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

NCT03616470 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: GMI-1271-301
• Study Type: interventional
• Target: 388
• Locations: 9 countries
• Sites: 70

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

Conditions

Acute Myeloid Leukemia

Keywords

acute myeloid leukemia; AML; Relapsed AML; Refractory AML

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  5 years

Secondary Outcomes (2)

• Rate of severe oral mucositis

  up to 60 days

• Overall response rate

  Up to 60 days

Other Outcomes (8)

• Event-free survival

  5 years

• Duration of remission

  5 years

• Adverse events

  up to 5 months

Study Arms (2)

Uproleselan (GMI-1271)

EXPERIMENTAL

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

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)

Drug: Placebo

Interventions

Uproleselan DRUG

A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin

Uproleselan (GMI-1271)

Placebo DRUG

Saline, 0.9% Sodium Chloride

Placebo (Saline, 0.9% Sodium Chloride)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlycoMimetics Incorporated: lead

Study Sites (70)

UC San Diego Moore Cancer Center

La Jolla, California, 92093, United States

Location

University of California, Los Angeles - UCLA

Los Angeles, California, 90095, United States

Location

University of California Irvine

Orange, California, 92868, United States

Location

Stanford Cancer Institute

Palo Alto, California, 94304, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Northside Hospital - Medical Tower

Atlanta, Georgia, 30342, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Hudson Valley Cancer Center

Hawthorne, New York, 10532, United States

Location

Columbia University Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Duke University Health System (DUHS)

Durham, North Carolina, 27710, United States

Location

Wake Forest Baptist Hospital

Winston-Salem, North Carolina, 27157, United States

Location

University Hospital Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center and James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Vanderbilt-Ingram Cancer Center Clinical Trials Office

Nashville, Tennessee, 37203, United States

Location

Charles A. Sammons Cancer Center at Dallas

Dallas, Texas, 75246, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Perth, 6009, Australia

Location

Townsville Hospital

Douglas, Queensland, 4814, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Queensland, 4102, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

Cancer Clinical Trials Centre (CCTC)

Heidelberg, Victoria, 3084, Australia

Location

Tom Baker Cancer Center

Calgary, Alberta, T2N 4N2, Canada

Location

University of Alberta Princess Margaret Hospital

Edmonton, Alberta, Canada

Location

The Leukemia/BMT Program of BC Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E0V9, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

University Health Network (UHN) - Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2MG, Canada

Location

Centre Hospitalier Universitaire d'Angers

Angers, 49933, France

Location

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33604, France

Location

Centre Hospitalier Universitaire Grenoble Alpes

La Tronche, 38700, France

Location

Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO)

Marseille, 13273, France

Location

Saint-Louis Hospital

Paris, 75010, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 75010, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86021, France

Location

Galway University Hospital

Galway, H91 TK33, Ireland

Location

IRCCS Casa Sollievo della Sofferenza Hospital

San Giovanni Rotondo, FG, Italy

Location

Institute of Hematology and Medical Oncology "L. and A. Seràgnoli"

Bologna, 40138, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, 47014, Italy

Location

Hospital of Ravenna

Ravenna, 48121, Italy

Location

Fondazione Policlinico Tor Vergata, U.O.C. Ematologia

Roma, 00133, Italy

Location

Università Cattolica del Sacro Cuore (UNICATT)

Rome, 00168, Italy

Location

Ca' Foncello Hospital

Treviso, 31100, Italy

Location

VU University Medical Center

Amsterdam, 1081 HV, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

University Medical Centre Utrecht

Utrecht, 3584, Netherlands

Location

Hospital San Pedro De Alcantra

Cáceres, 10003, Spain

Location

Hospital MDACC

Madrid, 28033, Spain

Location

Hospital Universitario Fundación Jiménez Diaz

Madrid, 28040, Spain

Location

Hospital Virgen de la Victoria, Málaga

Málaga, 29010, Spain

Location

Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital Universitario de Salamanca

Salamanca, 37007, Spain

Location

University Hospital of Hospital Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46026, Spain

Location

Radcliffe Hospitals and University of Oxford

Oxford, England, OX3 7LJ, United Kingdom

Location

Cardiff University School of Medicine

Cardiff, CF14 4XN, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

uproleselan

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Daniel J DeAngelo, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 6, 2018
• Study Start: October 15, 2018
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

US (30); IE (1); AU (6); FR (7); GB (2); ES (8); CA (6); NL (3); IT (7)