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| Sponsor: | Rennes University Hospital |
|---|---|
| Collaborators: |
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: Standard chemotherapy + Imatinib Drug: Standard chemotherapy |
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 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Imatinib: Experimental |
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
|
| No imatinib: No Intervention |
Drug: Standard chemotherapy
Patients do not 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
|
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 Pédiatrique - Hôpital d'Enfants | Recruiting |
| Dijon, France, 21034 | |
| Contact: Gérard Couillault, MD 33-3-8029-3324 gerard.couillault@chu-dijon.fr | |
| Principal Investigator: Gérard Couillault, MD | |
| Sub-Investigator: Claire Briandet, MD | |
| Service d'hémato-oncologie - Hôpital des Enfants Pellegrin | Recruiting |
| Bordeaux, France, 33076 | |
| Contact: Yves Perel, MD 33-5-5679-5962 | |
| Principal Investigator: Yves Perel, MD | |
| Sub-Investigator: Cécile Verite, 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
| Responsible Party: | Rennes University Hospital ( Direction of Clinical Research ) |
| Study ID Numbers: | EUDRACT 2004-001647-30, PHRC/04-04, CIC0203/043 |
| Study First Received: | February 3, 2006 |
| Last Updated: | August 19, 2009 |
| 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 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 |
