Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children

Rennes University Hospital49 enrolled

Overview

The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Lymphoblastic Leukemia Philadelphia Chromosome

Interventions

Standard chemotherapy + ImatinibDRUG

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

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Service d'hématologie pédiatrique CHRU

Amiens, France

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

Compare long term outcome between patients treated by BFM-chemotherapy and patient undergoing more intensive chemotherapy (protocole COGAALL0031 : Children Oncology Group-USA).

Time frame: 2 years

Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups.

Time frame: 2 years

Pattern of molecular response (MRD)

Time frame: 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.

Time frame: 2 years

Data from ClinicalTrials.gov

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