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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

Tracking Information
First Submitted Date  ICMJE February 3, 2006
First Posted Date  ICMJE February 6, 2006
Last Update Posted Date October 20, 2017
Actual Study Start Date  ICMJE December 2005
Actual Primary Completion Date March 30, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 17, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 3, 2006)
Disease Free Survival : time from randomization to relapse, death in complete remission (CR), second malignancies
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 17, 2012)
  • 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 ]
  • Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups. [ Time Frame: 2 years ]
  • Pattern of molecular response (MRD) [ Time Frame: 5 time points between S4 and S22 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2006)
  • - 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Lymphoblastic Leukemia
  • Philadelphia Chromosome
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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%.
    Intervention: Drug: Standard chemotherapy + Imatinib
  • 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%.
    Intervention: Drug: Standard chemotherapy + Imatinib
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2017)
49
Original Enrollment  ICMJE
 (submitted: February 3, 2006)
40
Actual Study Completion Date  ICMJE March 3, 2017
Actual Primary Completion Date March 30, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00287105
Other Study ID Numbers  ICMJE EUDRACT 2004-001647-30
PHRC/04-04
CIC0203/043
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rennes University Hospital
Study Sponsor  ICMJE Rennes University Hospital
Collaborators  ICMJE
  • Ministry of Health, France
  • Novartis
Investigators  ICMJE
Study Director: Andrea Biondi, MD Ospedale S. Gerardo - Monza
Principal Investigator: Virginie Gandemer, MD Rennes University Hospital
PRS Account Rennes University Hospital
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP