Clolar (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 lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens. This study will evaluate the efficacy of clofarabine in elderly patients with acute myelogenous leukemia (AML) who are unlikely to benefit from treatment with intensive chemotherapy regimens (cytarabine and anthracycline based regimens) used in younger patients with AML.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Induction cycle 1: cycle 1 of clofarabine 30 mg/m\^2/day as a 1-hour intravenous infusion for 5 consecutive days. Reinduction (cycle 2) and/or Consolidation cycles (cycles 2-6): cycles repeated minimally every 28 days, of clofarabine 20 mg/m\^2/day as a 1-hour intravenous infusion for 5 consecutive days.
Mayo Clinical Hospital
Phoenix, Arizona, United States
Arizona Cancer Center
Tucson, Arizona, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
Scripps Cancer Center
San Diego, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Cancer Center of Central Connecticut
Southington, Connecticut, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
...and 10 more locations
Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)
Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment. Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp). CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease. Partial remission(PR) includes recovery of peripheral blood cells with improved but still abnormal values in leukemic blast cells.
Time frame: approximately Month 2
Kaplan Meier Estimate for Duration of Remission (DOR)
DOR was defined as the number of days from achievement of OR as assessed by the Independent Response Review Panel (IRRP) until IRRP-determined disease recurrence or death (any cause), plus 1 day. Participants who initiated alternative antileukemic treatment while in remission were censored on the date the therapy was initiated or on the date of last follow-up.
Time frame: Up to 2 years
Kaplan Meier Estimate for Disease-free Survival (DFS)
DFS was defined as the number of days from achievement of IRRP-determined overall response until IRRP-determined disease recurrence or death (any cause), regardless of intervening alternative antileukemic treatment, plus 1 day.
Time frame: Up to 2 years
Kaplan Meier Estimates for Overall Survival (OS)
OS was defined as the number of days from first dose of clofarabine until death for all participants, plus 1 day.
Time frame: Up to 2 years
Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods
Participants with AEs that occurred during the treatment and follow-up periods. AEs were classified according to severity (graded using National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0) and relationship to study drug. Treatment emergent is defined as any event that either first presents after baseline or worsens in severity after baseline. NCI Common Terminology Criteria for Severity: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5= Death related to AE
Time frame: Up to 2 years
Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)
Percentage of participants who died within 30 days of the first dose of study drug, regardless of cause.
Time frame: up to Day 30
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