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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 by Rennes University Hospital, May 2007

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

MedlinePlus related topics:   Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood   

Drug Information available for:   Imatinib    Imatinib mesylate    Tyrosine   

U.S. FDA Resources

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)

Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • Disease Free Survival : time from randomization to relapse, death in complete remission (CR), second malignancies

Secondary Outcome Measures:
  • To Determine the safety and feasibility of Imatinib added to chemotherapy,
  • To Evaluate the long-term clinical outcome (EFS, survival) in both groups,
  • To Assess the antileukemic potential of Imatinib by analyzing the pattern by arm of the molecular response on the basis of 5 measurements of minimal residual disease (MRD) taken at 5 time points between S4 and S22,
  • To evaluate the role of molecular response as surrogate for DFS.

Estimated Enrollment:   40
Study Start Date:   February 2006

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 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

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 - 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            

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


Study ID Numbers:   EUDRACT 2004-001647-30, PHRC/04-04, CIC0203/043
First Received:   February 3, 2006
Last Updated:   May 7, 2007
ClinicalTrials.gov Identifier:   NCT00287105
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by Rennes University Hospital:
Chemotherapy  
Leukemia  
Children  
Philadelphia chromosome  
Protein-tyrosine kinase inhibitor  

Study placed in the following topic categories:
Imatinib
Chromosomal abnormalities
Philadelphia Chromosome
Lymphatic Diseases
Leukemia
Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Chromosome Aberrations
Lymphoproliferative Disorders
Lymphoma

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Translocation, Genetic

ClinicalTrials.gov processed this record on November 30, 2008




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