title: Higher dose imatinib for children with de novo chronic phase chronic myelogenous leukemia: a report from the Children's Oncology Group.
abstract: OBJECTIVE
  To determine the efficacy of imatinib in children with newly diagnosed chronic phase (CP) chronic myelogenous leukemia (CML).
  
  
  METHODS
  This was an open label, multi-center phase II clinical trial. Courses were defined as consecutive 28-day intervals. Oral imatinib was administered daily at 340 mg/m² without interruption in the absence of toxicity.
  
  
  RESULTS
  Fifty-one children received 978 28-day courses of imatinib. The most common toxicities encountered were hematologic. Forty-one patients (80%) achieved a complete hematologic response by the end of course 2. Nineteen children (38%) obtained a complete cytogenetic response (CCyR) at the end of course 3. Overall, 72% achieved CCyR at a median time of 5.6 months. The rate of complete molecular response (>3 log reduction) was 27%. Progression-free and overall survival at 3 years were 72%  ± 6.4% and 92%  ± 3.9%, respectively.
  
  
  CONCLUSIONS
  Daily oral imatinib at a dose of 340 mg/m² is well tolerated in children. In addition, imatinib therapy is effective in inducing a high percent of hematologic, cytogenetic and molecular responses, comparable to adults with CML. (This study was registered at ClinicalTrials.gov under identifier NCT00030394.).
authors.affiliation: Centre Hospitalier Universitaire Sainte-Justine, Montréal, Québec, Canada. martin.a.champagne@umontreal.ca
authors.forename: Martin A
authors.initials: MA
authors.lastname: Champagne
authors.forename: Cecilia H
authors.initials: CH
authors.lastname: Fu
authors.forename: Myron
authors.initials: M
authors.lastname: Chang
authors.forename: Helen
authors.initials: H
authors.lastname: Chen
authors.forename: Robert B
authors.initials: RB
authors.lastname: Gerbing
authors.forename: Todd A
authors.initials: TA
authors.lastname: Alonzo
authors.forename: Linda D
authors.initials: LD
authors.lastname: Cooley
authors.forename: Nyla A
authors.initials: NA
authors.lastname: Heerema
authors.forename: Vivian
authors.initials: V
authors.lastname: Oehler
authors.forename: Charlotte
authors.initials: C
authors.lastname: Wood
authors.forename: Mary Ellen
authors.initials: ME
authors.lastname: French
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Arceci
authors.forename: Franklin O
authors.initials: FO
authors.lastname: Smith
authors.forename: Mark L
authors.initials: ML
authors.lastname: Bernstein
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001549:Benzamides; D002648:Child; D002675:Child, Preschool; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D000068877:Imatinib Mesylate; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D012074:Remission Induction; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate