- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00930098
A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia
February 10, 2014 updated by: Genzyme, a Sanofi Company
This study is for a population of patients with few or no alternative options that was conducted to determine the response rate to clofarabine.
Additionally the study will provide information on the safety profile, impact of overall survival, and impact on remission duration with clofarabine.
It is a single arm study and has no comparator.
Study Overview
Detailed Description
Note: This clinical trial was conducted by Bioenvision Ltd.
Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria
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Besancon, France
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Bordeaux, France
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Lille, France
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Lyon, France
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Marseille, France
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Nantes, France
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Paris, France
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Toulouse, France
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Vandoeuvre-les-Nancy, France
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Berlin, Germany
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Dusseldorf, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hannover, Germany
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Kiel, Germany
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Muenster, Germany
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Munich, Germany
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Stuttgart, Germany
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Monza, Italy
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Pavia, Italy
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Amsterdam, Netherlands
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Groningen, Netherlands
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Leiden, Netherlands
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Rotterdam, Netherlands
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Utrecht, Netherlands
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Birmingham, United Kingdom
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Bristol, United Kingdom
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Glasgow, United Kingdom
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Leeds, United Kingdom
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Liverpool, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Sheffield, United Kingdom
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Sutton, United Kingdom
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 21 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Have a diagnosis of ALL and confirmed by pathologic assessment.
- 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:
- Received previous treatment with clofarabine.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Overall response rate after 1 course or more
Time Frame: minimum of 1 course and maximum of 12 courses
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minimum of 1 course and maximum of 12 courses
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Overall response rate after 2 courses or more
Time Frame: minimum of 2 courses and maximum of 12 courses
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minimum of 2 courses and maximum of 12 courses
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Rate of response (complete, complete with incomplete blood count recovery, partial) after 1 course or more
Time Frame: minimum of 1 course and maximum of 12 courses
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minimum of 1 course and maximum of 12 courses
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Time-to-event parameters including duration of remission and overall survival
Time Frame: Until death of patient or until end of study treatment for last enrolled patient
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Until death of patient or until end of study treatment for last enrolled patient
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Safety and tolerability
Time Frame: Until death of patient or until end of study treatment for last enrolled patient
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Until death of patient or until end of study treatment for last enrolled patient
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Number of patients received bone marrow or peripheral blood stem cell transplantation and the time to transplant following commencement of Clofarabine
Time Frame: Until death of patient or until end of study treatment for last enrolled patient
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Until death of patient or until end of study treatment for last enrolled patient
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Determine pharmacokinetic profile and intracellular triphosphate and levels of clofarabine
Time Frame: every day during the first course of treatment
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every day during the first course of treatment
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Document the metabolic pathways that may predict Clofarabine sensitivity or resistance
Time Frame: day 1, day 5, day 6 and day 7 of the first course
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day 1, day 5, day 6 and day 7 of the first course
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2003
Study Completion (ACTUAL)
July 1, 2007
Study Registration Dates
First Submitted
June 17, 2009
First Submitted That Met QC Criteria
June 29, 2009
First Posted (ESTIMATE)
June 30, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
February 11, 2014
Last Update Submitted That Met QC Criteria
February 10, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Leukemia
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Lymphoid
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Clofarabine
Other Study ID Numbers
- BIOV-111
- UKCCSG: NAG 2003 06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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