A Phase III Randomized, Double-blind, Controlled Study Comparing Clofarabine and Cytarabine Versus Cytarabine Alone in Adult Patients 55 Years and Older With Acute Myelogenous Leukemia (AML) Who Have Relapsed or Are Refractory After Receiving up to Two Prior Induction Regimens
After screening and eligibility assessment, patients were randomized (in a 1:1 ratio) to
receive either clofarabine or matching placebo, in addition to cytarabine. Randomization
was stratified by remission status following the first induction regimen (CR1): no
remission [i.e., CR1 = refractory] or remission <6 months vs remission ≥6 months. During
randomization by interactive voice response system (IVRS), there were 10 participants
misclassified to the CR1 <6 months stratum and 12 participants misclassified to CR1 ≥6
months stratum. The error did not affect the participants' treatment, only the
stratification. Due to the misclassification, outcomes that used strata in their analysis
were analyzed twice: once with the 'randomized stratification' which includes the
misclassification and once with the 'calculated stratification' in which participants appear
in the 'correct' strata.
Two clinical study reports were written for this study.
1. Clinical study report dated 7 April 2011 includes the entire treatment period of all
participants plus much of the follow-up. At that time, 33 participants in the
Clofarabine+cytarabine group and 29 participants in the placebo+cytarabine group were
still being follow-up post treatment. Results were reported on clinicaltrials.gov in
August 2011. Outcomes that used strata reported the 'calculated strata' on
clinicaltrials.gov.
2. Clinical study report dated 9 July 2012 includes all patient treatment experience plus
all long-term follow-up (a minimum of 2 years from the end of treatment or until the
patient died). The study was completed at that time. Outcomes that used strata
reported the 'randomized strata' on clinicaltrials.gov. AE records on
clinicaltrials.gov reflect the final database.
Outcomes that changed between the two clinical study reports due to the additional long-term
follow-up data are reported twice on clinicaltrials.gov (once from each clinical study
report) and the appropriate report date is included in the outcome description. Outcomes
from the 9 July 2012 report represent more complete data.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall Survival - Overall and by Calculated Strata (CSR 7-April-11)
Overall survival (OS) for the Full Analysis Set (FAS) and for the 2 calculated strata. OS was defined as the number of months from date of randomization until date of death due to any cause.
Day 1 (randomization) up to approximately 4 years
No
Medical Monitor
Study Director
Genzyme
United States: Food and Drug Administration
CLO34100405
NCT00317642
August 2006
January 2012
Name | Location |
---|---|
Arizona Cancer Center | Tucson, Arizona 85724 |
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
UCLA School of Medicine | Los Angeles, California 900121973 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Rocky Mountain Cancer Center | Denver, Colorado 80218 |
Vanderbilt University Medical Center | Nashville, Tennessee 37232-2516 |
Evanston Northwestern Healthcare | Evanston, Illinois 60201 |
Harold Alfond Center for Cancer Care | Augusta, Maine 04330 |
Duke University Medical Center | Durham, North Carolina 27710 |
Northwestern University | Chicago, Illinois 60611 |
Scripps Cancer Center | La Jolla, California 92037 |
University of Colorado Health Science Center | Aurora, Colorado 80010-0510 |
Roswell Park Cancer Center | Buffalo, New York 14263 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Louisiana State University Health Science Center | New Orleans, Louisiana 70112 |
Josephine Ford Cancer Center | Detroit, Michigan 48202 |
Wake Forest University School of Medicine | Winston-Salem, North Carolina 27157-1023 |
Oregon Health Science University | Portland, Oregon 97239 |
Mt. Sinai School of Medicine | New York, New York 10029 |
The Cancer Center at Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Sarah Cannon Research Institute | Nashville, Tennessee 37203 |
University of Kentucky, Markey Cancer Center | Lexington, Kentucky 40536-0093 |
Cancer Care Centers of South Texas | San Antonio, Texas 78229 |
Stanford Comprehensive Cancer Center | Stanford, California 94305 |
New York Medical Center | New York, New York 10016 |
University of Texas Health Sciences Center | San Antonio, Texas |
University of Tennessee Medical Center | Knoxville, Tennessee 37920 |
Mayo Clinical Hospital | Scottsdale, Arizona |
University of Arkansas for Medical Sciences, Arkansas Cancer Research Center | Little Rock, Arkansas |
University of Southern California, Kenneth Norris Cancer Center | Los Angeles, California |
Cancer Center of Central Connecticut | Southington, Connecticut |
Mecklenburg Medical Group | Charlotte, North Carolina |
UT Southwestern Medical Center, Simmons Comprehensive Cancer Center | Dallas, Texas |
University of Utah - Huntsman Cancer Institute | Salt Lake City, Utah |
West Virginia University Hospitals, Mary Babb Randolph Cancer Center | Morgantown, West Virginia |