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

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ClinicalTrials.gov Identifier: NCT00287105
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : October 20, 2017
Sponsor:
Collaborators:
Ministry of Health, France
Novartis
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Philadelphia Chromosome Drug: Standard chemotherapy + Imatinib Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Actual Study Start Date : December 2005
Actual Primary Completion Date : March 30, 2016
Actual Study Completion Date : March 3, 2017

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups. [ Time Frame: 2 years ]
  3. Pattern of molecular response (MRD) [ Time Frame: 5 time points between S4 and S22 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00287105


Locations
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Sponsors and Collaborators
Rennes University Hospital
Ministry of Health, France
Novartis
Investigators
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Study Director: Andrea Biondi, MD Ospedale S. Gerardo - Monza
Principal Investigator: Virginie Gandemer, MD Rennes University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00287105    
Other Study ID Numbers: EUDRACT 2004-001647-30
PHRC/04-04
CIC0203/043
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: February 2017
Keywords provided by Rennes University Hospital:
Chemotherapy
Leukemia
Children
Philadelphia chromosome
Protein-tyrosine kinase inhibitor
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Philadelphia Chromosome
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Translocation, Genetic
Chromosome Aberrations
Pathologic Processes
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action