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A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias. - NCT00315705-(Clinical Trial 140963)



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City:  Seattle
State:  
WA
Zip Code:
Conditions: Acute Lymphoblastic Leukemia - Acute Myelogenous Leukemia - Relapsed Leukemia
Purpose: 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.
Study summary:
Criteria: 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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Data Source: ClinicalTrials.gov
Date Processed: January 18, 2010
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