A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia
2 other identifiers
interventional
74
6 countries
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2003
Typical duration for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 17, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedFebruary 11, 2014
February 1, 2014
June 17, 2009
February 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate after 1 course or more
minimum of 1 course and maximum of 12 courses
Secondary Outcomes (7)
Overall response rate after 2 courses or more
minimum of 2 courses and maximum of 12 courses
Rate of response (complete, complete with incomplete blood count recovery, partial) after 1 course or more
minimum of 1 course and maximum of 12 courses
Time-to-event parameters including duration of remission and overall survival
Until death of patient or until end of study treatment for last enrolled patient
Safety and tolerability
Until death of patient or until end of study treatment for last enrolled patient
Number of patients received bone marrow or peripheral blood stem cell transplantation and the time to transplant following commencement of Clofarabine
Until death of patient or until end of study treatment for last enrolled patient
- +2 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genzyme, a Sanofi Companylead
- Bioenvisioncollaborator
Study Sites (36)
Unknown Facility
Vienna, Austria
Unknown Facility
Besançon, France
Unknown Facility
Bordeaux, France
Unknown Facility
Lille, France
Unknown Facility
Lyon, France
Unknown Facility
Marseille, France
Unknown Facility
Nantes, France
Unknown Facility
Paris, France
Unknown Facility
Toulouse, France
Unknown Facility
Vandœuvre-lès-Nancy, France
Unknown Facility
Berlin, Germany
Unknown Facility
Düsseldorf, Germany
Unknown Facility
Frankfurt, Germany
Unknown Facility
Hamburg, Germany
Unknown Facility
Hanover, Germany
Unknown Facility
Kiel, Germany
Unknown Facility
Munich, Germany
Unknown Facility
Münster, Germany
Unknown Facility
Stuttgart, Germany
Unknown Facility
Monza, Italy
Unknown Facility
Pavia, Italy
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Groningen, Netherlands
Unknown Facility
Leiden, Netherlands
Unknown Facility
Rotterdam, Netherlands
Unknown Facility
Utrecht, Netherlands
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
Bristol, United Kingdom
Unknown Facility
Glasgow, United Kingdom
Unknown Facility
Leeds, United Kingdom
Unknown Facility
Liverpool, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Newcastle upon Tyne, United Kingdom
Unknown Facility
Sheffield, United Kingdom
Unknown Facility
Sutton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 17, 2009
First Posted
June 30, 2009
Study Start
December 1, 2003
Study Completion
July 1, 2007
Last Updated
February 11, 2014
Record last verified: 2014-02