Clinical Trial: Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)

Study Status: Suspended
Recruit Status: Suspended
Study Type: Interventional

Official Title: Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+)

Brief Summary: The purpose of this study is to evaluate the efficacy, through molecular response and event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM "like" Induction in children with ALL Ph+.

Detailed Summary:
Sponsor: Renato Melaragno

Current Primary Outcome: Evaluate the efficacy, through molecular response and event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM "like" Induction in children with ALL Ph+. [ Time Frame: Up to 24 months. ]

Cytogenetic and molecular response will be evaluate at the end of Induction I (D33), before each consolidation block (HR 1, 2 and 3), before re-induction, before maintenanceand at the end of therapy.


Original Primary Outcome: Evaluate the efficacy, through molecular response and event-free survival, about the use of Imatinib in conjunction with chemotherapy after BFM "like" Induction in children with ALL Ph+. [ Time Frame: Up to 24 months. ]

Current Secondary Outcome: Evaluate toxicity and tolerability in the administration of Imatinib in conjunction with chemotherapy in children with ALL Ph+. [ Time Frame: Up to 24 months ]

Toxicity and tolerability will be verified in every visit according through:

  • Adverse events during the study.
  • Laboratory exams.
  • Vital signs and body weight.
  • Physical evaluation.
  • Concomitant medication.


Original Secondary Outcome: Evaluate toxicity and tolerability in the administration of Imatinib in conjuction with chemotherapy in children with ALL Ph+. [ Time Frame: Up to 24 months ]

Information By: Hospital Santa Marcelina

Dates:
Date Received: October 15, 2010
Date Started:
Date Completion:
Last Updated: March 25, 2013
Last Verified: March 2013