Spots Global Cancer Trial Database for Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children
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Trial Identification
Brief Title: Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children
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)
Study ID: NCT00287105
Interventions
Study Description
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).
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Hématologie Pédiatrique - Hôpital Trousseau, Paris, , France
Hémato-immunologie-Robert Debré, 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, , France
Contact Details
Name: Andrea Biondi, MD
Affiliation: Ospedale S. Gerardo - Monza
Role: STUDY_DIRECTOR
Name: Virginie Gandemer, MD
Affiliation: Rennes University Hospital
Role: PRINCIPAL_INVESTIGATOR
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