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 December 2013 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: December 24, 2013
Last verified: December 2013

February 3, 2006
December 24, 2013
February 2006
December 2013   (final data collection date for primary outcome measure)
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 ]
Disease Free Survival : time from randomization to relapse, death in complete remission (CR), second malignancies
Complete list of historical versions of study NCT00287105 on ClinicalTrials.gov Archive Site
  • 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 ]
  • - 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.
Not Provided
Not Provided
 
Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children
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)

The purpose of this study is to determine whether Imatinib is safe and effective in association with intensive treatment of Ph+ALL in children.

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).

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Lymphoblastic Leukemia
  • Philadelphia Chromosome
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
  • 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
Biondi A, Schrappe M, De Lorenzo P, Castor A, Lucchini G, Gandemer V, Pieters R, Stary J, Escherich G, Campbell M, Li CK, Vora A, Aricò M, Röttgers S, Saha V, Valsecchi MG. Imatinib after induction for treatment of children and adolescents with Philadelphia-chromosome-positive acute lymphoblastic leukaemia (EsPhALL): a randomised, open-label, intergroup study. Lancet Oncol. 2012 Sep;13(9):936-45. doi: 10.1016/S1470-2045(12)70377-7. Epub 2012 Aug 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
1 Year to 18 Years
No
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
France
 
NCT00287105
EUDRACT 2004-001647-30, PHRC/04-04, CIC0203/043
Yes
Rennes University Hospital
Rennes University Hospital
  • Ministry of Health, France
  • Novartis
Study Director: Andrea Biondi, MD Ospedale S. Gerardo - Monza
Principal Investigator: Virginie Gandemer, MD Rennes University Hospital
Rennes University Hospital
December 2013

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