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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


Phase 2
60 Years
N/A
Not Enrolling
Both
Acute Myelogenous Leukemia, Acute Myeloid Leukemia

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)

Outcome Description:

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.

Outcome Time Frame:

approximately Month 2

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

CLO24300606

NCT ID:

NCT00373529

Start Date:

October 2006

Completion Date:

May 2010

Related Keywords:

  • Acute Myelogenous Leukemia
  • Acute Myeloid Leukemia
  • Acute myelogenous leukemia
  • Acute myeloid leukemia
  • newly Diagnosed AML
  • Clofarabine
  • CLASSIC II
  • CLO243
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mount Sinai School of MedicineNew York, New York  10029
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Rush University Medical CenterChicago, Illinois  60612-3824
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Emory University School of MedicineAtlanta, Georgia  30322
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Seattle Cancer Care AllianceSeattle, Washington  98109
Rocky Mountain Cancer CentersThornton, Colorado  80260
Medical College of GeorgiaAugusta, Georgia  30912
Scripps Cancer CenterLa Jolla, California  92037
Oregon Health and Science UniversityPortland, Oregon  97201
Penn State Hershey Medical CenterHershey, Pennsylvania  17033
Cancer Care Centers of South TexasSan Antonio, Texas  78229
Mayo Clinical HospitalScottsdale, Arizona  
Cancer Center of Central ConnecticutSouthington, Connecticut  
University of Utah - Huntsman Cancer InstituteSalt Lake City, Utah  
University of MD Anderson Cancer CenterHouston, Texas  
West Virginia University - HSCMorgantown, West Virginia