Acute Lymphoblastic Leukemia, Philadelphia Chromosome
Conditions
Keywords
Chemotherapy, Leukemia, Children, Philadelphia chromosome, Protein-tyrosine kinase inhibitor
Brief summary
The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.
Detailed description
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).
Interventions
DRUGStandard chemotherapy + Imatinib
Patients receive Imatinib together with the standard chemotherapy regimen of phase IB and after each of three consecutive blocks of the standard chemotherapy in the consolidation phase
Sponsors
Ministry of Health, France
Novartis
Rennes University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Compare long term outcome between patients treated by BFM-chemotherapy and patient undergoing more intensive chemotherapy (protocole COGAALL0031 : Children Oncology Group-USA). | 2 years |
| Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups. | 2 years |
| Pattern of molecular response (MRD) | 5 time points between S4 and S22 |
| Conversion rate to CR in patients resistant to the first part of the induction phase of chemotherapy included in the Poor-risk group. | 2 years |
Countries
France
Outcome results
None listed