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| Sponsors and Collaborators: |
Rennes University Hospital Ministry of Health, France Novartis |
|---|---|
| Information provided by: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00287105 |
Purpose
The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children. Patients will be randomized to receive or not Imatinib in addition to chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia Philadelphia Chromosome |
Drug: Imatinib |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | An Open-Label, Randomized Phase II/III Study to Compare the Safety and Efficacy of Imatinib With Chemotherapy in Pediatric Patients With Ph+ / BCR-ABL+ Acute Lymphoblastic Leukemia (Ph+ALL) |
| Estimated Enrollment: | 40 |
| Study Start Date: | February 2006 |
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 be stratified as Good-risk and Poor-risk, according to their initial prednisone and chemotherapy responses and the achievement of the complete remission at day 28. The Good-risk patients will be randomized to receive or not Imatinib whereas all Poor-risk patients 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| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Virginie Gandemer, MD | 33-2-9926-7162 | virginie.gandemer@chu-rennes.fr |
| Contact: Eric Bellissant, MD, PhD | 33-2-9928-9200 | eric.bellissant@chu-rennes.fr |
| France | |
| Service d'hématologie pédiatrique - Hôpital Sud | Not yet recruiting |
| Rennes, France, 35033 | |
| Contact: Virginie Gandemer, MD 33-2-9926-7162 virginie.gandemer@chu-rennes.fr | |
| Principal Investigator: Virginie Gandemer, MD | |
| Hématologie Pédiatrique - Hôpital Trousseau | Recruiting |
| Paris, France, 75571 | |
| Contact: Guy Leverger, MD 33-1-4473-6062 guy.leverger@trs.aphp.fr | |
| Principal Investigator: Guy Leverger, MD | |
| Sub-Investigator: Adjaoud, MD | |
| Service d'Immuno Hémato Oncologie Pédiatrique - Hôpital Charles Nicolle | Recruiting |
| Rouen, France, 76031 | |
| Contact: Jean-Pierre Vannier, MD 33-2-3288-8191 jean-pierre.vannier@chu-rouen.fr | |
| Principal Investigator: Jean-Pierre Vannier, MD | |
| Sub-Investigator: Aude Marie-Cardine, MD | |
| Hémato-Oncologie et Thérapie Cellulaire Pédiatrique - Hôtel Dieu | Recruiting |
| Clermont-Ferrand, France, 63058 | |
| Contact: François Demeocq, MD 33-4-7331-6014 fdemeocq@chu-clermontferrand.fr | |
| Principal Investigator: François Demeocq, MD | |
| Sub-Investigator: Etienne Merlin, MD | |
| Study Director: | Andrea Biondi, MD | Ospedale S. Gerardo - Monza |
| Principal Investigator: | Virginie Gandemer, MD | Rennes University Hospital |
More Information
| Study ID Numbers: | EUDRACT 2004-001647-30, PHRC/04-04, CIC0203/043 |
| Study First Received: | February 3, 2006 |
| Last Updated: | May 7, 2007 |
| ClinicalTrials.gov Identifier: | NCT00287105 History of Changes |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
|
Chemotherapy Leukemia Children Philadelphia chromosome Protein-tyrosine kinase inhibitor |
|
Philadelphia Chromosome Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Tyrosine Protein Kinase Inhibitors Imatinib |
Leukemia Lymphatic Diseases Chromosome Aberrations Lymphoproliferative Disorders Lymphoma Acute Lymphoblastic Leukemia |
|
Philadelphia Chromosome Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Translocation, Genetic Imatinib Leukemia Lymphatic Diseases Neoplasms Pathologic Processes Therapeutic Uses Chromosome Aberrations Lymphoproliferative Disorders |