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A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)

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ClinicalTrials.gov Identifier: NCT00373529
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : March 24, 2011
Last Update Posted : April 14, 2014
Information provided by (Responsible Party):

September 7, 2006
September 8, 2006
February 24, 2011
March 24, 2011
April 14, 2014
October 2006
May 2008   (Final data collection date for primary outcome measure)
Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2) [ Time Frame: 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.
Overall Remission Rate
Complete list of historical versions of study NCT00373529 on ClinicalTrials.gov Archive Site
  • Kaplan Meier Estimate for Duration of Remission (DOR) [ Time Frame: Up to 2 years ]
    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 ]
    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 ]
    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 ]

    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 ]
    Percentage of participants who died within 30 days of the first dose of study drug, regardless of cause.
  • Duration of Remission
  • Disease-free Survival
  • Overall survival
  • Safety and Tolerability
  • 30-day Mortality Rate
Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors [ Time Frame: approximately Month 2 ]
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.
Not Provided
A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)
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

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.

Not Provided
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Acute Myelogenous Leukemia
  • Acute Myeloid Leukemia
Drug: clofarabine

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
Experimental: Clofarabine
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.
Intervention: Drug: clofarabine
Kantarjian HM, Erba HP, Claxton D, Arellano M, Lyons RM, Kovascovics T, Gabrilove J, Craig M, Douer D, Maris M, Petersdorf S, Shami PJ, Yeager AM, Eckert S, Abichandani R, Faderl S. Phase II study of clofarabine monotherapy in previously untreated older adults with acute myeloid leukemia and unfavorable prognostic factors. J Clin Oncol. 2010 Feb 1;28(4):549-55. doi: 10.1200/JCO.2009.23.3130. Epub 2009 Dec 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2010
May 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of AML (de novo, secondary or with an antecedent hematologic disorder [AHD])
  • Age ≥ 60 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Presence of at least one adverse prognostic factor: Age ≥ 70 years; or AHD; or ECOG performance status of 2; or Intermediate or unfavorable (i.e., adverse) karyotype defined as any cytogenetic profile except the presence of any of the following:

    • t(8;21)(q22;q22)
    • inv(16)(p13;q22 or t(16;16)(p13;q22)
    • t(15;17)(q22;q12) and variants.
  • Adequate renal and hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and Serum creatinine ≤ 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation
  • Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 40% or left ventricular fractional shortening ≥ 22%

Exclusion Criteria:

  • Diagnosis of acute promyelocytic leukemia
  • Prior treatment with clofarabine
  • Prior treatment for AML or an antecedent hematologic disorder
  • Prior hematopoietic stem cell transplant (HSCT)
  • Prior radiation therapy to the pelvis
  • Investigational agent received within 30 days prior to the first dose of study drug
  • Ongoing uncontrolled systemic infection
  • Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in-situ carcinoma or cervical intraepithelial neoplasia regardless of 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 based on PSA value are eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
  • Clinical evidence of central nervous system (CNS) involvement
  • Severe concurrent medical condition or psychiatric disorder that would preclude study participation
  • Positive human immunodeficiency virus (HIV) test
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Medical Monitor Genzyme, a Sanofi Company
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP