Office Nashville Tennessee United States 37203
27 Charles A. Sammons Cancer Center at Dallas Dallas Texas United States 75246
28 The University of Texas MD Anderson Cancer Center Houston Texas United States 77030
29 Huntsman Cancer Institute, University of Utah Salt Lake City Utah United States 84112
30 Seattle Cancer Care Alliance Seattle Washington United States 98109
31 Calvary Mater Newcastle Waratah New South Wales Australia 2298
32 Sir Charles Gairdner Hospital Nedlands Perth Australia 6009
33 Townsville Hospital Douglas Queensland Australia 4814
34 Princess Alexandra Hospital Woolloongabba Queensland Australia 4102
35 Flinders Medical Centre Bedford Park South Australia Australia 5042
36 Cancer Clinical Trials Centre (CCTC) Heidelberg Victoria Australia 3084
37 Tom Baker Cancer Center Calgary Alberta Canada T2N 4N2
38 University of Alberta Princess Margaret Hospital Edmonton Alberta Canada
39 The Leukemia/BMT Program of BC Vancouver General Hospital Vancouver British Columbia Canada
40 CancerCare Manitoba Winnipeg Manitoba Canada R3E0V9
41 Juravinski Cancer Centre Hamilton Ontario Canada L8V 5C2
42 University Health Network (UHN) - Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2MG
43 Centre Hospitalier Universitaire d'Angers Angers France 49933
44 Centre Hospitalier Universitaire de Bordeaux Bordeaux France 33604
45 Centre Hospitalier Universitaire Grenoble Alpes La Tronche France 38700
46 Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO) Marseille France 13273
47 Saint-Louis Hospital Paris France 75010
48 Centre Hospitalier Lyon Sud Pierre-Bénite France 75010
49 Centre Hospitalier Universitaire de Poitiers Poitiers France 86021
50 Galway University Hospital Galway Ireland H91 TK33
51 IRCCS Casa Sollievo della Sofferenza Hospital San Giovanni Rotondo FG Italy
52 Institute of Hematology and Medical Oncology "L. and A. Seràgnoli" Bologna Italy 40138
53 Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) Meldola Italy 47014
54 Hospital of Ravenna Ravenna Italy 48121
55 Fondazione Policlinico Tor Vergata, U.O.C. Ematologia Roma Italy 00133
56 Università Cattolica del Sacro Cuore (UNICATT) Rome Italy 00168
57 Ca' Foncello Hospital Treviso Italy 31100
58 Amsterdam UMC (former VUMC) Amsterdam Netherlands 1081 HZ
59 University Medical Center Groningen Groningen Netherlands 9713 GZ
60 University Medical Centre Utrecht Utrecht Netherlands 3584
61 Hospital San Pedro De Alcantra Cáceres Spain 10003
62 Hospital MDACC Madrid Spain 28033
63 Hospital Universitario Fundación Jiménez Diaz Madrid Spain 28040
64 Hospital Virgen de la Victoria, Málaga Málaga Spain 29010
65 Clínica Universidad de Navarra Pamplona Spain 31008
66 Hospital Universitario de Salamanca Salamanca Spain 37007
67 University Hospital of Hospital Marqués de Valdecilla Santander Spain 39008
68 Hospital Universitari i Politècnic La Fe Valencia Spain 46026
69 Radcliffe Hospitals and University of Oxford Oxford England United Kingdom OX3 7LJ
70 Cardiff University School of Medicine Cardiff United Kingdom CF14 4XN

Sponsors and Collaborators

  • GlycoMimetics Incorporated


  • Principal Investigator: Daniel J DeAngelo, MD, PhD, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
GlycoMimetics Incorporated Identifier:
Other Study ID Numbers:
  • GMI-1271-301
First Posted:
Aug 6, 2018
Last Update Posted:
Apr 6, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by GlycoMimetics Incorporated
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 6, 2022