Clinical trial NCT00373529: A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia
Acute Myeloid Leukemia
Keywords: Acute myelogenous leukemia
Acute myeloid leukemia
newly Diagnosed AML
Clofarabine
CLASSIC II
CLO243
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-09-08
Enrollment: 116
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)
timeFrame: approximately Month 2
Secondary outcomes:
measure: Kaplan Meier Estimate for Duration of Remission (DOR)
timeFrame: Up to 2 years
measure: Kaplan Meier Estimate for Disease-free Survival (DFS)
timeFrame: Up to 2 years
measure: Kaplan Meier Estimates for Overall Survival (OS)
timeFrame: Up to 2 years
measure: Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods
timeFrame: Up to 2 years
measure: Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)
timeFrame: up to Day 30
Other outcomes:
measure: Number of Participants Achieving Overall Remission After A Maximum of Two Cycles by Subgroup of Baseline Prognostic Factors
timeFrame: approximately Month 2
Locations:
city: Phoenix
country: United States
facility: Mayo Clinical Hospital
state: Arizona
city: Tucson
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center and Hospital
state: California
city: San Diego
country: United States
facility: Scripps Cancer Center
state: California
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Southington
country: United States
facility: Cancer Center of Central Connecticut
state: Connecticut
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: University of MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: Cancer Care Centers of South Texas
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - Huntsman Cancer Institute
state: Utah
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
city: Morgantown
country: United States
facility: West Virginia University - HSC
state: West Virginia
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: 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.