A Study of Clofarabine in Combination With Etoposide and Cyclophosphamide in Children With Acute Leukemias.
NCT ID: NCT00315705
Last Updated: 2014-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2006-03-31
2010-05-31
Brief Summary
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The purpose of the phase 1 portion of this study was to determine if clofarabine added to a combination of etoposide and cyclophosphamide is safe in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or acute myelogenous leukemia (AML). The purpose of the phase 2 portion of the study was to measure the effectiveness of the combination therapy in children with ALL.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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clofarabine, etoposide, cyclophosphamide
Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m\^2, etoposide dosage from 75-100 mg/m\^2, cyclophosphamide dosage from 340-440 mg/m\^2.
Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m\^2, etoposide 100 mg/m\^2 and cyclophosphamide 440 mg/m\^2 delivered intravenously
clofarabine
Clofarabine 20-40 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle as the first of the three IV interventions administered. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Etoposide
Etoposide 75-100 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle following clofarabine therapy. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Cyclophosphamide
Cyclophosphamide 340-440 mg/m²/day as 30-60 minute intravenous (IV) infusion daily for 5 days of a 28 day cycle following the other two interventions. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Interventions
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clofarabine
Clofarabine 20-40 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle as the first of the three IV interventions administered. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Etoposide
Etoposide 75-100 mg/m²/day 2 hour intravenous (IV) infusion daily for 5 days of a 28 day cycle following clofarabine therapy. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Cyclophosphamide
Cyclophosphamide 340-440 mg/m²/day as 30-60 minute intravenous (IV) infusion daily for 5 days of a 28 day cycle following the other two interventions. Maximum of 8 cycles given in both the phase 1 and phase 2 study periods.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ALL with \> 25% blasts in bone marrow; AML with ≥ 5% blasts in bone marrow; ALL and AML patients may have extramedullary disease
* Karnofsky Performance Status ≥ 50 for patients \> 10 years old; Lansky Performance Status ≥ 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 (study amended in Phase 2 to exclude patients with prior HSCT)
Exclusion Criteria
* Burkitt's leukemia
* Previous treatment with clofarabine
* Uncontrolled systemic fungal, bacterial or other infection and 48 hrs negative blood cultures required for patients with a history of fever within 3 days of 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
* Have received prior HSCT (study amended in Phase 2 to exclude patients with prior HSCT)
* Pregnant or lactating
* Have tested positive for hepatitis B or hepatitis C infection or history of cirrhosis
1 Year
21 Years
ALL
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Children's Hospital of Alabama
Birmingham, Alabama, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Rady Children's Hospital
San Diego, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Children's Memorial Hospital
Chicago, Illinois, United States
St. Vincent Children's Hospital
Indianapolis, Indiana, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
New York School of Medicine
New York, New York, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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References
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Hijiya N, Thomson B, Isakoff MS, Silverman LB, Steinherz PG, Borowitz MJ, Kadota R, Cooper T, Shen V, Dahl G, Thottassery JV, Jeha S, Maloney K, Paul JA, Barry E, Carroll WL, Gaynon PS. Phase 2 trial of clofarabine in combination with etoposide and cyclophosphamide in pediatric patients with refractory or relapsed acute lymphoblastic leukemia. Blood. 2011 Dec 1;118(23):6043-9. doi: 10.1182/blood-2011-08-374710. Epub 2011 Oct 3.
Other Identifiers
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CLO21800205
Identifier Type: -
Identifier Source: org_study_id
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