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Imatinib treatment of paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (EsPhALL2010): a prospective, intergroup, open-label, single-arm clinical trial

Authors :
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, C
Cazzaniga, G
Cavé, H
Bradtke, J
Conter, V
Saha, V
Schrappe, M
Grazia Valsecchi, M
Biondi, Andrea
Gandemer, Virginie
De Lorenzo, Paola
Cario, Gunnar
Campbell, Myriam
Castor, Anders
Pieters, Rob
Baruchel, André
Vora, Ajay
Leoni, Veronica
Stary, Jan
Escherich, Gabriele
Li, Chi-Kong
Cazzaniga, Giovanni
Cavé, Hélène
Bradtke, Jutta
Conter, Valentino
Saha, Vaskar
Schrappe, Martin
Grazia Valsecchi, Maria
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, C
Cazzaniga, G
Cavé, H
Bradtke, J
Conter, V
Saha, V
Schrappe, M
Grazia Valsecchi, M
Biondi, Andrea
Gandemer, Virginie
De Lorenzo, Paola
Cario, Gunnar
Campbell, Myriam
Castor, Anders
Pieters, Rob
Baruchel, André
Vora, Ajay
Leoni, Veronica
Stary, Jan
Escherich, Gabriele
Li, Chi-Kong
Cazzaniga, Giovanni
Cavé, Hélène
Bradtke, Jutta
Conter, Valentino
Saha, Vaskar
Schrappe, Martin
Grazia Valsecchi, Maria
Publication Year :
2018

Abstract

Background: The EsPhALL2004 randomised trial showed a 10% advantage in disease-free survival for short, discontinuous use of imatinib after induction compared with no use of imatinib in patients with Philadelphia chromosome-positive acute lymphoblastic leukaemia receiving Berlin-Frankfurt-Münster chemotherapy and haemopoietic stem-cell transplantation (HSCT). Other contemporary studies showed an advantage from continuous protracted exposure to imatinib, challenging the indications to transplant. The EsPhALL2010 study was designed to assess whether imatinib given from day 15 of induction and continuously throughout chemotherapy led to a different outcome to that obtained in EsPhALL2004, despite decreasing the number of patients having HSCT. Methods: This prospective, intergroup, open-label, single-arm clinical trial (EsPhALL2010) was done at 11 study groups across Europe, Chile, and Hong Kong. Patients aged 1–17 years with the translocation t(9;22)(q34;q11) who were recruited into national front-line trials for acute lymphoblastic leukaemia were eligible for this trial. Patients with abnormal renal or hepatic function or an active systemic infection were ineligible. Patients received imatinib 300 mg/m2 continuously from day 15 of induction during chemotherapy. Eligibility to HSCT depended on early morphological response and minimal residual disease. Imatinib was recommended throughout the first year after transplant. The co-primary endpoints were event-free survival and overall survival. All analyses were done in the intention-to-treat population. The trial is registered with the European Clinical Trials Database (EudraCT 2004-001647-30) and with ClinicalTrials.gov (NCT00287105) and is completed. Findings: 158 patients were screened for eligibility, of whom 155 were enrolled between Jan 1, 2010, and Dec 31, 2014. 151 (97%) patients achieved first complete remission after induction and four after the consolidation phase, with 102 (66%) patients categorised as good ri

Details

Database :
OAIster
Notes :
English
Publication Type :
Electronic Resource
Accession number :
edsoai.on1308928369
Document Type :
Electronic Resource