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Efficacy and safety of imatinib on top of BFM-like chemotherapy in pediatric patients with Ph+/BCR-ABL+ acute lymphoblastic leukemia (Ph+ALL). the EsPhALL study

Biondi, Andrea ; Schrappe, Martin ; De Lorenzo, Paola ; Castor, Anders LU ; Lucchini, Giovanna ; Gandemer, Virginie ; Pieters, Rob ; Stary, Jan ; Escherich, Gabriele and Campbell, Myriam , et al. (2011) 53rd Annual Meeting of the American Society of Hematology In Blood 118(21).
Abstract
Background. Philadelphia chromosome positive (Ph+) ALL accounts for 3-5% of pediatric ALL. An international survey on 640 children diagnosed between 1995 and 2005 and treated with chemotherapy and stem cell transplantation (SCT) without the use of tyrosin kinase inhibitors (TKI) recently reported an overall 7-year event free survival (EFS) and overall survival (OS) of 31.2% and 44.2%, respectively. In those years, only limited experience was accumulated on the use of Imatinib (IM) for children with Ph+ leukemia. The EsPhALL study was designed as an intergroup, open-label, randomized Phase II/III study, within the I-BFM-SG network, to assess the safety and efficacy of IM in association with chemotherapy. Ten national study groups... (More)
Background. Philadelphia chromosome positive (Ph+) ALL accounts for 3-5% of pediatric ALL. An international survey on 640 children diagnosed between 1995 and 2005 and treated with chemotherapy and stem cell transplantation (SCT) without the use of tyrosin kinase inhibitors (TKI) recently reported an overall 7-year event free survival (EFS) and overall survival (OS) of 31.2% and 44.2%, respectively. In those years, only limited experience was accumulated on the use of Imatinib (IM) for children with Ph+ leukemia. The EsPhALL study was designed as an intergroup, open-label, randomized Phase II/III study, within the I-BFM-SG network, to assess the safety and efficacy of IM in association with chemotherapy. Ten national study groups participated in the study: AIEOP, BFM-G/CH, COALL, FRALLE, NOPHO, MRC, DCOG, CPH, PINDA and HONG KONG. Methods. Patients 1 to 18 years of age diagnosed with Ph+ ALL were eligible to the study. After the induction phase according to national treatment protocol, patients were classified as Good Risk (GR) or Poor Risk (PR) according to their response to treatment. GR patients were those who achieved both the early response (i.e. blast cell count (Less)
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publishing date
type
Contribution to journal
publication status
published
keywords
imatinib, tyrosine, phosphotransferase inhibitor, prednisone, methotrexate, hemoglobin, human, pH, patient, acute lymphoblastic leukemia, society, chemotherapy, hematology, safety, arm, risk, donor, remission, child, bone marrow, single drug dose, stem cell transplantation, randomization, Philadelphia chromosome positive cell, blood, thrombocyte, cell count, granulocyte, leukocyte, blast cell, intrathecal drug administration, leukemia, relapse, overall survival, log rank test, disease free survival, death, allele, genotype, event free survival, infection
in
Blood
volume
118
issue
21
article number
Abstract 873
publisher
American Society of Hematology
conference name
53rd Annual Meeting of the American Society of Hematology
conference location
San Diego, United States
conference dates
2011-12-10 - 2011-12-13
ISSN
1528-0020
language
English
LU publication?
no
id
8be75c3f-5dbc-4519-9733-9a843dad7155
date added to LUP
2017-09-10 22:04:51
date last changed
2023-04-18 17:46:11
@misc{8be75c3f-5dbc-4519-9733-9a843dad7155,
  abstract     = {{Background. Philadelphia chromosome positive (Ph+) ALL accounts for 3-5% of pediatric ALL. An international survey on 640 children diagnosed between 1995 and 2005 and treated with chemotherapy and stem cell transplantation (SCT) without the use of tyrosin kinase inhibitors (TKI) recently reported an overall 7-year event free survival (EFS) and overall survival (OS) of 31.2% and 44.2%, respectively. In those years, only limited experience was accumulated on the use of Imatinib (IM) for children with Ph+ leukemia. The EsPhALL study was designed as an intergroup, open-label, randomized Phase II/III study, within the I-BFM-SG network, to assess the safety and efficacy of IM in association with chemotherapy. Ten national study groups participated in the study: AIEOP, BFM-G/CH, COALL, FRALLE, NOPHO, MRC, DCOG, CPH, PINDA and HONG KONG. Methods. Patients 1 to 18 years of age diagnosed with Ph+ ALL were eligible to the study. After the induction phase according to national treatment protocol, patients were classified as Good Risk (GR) or Poor Risk (PR) according to their response to treatment. GR patients were those who achieved both the early response (i.e. blast cell count}},
  author       = {{Biondi, Andrea and Schrappe, Martin and De Lorenzo, Paola and Castor, Anders and Lucchini, Giovanna and Gandemer, Virginie and Pieters, Rob and Stary, Jan and Escherich, Gabriele and Campbell, Myriam and Kong-Li, Ci and Vora, Ajay J. and Lonnerholm, Gudmar and Arico, Maurizio and Harbott, Jochen and Saha, Vaskar and Valsecchi, Maria Grazia}},
  issn         = {{1528-0020}},
  keywords     = {{imatinib; tyrosine; phosphotransferase inhibitor; prednisone; methotrexate; hemoglobin; human; pH; patient; acute lymphoblastic leukemia; society; chemotherapy; hematology; safety; arm; risk; donor; remission; child; bone marrow; single drug dose; stem cell transplantation; randomization; Philadelphia chromosome positive cell; blood; thrombocyte; cell count; granulocyte; leukocyte; blast cell; intrathecal drug administration; leukemia; relapse; overall survival; log rank test; disease free survival; death; allele; genotype; event free survival; infection}},
  language     = {{eng}},
  month        = {{11}},
  note         = {{Conference Abstract}},
  number       = {{21}},
  publisher    = {{American Society of Hematology}},
  series       = {{Blood}},
  title        = {{Efficacy and safety of imatinib on top of BFM-like chemotherapy in pediatric patients with Ph+/BCR-ABL+ acute lymphoblastic leukemia (Ph+ALL). the EsPhALL study}},
  volume       = {{118}},
  year         = {{2011}},
}