A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia
NCT ID: NCT00930098
Last Updated: 2014-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2003-12-31
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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clofarabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Be ≤ 21 years old at time of initial diagnosis.
* Eligible patients must have: Primary refractory disease; OR relapsed or refractory disease after a minimum of 2 prior blocks of treatment.
* Must not be eligible for therapy of higher curative potential.
* Have a Karnofsky Performance Status of ≥ 50 or Lansky Performance Scale of ≥ 30.
* Provide a signed, written informed consent from parent or guardian or young adult patients.
* Be able to comply with study procedures and follow-up examinations.
* Have adequate cardiac function without treatment.
* Have adequate organ function as indicated by the laboratory values for serum creatinine, serum bilirubin, AST and ALT, obtained within 7 days prior to registration.
Exclusion Criteria
* Patients with isolated extramedullary disease.
* Have received prior BMT or PBSCT within the last 6 months.
* Have received prior BMT or PBSCT more than 6 months ago, but now has compromised organ function.
* Have an active, uncontrolled systemic infection.
* Are pregnant or lactating. Male and female patients who are fertile must agree to use an effective means of birth control to avoid pregnancy.
* Have a psychiatric disorder that would interfere with consent, study participation, or follow-up.
* Have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity oa all previous therapy prior to enrollment.
* Have any other severe concurrent disease.
* Have recent history of significant renal, hepatic or pulmonary dysfunction, or cardiac dysfunction or on treatment to support cardiac function.
* Have CNS disease.
21 Years
ALL
No
Sponsors
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Bioenvision
INDUSTRY
Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Genzyme Corporation
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
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Vienna, , Austria
Besançon, , France
Bordeaux, , France
Lille, , France
Lyon, , France
Marseille, , France
Nantes, , France
Paris, , France
Toulouse, , France
Vandœuvre-lès-Nancy, , France
Berlin, , Germany
Düsseldorf, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Hanover, , Germany
Kiel, , Germany
Munich, , Germany
Münster, , Germany
Stuttgart, , Germany
Monza, , Italy
Pavia, , Italy
Amsterdam, , Netherlands
Groningen, , Netherlands
Leiden, , Netherlands
Rotterdam, , Netherlands
Utrecht, , Netherlands
Birmingham, , United Kingdom
Bristol, , United Kingdom
Glasgow, , United Kingdom
Leeds, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Sheffield, , United Kingdom
Sutton, , United Kingdom
Countries
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Other Identifiers
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UKCCSG: NAG 2003 06
Identifier Type: -
Identifier Source: secondary_id
BIOV-111
Identifier Type: -
Identifier Source: org_study_id
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