A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias. - NCT00315705- (Clinical Trial 140963)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy140963.aspx
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Seattle |
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State:
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WA |
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| Conditions: |
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Acute Lymphoblastic Leukemia - Acute Myelogenous Leukemia - Relapsed 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.
The purpose of this study is to determine if clofarabine added to a combination of etoposide
and cyclophosphamide is safe and effective in children with relapsed and refractory acute
lymphoblastic leukemia or acute myelogenous leukemia.
As of August 2007, this study is only recruiting patients for the Phase 2 portion of the
study.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- NOTE: the following eligibility criteria was applicable to ALL and AML patients for
the Phase I portion of this study; and is applicable to ALL patients only for the
Phase II portion of the study.
- ALL with > 25% blasts in bone marrow; AML with ≥ 5% blasts in bone marrow; ALL and
AML patients may have extramedullary disease
- Body weight > 10 kg
- KPS ≥ 50 for patients > 10 years old; LPS ≥ 50 for patients ≤ 10 years old
- Prior therapy: AML: 1-2 prior induction regimens and ≤ 1 hematopoietic stem cell
transplant (HSCT); ALL: 1-3 prior induction regimens
- Adequate liver, renal, pancreatic, and cardiac function
- Have received no prior HSCT
Exclusion Criteria:
- NOTE: the following eligibility criteria was applicable to ALL and AML patients for
the Phase I portion of this study; and is applicable to ALL patients only for the
Phase II portion of the study.
- Burkitt's leukemia (FAB L3-ALL)
- Previous treatment with clofarabine
- Uncontrolled systemic fungal, bacterial or other infection and afebrile 48 hrs prior
to enrollment
- Active CNS involvement (i.e., should be CNS1 or CNS2)
- Inadequate time since last therapy: ≤ 14 days since last cytotoxic chemotherapy; ≤ 7
days since last biologic therapy; ≤ 14 days since last monoclonal antibody therapy; ≤
4 months since HSCT
- Have received a HSCT
- Pregnant or lactating
- Have known hepatitis B or C infection or history of cirrhosis |
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| Study is available at: |
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Seattle Children's Hospital
Seattle, WA
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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