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

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ClinicalTrials.gov Identifier: NCT03616470
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

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
Acute Myeloid Leukemia Drug: Uproleselan Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 : October 15, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2023


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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 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 [ Time Frame: up to 60 days ]
    Incidence of severe oral mucositis experienced in patients after treatment.

  2. 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


Other Outcome Measures:
  1. Event-free survival [ Time Frame: 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 [ Time Frame: 2 years ]
    Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first.

  3. Adverse events [ Time Frame: up to 5 months ]
    Frequency, severity, and relatedness of adverse events.

  4. Pharmacokinetic exposure (amount of uproleselan in the blood) [ Time Frame: up to 6 days ]
    The amount of uproleselan in the blood over time.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616470


Contacts
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Contact: GlycoMimetics, Inc. 240-243-1201 clinicaltrials@glycomimetics.com

Locations
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United States, California
UC San Diego Moore Cancer Center Recruiting
La Jolla, California, United States, 92093
Contact: Jesika Reiner, MPH    858-822-5364    Jreiner@ucsd.edu   
Principal Investigator: Matthew Wieduwilt, MD, PhD         
UC Davis Comprehensive Cancer Center Recruiting
Sacramento, California, United States, 95817
Contact: Steffany Lim    916-734-0561    sllim@ucdavis.edu   
Principal Investigator: Brian Jonas, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Daniel J DeAngelo, MD, PhD    617-632-2645    Daniel_Deangelo@dfci.harvard.edu   
Principal Investigator: Daniel DeAngelo, MD, PhD         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Ayan Gasanli    314-747-2449    agasanli@wustl.edu   
Contact: Megan Haney    314-454-8708    haneym@wustl.edu   
Principal Investigator: Geoffrey Uy, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Amanda Przespolewski, DO    716-845-7110    Amanda.Przespolewski@RoswellPark.org   
Contact: Wendy Walinski       Wendy.Walinski@RoswellPark.org   
Principal Investigator: Eunice Wang, MD         
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
Contact: Brandon DeLorme    585-275-5295    Brandon_Delorme@URMC.Rochester.edu   
Principal Investigator: Jane Liesveld, MD         
United States, North Carolina
Duke University Health System (DUHS) Recruiting
Durham, North Carolina, United States, 27710
Contact: Rachel Stowe, BSN, RN    919-681-4769    rachel.stowe@duke.edu   
Principal Investigator: Harry Erba, MD, PhD         
United States, Ohio
University Hospital Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Brenda Cooper, MD    216-884-3951    brenda.cooper@uhhospitals.org   
Principal Investigator: Brenda Cooper, MD         
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Anjali Advani, MD    216-445-9354    ADVANIA@ccf.org   
Principal Investigator: Anjali Advani, MD         
The Ohio State University Wexner Medical Center and James Cancer Hospital Recruiting
Columbus, Ohio, United States, 43210
Contact: Jennifer Dienno    614-293-0752    Jennifer.Dienno@osumc.edu   
Principal Investigator: Bhavana Bhatnagar, DO         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Naval Daver, MD    713-794-4392    NDaver@mdanderson.org   
Principal Investigator: Naval Daver, MD         
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Niall Curley    206-606-1231    Ncurley8@seattlecca.org   
Principal Investigator: Pamela Becker, MD, PhD         
Australia, New South Wales
Calvary Mater Newcastle Recruiting
Waratah, New South Wales, Australia, 2298
Contact: Michele Gambrill    +61 2 40144891    Michele.Gambrill@calvarymater.org.au   
Principal Investigator: Anoop Enjeti, MD         
Australia, Perth
Sir Charles Gairdner Hospital Recruiting
Nedlands, Perth, Australia, 6009
Contact: Louise Hay    +61 (0)8 6383 3207    louise.hay@health.wa.gov.au   
Contact: Aparna Chauhan         
Principal Investigator: Gavin Cull, MBBS, FRACP, DM         
Australia, Queensland
Townsville Hospital Recruiting
Douglas, Queensland, Australia, 4814
Contact: Kelvin Robertson    07 4433 1628    KELVIN.ROBERTSON@health.qld.gov.au   
Principal Investigator: Hock-Choong Lai, MBBS, FRACP, FRCPA         
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia, 4102
Contact: Jason Kelly       jason.kelly2@health.qld.gov.au   
Principal Investigator: Paula Marlton, MBBS, FRACP         
Australia, Victoria
Cancer Clinical Trials Centre (CCTC) Recruiting
Heidelberg, Victoria, Australia, 3084
Contact: Joanne Hawking    +61 3 9496 9720    Joanne.HAWKING@austin.org.au   
Principal Investigator: Chun Y Fong, MD         
Ireland
Galway University Hospital Recruiting
Galway, Ireland, H91 TK33
Contact: Jessica Walsh    091893314    Jessica.Walsh@nuigalway.ie   
Principal Investigator: Michael O'Dwyer, MD, FRCPI, FRCPath         
Netherlands
Amsterdam UMC (former VUMC) Recruiting
Amsterdam, Netherlands, 1081 HZ
Contact: Lillian van der Laan    +31204443534    l.laan@amsterdamumc.nl   
Contact       onderzoeksmedicatie@amsterdamumc.nl   
Principal Investigator: Jeroen J.W.M. Janssen, MD, PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9713 GZ
Contact: Hendrikus Boersma    +31503614331    h.h.boersma@umcg.nl   
Contact       trials@apoth.umcg.nl   
Principal Investigator: Emanuele Ammatuna, MD, PhD         
Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
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Principal Investigator: Daniel J DeAngelo, MD, PhD Dana-Farber Cancer Institute

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Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT03616470     History of Changes
Other Study ID Numbers: GMI-1271-301
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlycoMimetics Incorporated:
acute myeloid leukemia
AML
Relapsed AML
Refractory AML

Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms