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

Completed · Phase 3 · Has a placebo group

Conditions studied: Acute Myelogenous Leukemia

In brief

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.

Key facts

Study ID: NCT00317642
Run by: Genzyme, a Sanofi Company
People needed: 326
Starts: 2006-08-01
Expected to finish: 2012-01-01
Last updated by the study team: 2014-04-14

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have a diagnosis of Acute Myelogenous Leukemia (AML) according to World Health Organization (WHO) classification
Relapsed after receiving up to 2 prior induction regimens (i.e. first or second relapse)or are refractory to not more than one prior combination chemotherapy induction regimen
Be ≥ 55 years of age
Have an Eastern Cooperative Oncology Group (ECOG) score of 0-2
Be able to comply with study procedures and follow-up examinations
Be nonfertile or agree to use birth control during the study through the end of treatment visit and for at least 90 days after the last dose of study drug
Have adequate liver and renal function as indicated by certain laboratory values

You may not qualify if…

Received previous treatment with clofarabine
Received bolus, intermediate or high-dose cytarabine as induction therapy unless certain remission criteria are met
Have received a hematopoietic stem cell transplant (HSCT) within the previous 3 months
Have moderate or severe graft versus host disease (GVHD), whether acute or chronic
Are receiving any other chemotherapy or investigational therapy. Patients must have been off prior AML therapy for at least 2-6 weeks prior to entering study.
Have a psychiatric disorder that would interfere with consent, study participation, or follow-up
Have an active, uncontrolled infection
Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system
Have been diagnosed with another malignancy, unless disease-free for at least 5 years; patients with treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia, regardless of the disease-free duration, are eligible for this study if definitive treatment for the condition has been completed; patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease are eligible if hormonal therapy has been initiated or the malignancy has been surgically removed.
Have clinical evidence suggestive of central nervous system (CNS) involvement with leukemia unless lumbar puncture confirms absence of leukemic blasts in the cerebrospinal fluid(CSF)
Known HIV positivity
Are pregnant or lactating

Where it is running

Arizona Cancer Center — Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Arkansas Cancer Research Center — Little Rock, Arkansas, United States
Scripps Cancer Center — La Jolla, California, United States
UCLA School of Medicine — Los Angeles, California, United States
University of Southern California, Kenneth Norris Cancer Center — Los Angeles, California, United States
Stanford Comprehensive Cancer Center — Stanford, California, United States
University of Colorado Health Science Center — Aurora, Colorado, United States
Rocky Mountain Cancer Center — Denver, Colorado, United States
Cancer Center of Central Connecticut — Southington, Connecticut, United States
Northwestern University — Chicago, Illinois, United States
Rush University Medical Center — Chicago, Illinois, United States
Evanston Northwestern Healthcare — Evanston, Illinois, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
University of Kentucky, Markey Cancer Center — Lexington, Kentucky, United States
Louisiana State University Health Science Center — Shreveport, Louisiana, United States
Harold Alfond Center for Cancer Care — Augusta, Maine, United States
Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
Josephine Ford Cancer Center — Detroit, Michigan, United States
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
The Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
Roswell Park Cancer Center — Buffalo, New York, United States
Mt. Sinai School of Medicine — New York, New York, United States
New York Medical Center — Valhalla, New York, United States
Mecklenburg Medical Group — Charlotte, North Carolina, United States
Mayo Clinical Hospital — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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