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

NCT00287105 | Completed Phase 2 DMC

• 3 other identifiers: EUDRACT 2004-001647-30PHRC/04-04CIC0203/043
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 22

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.

Conditions

Acute Lymphoblastic Leukemia; Philadelphia Chromosome

Keywords

Chemotherapy; Leukemia; Children; Philadelphia chromosome; Protein-tyrosine kinase inhibitor

Outcome Measures

Primary Outcomes (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.

  2 years

Secondary Outcomes (4)

• Compare long term outcome between patients treated by BFM-chemotherapy and patient undergoing more intensive chemotherapy (protocole COGAALL0031 : Children Oncology Group-USA).

  2 years

• Long-term clinical outcome : Disease free survival (DFS), Event-Free Survival (EFS) and Overall Survival (OS) in each risk groups.

  2 years

• Pattern of molecular response (MRD)

  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.

  2 years

Study Arms (2)

Good risk Ph+ALL

OTHER

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

Poor risk Ph+ALL

OTHER

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

Interventions

Standard chemotherapy + Imatinib DRUG

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

Also known as: Glivec, Gleevec

Good risk Ph+ALL; Poor risk Ph+ALL

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Abnormal hepatic functions
• Abnormal renal functions
• Active systemic bacterial, fungal or viral infection

Sponsors & Collaborators

• Rennes University Hospital: lead
• Ministry of Health, France: collaborator
• Novartis: collaborator

Study Sites (22)

Service d'hématologie pédiatrique CHRU

Amiens, 80080, France

Location

Service hématologie pédiatrique Hôpital Saint-Jacques

Besançon, 25000, France

Location

Service d'hémato-oncologie - Hôpital des Enfants Pellegrin

Bordeaux, 33076, France

Location

Hôpital Morvan

Brest, 29200, France

Location

Hématologie oncologie pédiatrique-CHU Caen

Caen, France

Location

Hémato-Oncologie et Thérapie Cellulaire Pédiatrique - Hôtel Dieu

Clermont-Ferrand, 63058, France

Location

Hémato-Oncologie Pédiatrique - Hôpital d'Enfants

Dijon, 21034, France

Location

Pédiatrie CHU - Hôpital Nord

Grenoble, 38043, France

Location

Hôpital Jeanne de Flandre

Lille, 59037, France

Location

Limoges University Hospital

Limoges, 87042, France

Location

Hôpital DEBROUSSE Institut d'hématologie et d'oncologie pédiatrique

Lyon, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, France

Location

Hématologie Pédiatrique - Hôpital Trousseau

Paris, 75571, France

Location

Hémato-immunologie-Robert Debré

Paris, France

Location

Hématologie Hôpital Jean Bernard

Poitiers, 86021, France

Location

Hématologie pédiatrique-Hopital américain

Reims, France

Location

Service d'hématologie pédiatrique - Hôpital Sud

Rennes, 35033, France

Location

Service d'Immuno Hémato Oncologie Pédiatrique - Hôpital Charles Nicolle

Rouen, 76031, France

Location

Hématologie, Oncologie pédiatrique-CHU Saint Etienne

Saint-Etienne, France

Location

Hopital des enfants

Toulouse, France

Location

CHU- Centre Gatien de Clocheville

Tours, 37044, France

Location

Hôpital d'enfants

Vandœuvre-lès-Nancy, 54511, France

Location

Related Publications (3)

• 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, Arico M, Rottgers 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.

  PMID: 22898679 RESULT

• Biondi A, Gandemer V, De Lorenzo P, Cario G, Campbell M, Castor A, Pieters R, Baruchel A, Vora A, Leoni V, Stary J, Escherich G, Li CK, Cazzaniga G, Cave H, Bradtke J, Conter V, Saha V, Schrappe M, Grazia Valsecchi M. Imatinib treatment of paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (EsPhALL2010): a prospective, intergroup, open-label, single-arm clinical trial. Lancet Haematol. 2018 Dec;5(12):e641-e652. doi: 10.1016/S2352-3026(18)30173-X.

  PMID: 30501871 RESULT

• Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.

  PMID: 33242441 DERIVED

Related Links

• Primary Publication

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Philadelphia Chromosome; Leukemia

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Translocation, Genetic; Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Andrea Biondi, MD

  Ospedale S. Gerardo - Monza

  STUDY DIRECTOR

• Virginie Gandemer, MD

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2006
• First Posted: February 6, 2006
• Study Start: December 1, 2005
• Primary Completion: March 30, 2016
• Study Completion: March 3, 2017
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

FR (22)