Clinical Trial: Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)

Study Status: Suspended
Recruit Status: Unknown status
Study Type: Interventional

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

Brief Summary: The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.

Detailed Summary:
Sponsor: Renato Melaragno

Current Primary Outcome: Evaluate the complete cytogenetic response with continuous-use of Imatinib. [ Time Frame: Up to 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Evaluate the response to continuous-use of Imatinib and the toxicity and tolerability in children with CML Ph+. [ Time Frame: Up to 24 months ]

Original Secondary Outcome: Same as current

Information By: Hospital Santa Marcelina

Dates:
Date Received: October 14, 2010
Date Started: February 2011
Date Completion: December 2013
Last Updated: March 25, 2013
Last Verified: March 2013