Status:
COMPLETED
A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Acute Myelogenous Leukemia
Acute Myeloid Leukemia
Eligibility:
All Genders
60+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00373529
Start Date
October 1 2006
End Date
May 1 2010
Last Update
April 14 2014
Active Locations (20)
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1
Mayo Clinical Hospital
Phoenix, Arizona, United States
2
Arizona Cancer Center
Tucson, Arizona, United States
3
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States
4
Scripps Cancer Center
San Diego, California, United States