A Study of Clofarabine and Cytarabine for Older Patients With Relapsed or Refractory Acute Myelogenous Leukemia (AML)(CLASSIC I) - NCT00317642- (Clinical Trial 141158)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy141158.aspx
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Milwaukee |
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State:
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WI |
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| Conditions: |
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Acute Myelogenous Leukemia |
| Purpose: |
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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.
There is no recommended standard treatment for relapsed or refractory acute myelogenous
leukemia in patients older than 59 years. Cytarabine is the most commonly used drug to treat
these patients. This study will determine if there is additional benefit by combining
clofarabine with cytarabine.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Provide signed, written informed consent
- Have a diagnosis of AML according to World Health Organization (WHO) classification
- Relapsed after receiving up to 2 prior induction regimens (i.e. first or second
relapse)or are refractory to not more than one prior combination chemotherapy
induction regimen
- Be ≥ 55 years of age
- Have an ECOG score of 0-2
- Be able to comply with study procedures and follow-up examinations
- Be nonfertile or agree to use birth control during the study through the end of
treatment visit and for at least 90 days after the last dose of study drug
- Have adequate liver and renal function as indicated by certain laboratory values
Exclusion Criteria:
- Received previous treatment with clofarabine
- Received bolus, intermediate or high-dose cytarabine as induction therapy unless
certain remission criteria are met
- Have received a hematopoietic stem cell transplant (HSCT) within the previous 3
months
- Have moderate or severe graft versus host disease (GVHD), whether acute or chronic
- Are receiving any other chemotherapy or investigational therapy. Patients must have
been off prior AML therapy for at least 2-4 weeks prior to entering study.
- Have a psychiatric disorder that would interfere with consent, study participation,
or follow-up
- Have an active, uncontrolled infection
- Have any other severe concurrent disease, or have a history of serious organ
dysfunction or disease involving the heart, kidney, liver, or other organ system
- Have been diagnosed with another malignancy, unless disease-free for at least 5
years; patients with treated melanoma skin cancer, in situ carcinoma, or cervical
intraepithelial neoplasia, regardless of the 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 are eligible if hormonal therapy has been initiated or the malignancy has
been surgically removed.
- Have clinical evidence suggestive of central nervous system (CNS) involvement with
leukemia unless lumbar puncture confirms absence of leukemic blasts in the
cerebrospinal fluid(CSF)
- Known HIV positivity
- Are pregnant or lactating |
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| Study is available at: |
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Medical College of Wisconsin
Milwaukee, WI
United States
Primary Contact:
Medical Information
Email: medinfo@genzyme.com
Phone: 800-745-4447 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 15, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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