Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children (ESPHALL)
This study is currently recruiting participants.
Verified September 2012 by Rennes University Hospital
Sponsor:
Rennes University Hospital
Collaborators:
Ministry of Health, France
Novartis
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00287105
First received: February 3, 2006
Last updated: September 17, 2012
Last verified: September 2012
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia Philadelphia Chromosome |
Drug: Standard chemotherapy + Imatinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Further study details as provided by Rennes University Hospital:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Pattern of molecular response (MRD) [ Time Frame: 5 time points between S4 and S22 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 110 |
| Study Start Date: | February 2006 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Good risk Ph+ALL
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%.
|
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
Other Names:
|
|
Poor risk Ph+ALL
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%.
|
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
Other Names:
|
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| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287105
Contacts
| 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 |
Locations
| France | |
| Service d'hématologie pédiatrique CHRU | Recruiting |
| Amiens, France, 80080 | |
| Contact: Brigitte Pautard, MD | |
| Principal Investigator: Brigitte Pautard, MD | |
| Service hématologie pédiatrique Hôpital Saint-Jacques | Recruiting |
| Besancon, France, 25000 | |
| Principal Investigator: Emmanuel Plouvier, 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 | |
| Hôpital Morvan | Recruiting |
| Brest, France, 29200 | |
| Contact: Berthou Christian, MD 33-2-9822-3504 ChristianBERTHOU@wanadoo.fr | |
| Principal Investigator: Berthou Christian, MD | |
| Hématologie oncologie pédiatrique-CHU Caen | Recruiting |
| Caen, France | |
| Contact: Odile Minckes | |
| Principal Investigator: Odile Minckes, MD | |
| Sub-Investigator: Bodet, 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 | |
| Dijon hôpital d'enfants | Recruiting |
| Dijon, France, 21034 | |
| Contact: Couillault Gérard, MD 33-3-8029-3324 gerard.couillault@chu-dijon.fr | |
| Principal Investigator: Couillault Gérard, 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 | |
| Pédiatrie CHU - Hôpital Nord | Recruiting |
| Grenoble, France, 38043 | |
| Principal Investigator: Dominique Plantaz, PUPH | |
| Hôpital Jeanne de Flandre | Recruiting |
| Lille, France, 59037 | |
| Contact: NELKEN Brigitte, MD 33-3-2044-5963 bnelken@chru-lille.fr | |
| Principal Investigator: NELKEN Brigitte, MD | |
| Sub-Investigator: Francoise Mazingue, MD | |
| Limoges University Hospital | Recruiting |
| Limoges, France, 87042 | |
| Contact: Piguet Christophe, MD,PhD 33-5-5505-6841 christophe.piguet@chu-limoges.fr | |
| Principal Investigator: Piguet Christophe, MD, PhD | |
| Hôpital DEBROUSSE Institut d'hématologie et d'oncologie pédiatrique | Recruiting |
| Lyon, France | |
| Contact: Yves Bertrand, MD | |
| Principal Investigator: Yves Bertrand, MD | |
| Service hématologie pédiatrique CHU la Timone | Recruiting |
| Maseille, France, 13385 | |
| Principal Investigator: Gerard Michel, MD | |
| Hôpital Arnaud de Villeneuve | Recruiting |
| Montpellier, France | |
| Contact: Nicolas Sirvent, MD 33-4.67.33.66.30 | |
| Principal Investigator: Nicolas Sirvent, MD | |
| CHR Hôtel Dieu | Recruiting |
| Nantes, France | |
| Contact: Fanny RIALLAND | |
| Principal Investigator: Fanny RIALLAND, MD | |
| Hôpital de l'Archet | Recruiting |
| Nice, France | |
| Contact: Chritine SOLER, MD 33-4.92.03.60.64 | |
| Principal Investigator: Christine Soler, MD | |
| Sub-Investigator: Maryline POIREE, MD | |
| Hémato-immunologie-Robert Debré | Recruiting |
| Paris, France | |
| Contact: André Baruchel, PhD 33-1 40 03 53 88 | |
| Principal Investigator: André Baruchel, PhD | |
| Sub-Investigator: VILMER, 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 hématologie Hopital Necker | Recruiting |
| Paris, France, 75015 | |
| Principal Investigator: Alain Fischer, PUPH | |
| Hématologie Hôpital Jean Bernard | Recruiting |
| Poitiers, France, 86021 | |
| Principal Investigator: Frédéric Millot, MD | |
| Hématologie pédiatrique-Hopital américain | Recruiting |
| Reims, France | |
| Contact: Martine MUNZER 33-3.26.78.75.15 | |
| Principal Investigator: Martine Munzer, MD | |
| Service d'hématologie pédiatrique - Hôpital Sud | Recruiting |
| Rennes, France, 35033 | |
| Contact: Virginie Gandemer, MD 33-2-9926-7162 virginie.gandemer@chu-rennes.fr | |
| Principal Investigator: Virginie Gandemer, MD | |
| Sub-Investigator: Celine Chappé, 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 | |
| Hématologie, Oncologie pédiatrique-CHU Saint Etienne | Recruiting |
| Saint Etienne, France | |
| Contact: Berger, MD | |
| Principal Investigator: Claire Berger, MD | |
| Sub-Investigator: Jean Louis Stephan, MD | |
| Sub-Investigator: Sandrine Thouvenin-Doulet, MD | |
| Pédiatrie Hôpital Hautepierre | Recruiting |
| Strasbourg, France, 67098 | |
| Principal Investigator: Patrick Lutz, PUPH | |
| Hopital des enfants | Recruiting |
| Toulouse, France | |
| Contact: Geneviève PLAT, MD 33-5-34-55-86-11 | |
| Principal Investigator: Geneviève Plat, MD | |
| CHU- Centre Gatien de Clocheville | Recruiting |
| Tours, France, 37044 | |
| Principal Investigator: Odile Lejars, MD | |
| Hôpital d'enfants | Recruiting |
| Vandoeuvre Les Nancy, France, 54511 | |
| Contact: Claudine Schmitt, MD 33-3.83.15.45.50 | |
| Principal Investigator: Claudine Schmitt, MD | |
| Sub-Investigator: Aurélie Chaumont, MD | |
Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Novartis
Investigators
| Study Director: | Andrea Biondi, MD | Ospedale S. Gerardo - Monza |
| Principal Investigator: | Virginie Gandemer, MD | Rennes University Hospital |
More Information
No publications provided by Rennes University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00287105 History of Changes |
| Other Study ID Numbers: | EUDRACT 2004-001647-30, PHRC/04-04, CIC0203/043 |
| Study First Received: | February 3, 2006 |
| Last Updated: | September 17, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Rennes University Hospital:
|
Chemotherapy Leukemia Children Philadelphia chromosome Protein-tyrosine kinase inhibitor |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Translocation, Genetic Chromosome Aberrations Pathologic Processes Imatinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013