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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
Not Enrolling
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

- 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

- Positive human immunodeficiency virus (HIV) test

Type of Study:


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:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




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
  • CLO243
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



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