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. ]
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