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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00287105
Other study ID # EUDRACT 2004-001647-30
Secondary ID PHRC/04-04CIC020
Status Completed
Phase Phase 2
First received
Last updated
Start date December 2005
Est. completion date March 3, 2017

Study information

Verified date May 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date March 3, 2017
Est. primary completion date March 30, 2016
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Standard 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

Locations

Country Name City State
France Service d'hématologie pédiatrique CHRU Amiens
France Service hématologie pédiatrique Hôpital Saint-Jacques Besancon
France Service d'hémato-oncologie - Hôpital des Enfants Pellegrin Bordeaux
France Hôpital Morvan Brest
France Hématologie oncologie pédiatrique-CHU Caen Caen
France Hémato-Oncologie et Thérapie Cellulaire Pédiatrique - Hôtel Dieu Clermont-Ferrand
France Hémato-Oncologie Pédiatrique - Hôpital d'Enfants Dijon
France Pédiatrie CHU - Hôpital Nord Grenoble
France Hôpital Jeanne de Flandre Lille
France Limoges University Hospital Limoges
France Hôpital DEBROUSSE Institut d'hématologie et d'oncologie pédiatrique Lyon
France Hôpital Arnaud de Villeneuve Montpellier
France Hémato-immunologie-Robert Debré Paris
France Hématologie Pédiatrique - Hôpital Trousseau Paris
France Hématologie Hôpital Jean Bernard Poitiers
France Hématologie pédiatrique-Hopital américain Reims
France Service d'hématologie pédiatrique - Hôpital Sud Rennes
France Service d'Immuno Hémato Oncologie Pédiatrique - Hôpital Charles Nicolle Rouen
France Hématologie, Oncologie pédiatrique-CHU Saint Etienne Saint Etienne
France Hopital des enfants Toulouse
France CHU- Centre Gatien de Clocheville Tours
France Hôpital d'enfants Vandoeuvre Les Nancy

Sponsors (3)

Lead Sponsor Collaborator
Rennes University Hospital Ministry of Health, France, Novartis

Country where clinical trial is conducted

France, 

References & Publications (2)

Biondi A, Gandemer V, De Lorenzo P, Cario G, Campbell M, Castor A, Pieters R, Baruchel A, Vora A, Leoni V, Stary J, Escherich G, Li CK, Cazzaniga G, Cave H, Bradtke J, Conter V, Saha V, Schrappe M, Grazia Valsecchi M. Imatinib treatment of paediatric Phil — View Citation

Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Arico M, Rottgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelph — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Compare long term outcome between patients treated by BFM-chemotherapy and patient undergoing more intensive chemotherapy (protocole COGAALL0031 : Children Oncology Group-USA). 2 years
Secondary Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups. 2 years
Secondary Pattern of molecular response (MRD) 5 time points between S4 and S22
Secondary 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
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