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Acute Myelogenous LeukemiaPhase 2NCT00373529

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

A Phase 2 study testing clofarabine in people with Acute Myelogenous Leukemia and Acute Myeloid Leukemia, run by Genzyme, a Sanofi Company at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
clofarabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
20 sitesUnited States
Study dates
Oct 2006to May 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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%

Who cannot join

  • 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
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  • 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

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan

  • Emory University School of Medicine

    Atlanta, Georgia

  • Medical College of Georgia

    Augusta, Georgia

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts

  • Rush University Medical Center

    Chicago, Illinois

  • Rocky Mountain Cancer Centers

    Denver, Colorado

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania

  • University of MD Anderson Cancer Center

    Houston, Texas

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California

  • West Virginia University - HSC

    Morgantown, West Virginia

  • Vanderbilt University Medical Center

    Nashville, Tennessee

  • Mount Sinai School of Medicine

    New York, New York

  • Mayo Clinical Hospital

    Phoenix, Arizona

  • Oregon Health and Science University

    Portland, Oregon

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah

  • Cancer Care Centers of South Texas

    San Antonio, Texas

  • Scripps Cancer Center

    San Diego, California

  • Seattle Cancer Care Alliance

    Seattle, Washington

  • Cancer Center of Central Connecticut

    Southington, Connecticut

  • Arizona Cancer Center

    Tucson, Arizona

Other trials in United States

About this study

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

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.

Being tested
clofarabine
Keywords
Acute myelogenous leukemia, Acute myeloid leukemia, newly Diagnosed AML, Clofarabine, CLASSIC II, CLO243
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • clofarabineDrug

    Also called clolar

    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.

Study groups in NCT00373529
Study groupRoleWhat they receive
ClofarabineExperimentalParticipants 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.
Receives: Drug: clofarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: approximately Month 2

Secondary outcomes (5)

  1. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

  3. 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.

    Measured: Up to 2 years

  4. 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

    Measured: Up to 2 years

  5. 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.

    Measured: up to Day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionMay 2008
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00373529
Sponsor's protocol ID
CLO24300606
Status last verified
Mar 2014
First submitted
7 Sep 2006
Last updated
14 Apr 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20026805

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing clofarabine in people with Acute Myelogenous Leukemia and Acute Myeloid Leukemia, run by Genzyme, a Sanofi Company at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2) (time frame: approximately Month 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00373529, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2014.

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