Status:
COMPLETED
A Phase II, Open-Label Study of Clofarabine in Paediatric Patients With Refractory/Relapsed Acute Lymphoblastic Leukaemia
Lead Sponsor:
Genzyme, a Sanofi Company
Collaborating Sponsors:
Bioenvision
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE2
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 s...
Detailed Description
Note: This clinical trial was conducted by Bioenvision Ltd. Bioenvision Ltd. was acquired by Genzyme Corporation Oct 2007.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00930098
Start Date
December 1 2003
End Date
July 1 2007
Last Update
February 11 2014
Active Locations (36)
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1
Vienna, Austria
2
Besançon, France
3
Bordeaux, France
4
Lille, France