Status:
COMPLETED
A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I)
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Acute Myelogenous Leukemia
Eligibility:
All Genders
55+ years
Phase:
PHASE3
Brief Summary
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) w...
Detailed Description
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 remi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
326 Patients enrolled
Trial Details
Trial ID
NCT00317642
Start Date
August 1 2006
End Date
January 1 2012
Last Update
April 14 2014
Active Locations (57)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinical Hospital
Scottsdale, Arizona, United States
2
Arizona Cancer Center
Tucson, Arizona, United States
3
University of Arkansas for Medical Sciences, Arkansas Cancer Research Center
Little Rock, Arkansas, United States
4
Scripps Cancer Center
La Jolla, California, United States