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ACTIVE NOT RECRUITING
NCT03701308
PHASE2/PHASE3

Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II/III trial studies how well daunorubicin and cytarabine with or without uproleselan works in treating older adult patients with acute myeloid leukemia receiving intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Uproleselan may prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with uproleselan may work better in treating patients with acute myeloid leukemia compared to daunorubicin and cytarabine alone.

Official title: A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

Key Details

Gender

All

Age Range

60 Years - Any

Study Type

INTERVENTIONAL

Enrollment

267

Start Date

2019-03-28

Completion Date

2026-10-26

Last Updated

2026-01-21

Healthy Volunteers

No

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood collection

PROCEDURE

Bone Marrow Aspiration

Undergo bone marrow aspirate

PROCEDURE

Bone Marrow Biopsy

Undergo bone marrow biopsy

DRUG

Cytarabine

Given IV

DRUG

Daunorubicin

Given IV

PROCEDURE

Echocardiography Test

Undergo ECHO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

DRUG

Uproleselan

Given IV

Locations (188)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Community Cancer Institute

Clovis, California, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Luke's Cancer Institute - Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Walter Knox Memorial Hospital

Emmett, Idaho, United States

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

SIH Cancer Institute

Carterville, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Valley Radiation Oncology

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Southwest Illinois Health Services LLP

Swansea, Illinois, United States

Indiana University/Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, United States

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic - Ames

Ames, Iowa, United States

McFarland Clinic - Boone

Boone, Iowa, United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

University of Iowa/Holden Comprehensive Cancer Center

Iowa City, Iowa, United States

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Siouxland Regional Cancer Center

Sioux City, Iowa, United States

University of Kansas Cancer Center

Kansas City, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Ascension Via Christi Hospitals Wichita

Wichita, Kansas, United States

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Wesley Medical Center

Wichita, Kansas, United States

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana, United States

Eastern Maine Medical Center

Bangor, Maine, United States

Lafayette Family Cancer Center-EMMC

Brewer, Maine, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Hickman Cancer Center

Adrian, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Beacon Kalamazoo Cancer Center

Kalamazoo, Michigan, United States

Toledo Clinic Cancer Centers-Monroe

Monroe, Michigan, United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Corewell Health Reed City Hospital

Reed City, Michigan, United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

University of Michigan Health - West

Wyoming, Michigan, United States

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Essentia Health Cancer Center

Duluth, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Health Partners Inc

Minneapolis, Minnesota, United States

Monticello Cancer Center

Monticello, Minnesota, United States

New Ulm Medical Center

New Ulm, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Coborn Cancer Center at Saint Cloud Hospital

Saint Cloud, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Parkland Health Center-Bonne Terre

Bonne Terre, Missouri, United States

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, United States

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, United States

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, United States

Parkland Health Center - Farmington

Farmington, Missouri, United States

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Siteman Cancer Center-South County

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Community Hospital of Anaconda

Anaconda, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Great Falls Clinic

Great Falls, Montana, United States

Saint Peter's Community Hospital

Helena, Montana, United States

Logan Health Medical Center

Kalispell, Montana, United States

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Community Medical Center

Missoula, Montana, United States

Nebraska Methodist Hospital

Omaha, Nebraska, United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States

Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Lebanon, New Hampshire, United States

Morristown Medical Center

Morristown, New Jersey, United States

Overlook Hospital

Summit, New Jersey, United States

Northwell Health/Center for Advanced Medicine

Lake Success, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Mount Sinai Hospital

New York, New York, United States

University of Rochester

Rochester, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Wake Forest Baptist Health - Wilkes Medical Center

Wilkesboro, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Sanford Roger Maris Cancer Center

Fargo, North Dakota, United States

Case Western Reserve University

Cleveland, Ohio, United States

MetroHealth Medical Center

Cleveland, Ohio, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Mercy Health - Perrysburg Hospital

Perrysburg, Ohio, United States

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Saint Alphonsus Cancer Care Center-Baker City

Baker City, Oregon, United States

Saint Alphonsus Cancer Care Center-Ontario

Ontario, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Saint Francis Hospital

Greenville, South Carolina, United States

Saint Francis Cancer Center

Greenville, South Carolina, United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina, United States

Sanford Cancer Center Oncology Clinic

Sioux Falls, South Dakota, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, United States

Marshfield Medical Center - Weston

Weston, Wisconsin, United States

Billings Clinic-Cody

Cody, Wyoming, United States

Welch Cancer Center

Sheridan, Wyoming, United States