drugset / Trial / NCT00287105
Safety and Efficacy of Imatinib Added to Chemotherapy in Treatment of Ph+ Acute Lymphoblastic Leukemia in Children
Phase 2
Completed
49 enrolled
Rennes University Hospital
Ministry of Health, France · collabNovartis · collab
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2005-12
- Primary completion
- 2016-03-30
- Completion
- 2017-03-03
Outcome
Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)
paper The primary endpoints were disease-free survival at 4 years in the good-risk group and event-free survival at 4 years in the poor-risk group PMID 22898679 ↗
paper 4-year event-free survival for poor-risk patients was 53·5% (40·4-65·0). PMID 22898679 ↗
Publications
- Results 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.
- Results 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Imatinib | Small molecule | 300 mg/m2 | Oral |