Status:
UNKNOWN
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)
Lead Sponsor:
Renato Melaragno
Conditions:
Chronic Myeloid Leukemia (CML) With Philadelphia Chromosome-positive (Ph+)
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
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+.
Eligibility Criteria
Inclusion
- 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: ≥40.
- 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
- 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 \< 50000.
- INF-Α 48h before D1.
- Hydroxyurea 24h before D1.
- ARA-C doses \>100 mg/m2 for 5-7 days, 14 days before D1.
- Anthracyclines, Mitoxantrone or Etoposide 21 days before D1.
- Any other chemotherapeutic agent 28 days before D1.
- Hematopoietic Cell Transplantation (HCT) 6 weeks before D1.
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01221376
Start Date
February 1 2011
End Date
December 1 2013
Last Update
March 26 2013
Active Locations (1)
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1
Hospital Santa Marcelina
São Paulo, São Paulo, Brazil, 08270-070