Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children (ESPHALL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Rennes University Hospital
Sponsor:
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: July 23, 2014
Last verified: July 2014
  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 2016
Estimated Primary Completion Date: December 2016 (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:
  • Glivec
  • Gleevec
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:
  • Glivec
  • Gleevec

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 23, 2014
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 July 31, 2014