A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)
Public ClinicalTrials.gov record NCT00317642. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute or refractory lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. There is no recommended standard treatment for relapsed or refractory acute myelogenous leukemia in older patients. Cytarabine is the most commonly used drug to treat these patients. This study will determine if there is benefit by combining clofarabine with cytarabine. Patients will be randomized to receive up to 3 cycles of treatment with either placebo in combination with cytarabine or clofarabine in combination with cytarabine. Randomization was stratified by remission status following the first induction regimen (no remission \[i.e., CR1 = refractory\] or remission \<6 months vs CR1 = remission ≥6 months). CR1 is defined as remission after first pre-study induction regimen. The safety and tolerability of clofarabine in combination with cytarabine and cytarabine alone will be monitored throughout the study.
Study identification
- NCT ID
- NCT00317642
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 326 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 55 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2006
- Primary completion
- Dec 31, 2011
- Completion
- Dec 31, 2011
- Last update posted
- Apr 13, 2014
2006 – 2012
United States locations
- U.S. sites
- 41
- U.S. states
- 25
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinical Hospital | Scottsdale | Arizona | — | — |
| Arizona Cancer Center | Tucson | Arizona | — | — |
| University of Arkansas for Medical Sciences, Arkansas Cancer Research Center | Little Rock | Arkansas | — | — |
| Scripps Cancer Center | La Jolla | California | — | — |
| UCLA School of Medicine | Los Angeles | California | — | — |
| University of Southern California, Kenneth Norris Cancer Center | Los Angeles | California | — | — |
| Stanford Comprehensive Cancer Center | Stanford | California | — | — |
| University of Colorado Health Science Center | Aurora | Colorado | — | — |
| Rocky Mountain Cancer Center | Denver | Colorado | — | — |
| Cancer Center of Central Connecticut | Southington | Connecticut | — | — |
| Northwestern University | Chicago | Illinois | — | — |
| Rush University Medical Center | Chicago | Illinois | — | — |
| Evanston Northwestern Healthcare | Evanston | Illinois | — | — |
| University of Kansas Medical Center | Kansas City | Kansas | — | — |
| University of Kentucky, Markey Cancer Center | Lexington | Kentucky | — | — |
| Louisiana State University Health Science Center | Shreveport | Louisiana | — | — |
| Harold Alfond Center for Cancer Care | Augusta | Maine | — | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | — | — |
| Josephine Ford Cancer Center | Detroit | Michigan | — | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | — | — |
| The Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | — | — |
| Roswell Park Cancer Center | Buffalo | New York | — | — |
| Mt. Sinai School of Medicine | New York | New York | — | — |
| New York Medical Center | Valhalla | New York | — | — |
| Mecklenburg Medical Group | Charlotte | North Carolina | — | — |
| Duke University Medical Center | Durham | North Carolina | — | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | — | — |
| Gabrail Cancer Center | Canton | Ohio | — | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | — | — |
| Oregon Health Science University | Portland | Oregon | — | — |
| Medical University of South Carolina | Charleston | South Carolina | — | — |
| University of Tennessee Medical Center | Knoxville | Tennessee | — | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | — | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | — | — |
| UT Southwestern Medical Center, Simmons Comprehensive Cancer Center | Dallas | Texas | — | — |
| MD Anderson Cancer Center | Houston | Texas | — | — |
| Cancer Care Centers of South Texas | San Antonio | Texas | — | — |
| University of Texas Health Sciences Center | San Antonio | Texas | — | — |
| University of Utah - Huntsman Cancer Institute | Salt Lake City | Utah | — | — |
| West Virginia University Hospitals, Mary Babb Randolph Cancer Center | Morgantown | West Virginia | — | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | — | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00317642, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 13, 2014 · Synced Sep 12, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00317642 live on ClinicalTrials.gov.