Skip to main content
OpenTrials
Completed

NCT Number: NCT00373529

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Myelogenous Leukemia Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinical Hospital, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clofarabine

Drug

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 names: clolar

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2010
First posted
Sep 8, 2006
Registry last updated
Apr 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.