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

Renato Melaragno1 site in 1 country20 target enrollmentFebruary 2011

ConditionsChronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+)

InterventionsImatinib Mesylate

DrugsImatinib Mesylate

Overview

Phase: Phase 2
Intervention: Imatinib Mesylate
Conditions: Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+)
Sponsor: Renato Melaragno
Enrollment: 20
Locations: 1
Primary Endpoint: Evaluate the complete cytogenetic response with continuous-use of Imatinib.
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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+.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

December 2013

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Renato Melaragno

Responsible Party

Sponsor Investigator

Principal Investigator

Renato Melaragno

Hospital Santa Marcelina

Eligibility Criteria

Inclusion Criteria

•Diagnose: suspected CML (hematology and/or myelogram and/or immunophenotyping and/or Leukocyte alkaline phosphatase \[LAP\]) to be confirmed, after, by cytogenetic and/or molecular biology. OBS: only CML Ph+ newly-diagnose in chronic or accelerate phase; resistant CML Ph+ to Interferon α (INF-α), Hydroxyurea and/or low-dose ARA-C in chronic or accelerate phase; CML Ph+ with cytogenetic relapse after BMT, that didn't use Imatinib previously, in chronic or accelerate phase.
•Female patients of childbearing age, should have pregnancy test (blood βhCG) performed before treatment initiation. Effective contraception must be used. Pregnant women won't be included.
•Karnofsky and Lansky scale: ≥
•Life expectation \> 8 weeks.
•Laboratory: renal function (serum creatinine ≤ 1,5 x ULN and/or Clearance ≥70 ml/min/1,73m2), hepatic function (total bilirubin ≤ 1,5 x ULN, TGP \< 3 x ULN and albumin \> 2 g/dl.
•CNS toxicity ≤ II
•Cardiac function: normal ejection fraction.
•Signed ICF by child legal responsible.

Exclusion Criteria

•Patient receiving any other tyrosine kinase inhibitor (TKI).
•Pregnant patient or breastfeeding.
•Patient considered incapable to follow purposed treatment.
•Patients with molecular relapsed.
•Medications:
•Colony stimulating: it cannot be administered at least 1 week before treatment.
•Anticonvulsants: Imatinib is metabolized by P-450 enzyme, thereby subject cannot receive drug that activates the P-450 system. The anticonvulsants allowed are valproic acid and benzodiazepines.
•Anticoagulants: The use of warfarin (Marevan) is not allowed. If anticoagulant is needed, low-molecular-weight heparin (LMWH) can be used. Avoid anticoagulants with platelets \<
•INF-Α 48h before D
•Hydroxyurea 24h before D