An Open-label, Phase II Study to Explore the Safety and Efficacy of Imatinib With Chemotherapy in Pediatric Patients With Ph+ / BCR-ABL+ Acute Lymphoblastic Leukemia (Ph+ALL)
1 Year
18 Years
Both
Acute Lymphoblastic Leukemia, Philadelphia Chromosome
Trial Information
An Open-label, Phase II Study to Explore the Safety and Efficacy of Imatinib With Chemotherapy in Pediatric Patients With Ph+ / BCR-ABL+ Acute Lymphoblastic Leukemia (Ph+ALL)
Recent advances in treatment have increased the cure of childhood ALL to 75% or better.
However, attempts to improve results for resistant subtypes of ALL, such as Ph+ ALL, have
been largely unsuccessful. Imatinib, an inhibitor of protein-tyrosine kinases, is currently
being tested in several phase I, II and III trials covering most Chronic Myeloid Leukemia
patient populations and patients with overtly relapsed or refractory Ph+ALL. Pediatric
patients with Ph+ALL will receive Imatinib, added to intensive, post-induction BFM-type
chemotherapy. The endpoint will be the evaluation on the long-term clinical outcome, in
particular on the Disease Free Survival (DFS).
Inclusion Criteria:
- Children and adolescents aged 1 to 17 years at diagnostic
- Documented Ph+ ALL
- Eligibility for the current local prospective therapeutic study of childhood ALL
- Informed consent given by the parents or by legal guardian
Exclusion Criteria:
- Abnormal hepatic functions
- Abnormal renal functions
- Active systemic bacterial, fungal or viral infection
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease free survival (DFS). DFS will be calculated as the time from inclusion to either one of the following events: relapse, death in CCR, second malignancies.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Andrea Biondi, MD
Investigator Role:
Study Director
Investigator Affiliation:
Ospedale S. Gerardo - Monza
Authority:
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study ID:
EUDRACT 2004-001647-30
NCT ID:
NCT00287105
Start Date:
February 2006
Completion Date:
December 2013
Related Keywords:
- Acute Lymphoblastic Leukemia
- Philadelphia Chromosome
- Chemotherapy
- Leukemia
- Children
- Philadelphia chromosome
- Protein-tyrosine kinase inhibitor
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Philadelphia Chromosome
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