Overview

This trial is active, not recruiting.

Conditions acute lymphoblastic leukemia, philadelphia chromosome
Treatment standard chemotherapy + imatinib
Phase phase 2
Sponsor Rennes University Hospital
Collaborator Ministry of Health, France
Start date February 2006
End date December 2016
Trial size 110 participants
Trial identifier NCT00287105, CIC0203/043, EUDRACT 2004-001647-30, PHRC/04-04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
For protocols which adopt a steroid prephase: patients who are Prednisone-good responder and achieve CR after the induction course. For protocols which do not adopt steroid prephase: patients who have M1/M2 BM at day 15 or M1 BM at day 21 and achieve CR after the induction course. Expected stratification in this group: 70-75%.
standard chemotherapy + imatinib Glivec
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
(Other)
For protocols which adopt a steroid prephase: patients who are Prednisone poor-responders. For protocol which do not adopt a steroid prephase: patients who have M3 BM at day 15 or M2/M3 BM at day 21. For all protocols: patients who do not achieve CR after the induction course. Expected stratification: 25-30%.
standard chemotherapy + imatinib Glivec
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

Primary Outcomes

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.
time frame: 2 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 1 year up to 18 years old.

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

Additional Information

Official title 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)
Principal investigator Virginie Gandemer, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Rennes University Hospital.