A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)

PHASE3CompletedINTERVENTIONAL
Enrollment

326

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

January 31, 2012

Study Completion Date

January 31, 2012

Conditions
Acute Myelogenous Leukemia
Interventions
DRUG

clofarabine (IV formulation)

clofarabine (IV formulation) infusion 40mg/m\^2 / day up to 3 cycles

DRUG

placebo

placebo (sodium Chloride) 1-hour IV infusion

DRUG

cytarabine

cytarabine IV infusion 1g/m\^2/day for up to 3 cycles

Trial Locations (57)

89081

Universitatsklinikum Ulm, Ulm

Unknown

Mayo Clinical Hospital, Scottsdale

Arizona Cancer Center, Tucson

University of Arkansas for Medical Sciences, Arkansas Cancer Research Center, Little Rock

Scripps Cancer Center, La Jolla

UCLA School of Medicine, Los Angeles

University of Southern California, Kenneth Norris Cancer Center, Los Angeles

Stanford Comprehensive Cancer Center, Stanford

University of Colorado Health Science Center, Aurora

Rocky Mountain Cancer Center, Denver

Cancer Center of Central Connecticut, Southington

Northwestern University, Chicago

Rush University Medical Center, Chicago

Evanston Northwestern Healthcare, Evanston

University of Kansas Medical Center, Kansas City

University of Kentucky, Markey Cancer Center, Lexington

Louisiana State University Health Science Center, Shreveport

Harold Alfond Center for Cancer Care, Augusta

Beth Israel Deaconess Medical Center, Boston

Josephine Ford Cancer Center, Detroit

Dartmouth Hitchcock Medical Center, Lebanon

The Cancer Center at Hackensack University Medical Center, Hackensack

Roswell Park Cancer Center, Buffalo

Mt. Sinai School of Medicine, New York

New York Medical Center, Valhalla

Mecklenburg Medical Group, Charlotte

Duke University Medical Center, Durham

Wake Forest University School of Medicine, Winston-Salem

Gabrail Cancer Center, Canton

University of Oklahoma Health Sciences Center, Oklahoma City

Oregon Health Science University, Portland

Medical University of South Carolina, Charleston

University of Tennessee Medical Center, Knoxville

Sarah Cannon Research Institute, Nashville

Vanderbilt University Medical Center, Nashville

UT Southwestern Medical Center, Simmons Comprehensive Cancer Center, Dallas

MD Anderson Cancer Center, Houston

Cancer Care Centers of South Texas, San Antonio

University of Texas Health Sciences Center, San Antonio

University of Utah - Huntsman Cancer Institute, Salt Lake City

West Virginia University Hospitals, Mary Babb Randolph Cancer Center, Morgantown

Medical College of Wisconsin, Milwaukee

Saint John Regional Hospital, Saint John

Juravinski Cancer Center, Hamilton

Hopital Maisonneuve-Rosemont, Montreal

Service Maladies du Sang, CHU Angers, Angers

Hopital Claude Huriez CHRU de Lille, Lille

Hopital Edouard Herriot, Lyon

Institut Paoli Calmettes, Marseille

Hopital Hotel Dieu, Nantes

Hopital Purpan, Toulouse

Medizinische Hochschule Hannover, Zentrum fur Innere Medizin, Abt. Haematologie / Onkologie, Hanover

Medizinische Klinik der Technischen, Universität München, Munich

Ospedali Riuniti Bergamo, Bergamo

A.O Ospedale Niguarda Ca'Granda, Milan

N.O. San Gerardo, Monza

"Azienda Ospedaliera Antonio Cardarelli", Napoli

All Listed Sponsors
lead

Genzyme, a Sanofi Company

INDUSTRY

NCT00317642 - A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I) | Biotech Hunter | Biotech Hunter