Clinical trial NCT03616470: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Keywords: acute myeloid leukemia
AML
Relapsed AML
Refractory AML
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
First posted: 2018-08-06
Enrollment: 388
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Overall survival
timeFrame: 5 years
Secondary outcomes:
measure: Rate of severe oral mucositis
timeFrame: up to 60 days
measure: Overall response rate
timeFrame: Up to 60 days
Other outcomes:
measure: Event-free survival
timeFrame: 5 years
measure: Duration of remission
timeFrame: 5 years
measure: Adverse events
timeFrame: up to 5 months
measure: Pharmacokinetic exposure (amount of uproleselan in the blood)
timeFrame: up to 6 days
measure: Event-free survival
timeFrame: 1 year
measure: Overall survival
timeFrame: 2 years
measure: Overall survival
timeFrame: 3 years
measure: Overall survival
timeFrame: 4 years
Locations:
city: La Jolla
country: United States
facility: UC San Diego Moore Cancer Center
state: California
city: Los Angeles
country: United States
facility: University of California, Los Angeles - UCLA
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Institute
state: California
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Atlanta
country: United States
facility: Emory Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital - Medical Tower
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Westwood
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Hawthorne
country: United States
facility: Hudson Valley Cancer Center
state: New York
city: New York
country: United States
facility: Columbia University Herbert Irving Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Health System (DUHS)
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Hospital
state: North Carolina
city: Cleveland
country: United States
facility: University Hospital Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center and James Cancer Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center Clinical Trials Office
state: Tennessee
city: Dallas
country: United States
facility: Charles A. Sammons Cancer Center at Dallas
state: Texas
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute, University of Utah
state: Utah
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Waratah
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Perth
city: Douglas
country: Australia
facility: Townsville Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Heidelberg
country: Australia
facility: Cancer Clinical Trials Centre (CCTC)
state: Victoria
city: Calgary
country: Canada
facility: Tom Baker Cancer Center
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Princess Margaret Hospital
state: Alberta
city: Vancouver
country: Canada
facility: The Leukemia/BMT Program of BC Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: CancerCare Manitoba
state: Manitoba
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network (UHN) - Princess Margaret Cancer Centre
state: Ontario
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes
city: Marseille
country: France
facility: Unité d'Evaluation Thérapeutique en Onco-Hématologie (ETHO)
city: Paris
country: France
facility: Saint-Louis Hospital
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Galway
country: Ireland
facility: Galway University Hospital
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza Hospital
state: FG
city: Bologna
country: Italy
facility: Institute of Hematology and Medical Oncology "L. and A. Seràgnoli"
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
city: Ravenna
country: Italy
facility: Hospital of Ravenna
city: Roma
country: Italy
facility: Fondazione Policlinico Tor Vergata, U.O.C. Ematologia
city: Rome
country: Italy
facility: Università Cattolica del Sacro Cuore (UNICATT)
city: Treviso
country: Italy
facility: Ca' Foncello Hospital
city: Amsterdam
country: Netherlands
facility: VU University Medical Center
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Utrecht
country: Netherlands
facility: University Medical Centre Utrecht
city: Cáceres
country: Spain
facility: Hospital San Pedro De Alcantra
city: Madrid
country: Spain
facility: Hospital MDACC
city: Madrid
country: Spain
facility: Hospital Universitario Fundación Jiménez Diaz
city: Málaga
country: Spain
facility: Hospital Virgen de la Victoria, Málaga
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
city: Santander
country: Spain
facility: University Hospital of Hospital Marqués de Valdecilla
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Oxford
country: United Kingdom
facility: Radcliffe Hospitals and University of Oxford
state: England
city: Cardiff
country: United Kingdom
facility: Cardiff University School of Medicine
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Daniel J DeAngelo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: