A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)
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.
Acute Myelogenous Leukemia
Acute Myeloid Leukemia
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Single Agent Clofarabine in Previously Untreated Older Adult Patients With Acute Myelogenous Leukemia (AML) for Whom Standard Induction Chemotherapy is Unlikely to be of Benefit|
- Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2) [ Time Frame: approximately Month 2 ] [ Designated as safety issue: No ]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.
- Kaplan Meier Estimate for Duration of Remission (DOR) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]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.
- Kaplan Meier Estimate for Disease-free Survival (DFS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]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.
- Kaplan Meier Estimates for Overall Survival (OS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]OS was defined as the number of days from first dose of clofarabine until death for all participants, plus 1 day.
- Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
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
- Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate) [ Time Frame: up to Day 30 ] [ Designated as safety issue: Yes ]Percentage of participants who died within 30 days of the first dose of study drug, regardless of cause.
- Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors [ Time Frame: approximately Month 2 ] [ Designated as safety issue: No ]The number of participants within each subgroup of baseline prognostic factors of the full analysis set who achieved a best response of either a complete response (CR) or a complete response in the absence of platelet recovery (CRp) as determined by the Independent Response Review Panel following a maximum of two cycles of treatment.
|Study Start Date:||October 2006|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
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.
Other Name: clolar
Please refer to this study by its ClinicalTrials.gov identifier: NCT00373529
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|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|